Matias et al.

BMC Musculoskeletal Disorders (2016) 17:160

DOI 10.1186/s12891-016-1016-9

STUDY PROTOCOL Open Access

Protocol for evaluating the effects of a

therapeutic foot exercise program on injury
incidence, foot functionality and
biomechanics in long-distance runners:
a randomized controlled trial
Alessandra B. Matias1, Ulisses T. Taddei1, Marcos Duarte2 and Isabel C. N. Sacco1*

Abstract
Background: Overall performance, particularly in a very popular sports activity such as running, is typically
influenced by the status of the musculoskeletal system and the level of training and conditioning of the biological
structures. Any change in the musculoskeletal system’s biomechanics, especially in the feet and ankles, will strongly
influence the biomechanics of runners, possibly predisposing them to injuries. A thorough understanding of the
effects of a therapeutic approach focused on feet biomechanics, on strength and functionality of lower limb
muscles will contribute to the adoption of more effective therapeutic and preventive strategies for runners.
Methods/Design: A randomized, prospective controlled and parallel trial with blind assessment is designed to
study the effects of a "ground-up" therapeutic approach focused on the foot-ankle complex as it relates to the
incidence of running-related injuries in the lower limbs. One hundred and eleven (111) healthy long-distance
runners will be randomly assigned to either a control (CG) or intervention (IG) group. IG runners will participate in a
therapeutic exercise protocol for the foot-ankle for 8 weeks, with 1 directly supervised session and 3 remotely
supervised sessions per week. After the 8-week period, IG runners will keep exercising for the remaining 10 months
of the study, supervised only by web-enabled software three times a week. At baseline, 2 months, 4 months and
12 months, all runners will be assessed for running-related injuries (primary outcome), time for the occurrence of
the first injury, foot health and functionality, muscle trophism, intrinsic foot muscle strength, dynamic foot arch
strain and lower-limb biomechanics during walking and running (secondary outcomes).
Discussion: This is the first randomized clinical trial protocol to assess the effect of an exercise protocol that was
designed specifically for the foot-and-ankle complex on running-related injuries to the lower limbs of long-distance
runners. We intend to show that the proposed protocol is an innovative and effective approach to decreasing the
incidence of injuries. We also expect a lengthening in the time of occurrence of the first injury, an improvement in
foot function, an increase in foot muscle mass and strength and beneficial biomechanical changes while running
and walking after a year of exercising.
(Continued on next page)

* Correspondence: [email protected]
1
Department of Physical Therapy, Speech, and Occupational Therapy, School
of Medicine, University of São Paulo, Rua Cipotânea, 51 - Cidade Universitária,
05360-160 São Paulo, São Paulo, Brazil
Full list of author information is available at the end of the article

© 2016 Matias et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 2 of 11

(Continued from previous page)

Trial registration: Clinicaltrials.gov Identifier NCT02306148 (November 28, 2014) under the name “Effects of Foot
Strengthening on the Prevalence of Injuries in Long Distance Runners”. Committee of Ethics in Research of the School
of Medicine of the University of Sao Paulo (18/03/2015, Protocol # 031/15).
Keywords: Running, Sports injuries, Exercise therapy, Foot, Biomechanics

Background Even with this unique and specialized structure, a high

Human performance, particularly in one of the most prevalence of injuries associated with running practices
popular sports activities such as running, is typically influ- occurs in this complex. Among the most common hy-
enced by the state of the musculoskeletal system, either by potheses used to explain this high prevalence are factors
the level of training and conditioning of the biological such as the excessive ankle/foot pronation in the stance
structures, or by the aging process. Although popular phase of running [11], the lowering of the medial longi-
worldwide due to its low cost, versatility, convenience [1], tudinal arch due to navicular drop [12, 13], the alteration
and health benefits to people of all ages [2], running is as- of rigidity of the plantar arches [14], and the increase in
sociated with a high prevalence of lower extremity injuries impact and acceleration of the tibia during running [15].
(between 19.4 and 79.3 %) [3]. The occurrence of injuries Evidence suggests the importance of the intrinsic foot
limits the intended benefits by inducing changes in prac- musculature, showing that fatigue can cause a significant
tice habits [4] or temporary or even permanent cessation increase in pronation, which is evaluated by the navicu-
of running. In addition, injuries lead to increased costs lar drop [12]. In addition, weakness may be a risk factor
due to medical treatment and/or work absence [5]. for falls in the elderly population [16]. Therefore, it is
The understanding of risk factors associated with these understandable that the specific training of foot [13, 17]
injuries, particularly the intrinsic factors, can provide and ankle muscles [18–20] is an important tool that im-
important benefits for runners. Among these intrinsic proves functions and functionalities of the lower extrem-
factors, those that are noteworthy include biomechanical ities, as has been shown in recent studies [13, 19–21].
factors and muscle functionality of the lower extremities, In one of those studies, the unsupervised practice of a
particularly the feet. A systematic review by van der single exercise for the feet (short-foot exercise) four
Worp et al. [5] included 11 high-quality longitudinal times a week promoted a decrease in the navicular drop,
studies and concluded that alterations in the biomechan- an increase in the medial longitudinal arch index, and an
ical force distribution patterns, amount of training, his- increase in the functionality quality of the intrinsic foot
tory of previous injuries, increased index of the navicular muscles in asymptomatic individuals [13]. These results
drop, and the misalignment of the ankle, knee, and hip were maintained 1 month after the training had been
are among the main intrinsic risk factors for running- completed. Although the results of Mulligan and Cook
related injuries. In addition, extrinsic factors such as the [13] are promising, they only measured the foot function
training surface and the type of footwear are also relevant in static conditions and the unsupervised practice of an
risk factors [5]. It is noteworthy that out of these seven di- isolated exercise for 4 weeks may not have been suffi-
verse risk factors, two are related to the foot-ankle com- cient to cause a transfer of the static gains for a more
plex, demonstrating the importance of maintaining the dynamic task where the foot would be more robustly
health and functionality of its musculoskeletal structures utilized, according to the star excursion balance test. In
to prevent injuries. It is also believed that any biomechan- contrast, one study compared two groups: one group
ical alteration in the musculoskeletal system, in particular performed a 4-week period of short-foot exercises, in-
the foot-ankle complex, broadly influences a runner’s cluding 100 repetitions for five seconds each, and the
functionality, predisposing him/her to a lesser or greater second group performed a 4-week period of towel-curl
extent to injuries, in addition to the possibility of com- exercises with the same amount of exercise [20]. This
promising his/her quality of life [2, 6]. controlled study showed that both groups exhibited de-
The foot has a complex structure that can perform a creased displacement of the centre of pressure during
broad variety of functions in different postural and dy- the modified star excursion test. Therefore, a load in-
namic tasks [7, 8]. This versatility can only be achieved crease in the same exercises used by Mulligan and Cook
through its unique arch-shaped architecture and its [13] resulted in positive effects for postural control.
powerful intrinsic and extrinsic muscular activity, which The same short-foot exercise was practiced by individ-
is responsible for the maintenance and control of foot uals with flat feet in a randomized controlled trial to in-
arches, postural corrections during disturbances, and vestigate its effect on the use of foot orthoses [17]. The
torque generation during body displacement [9, 10]. protocol consisted of three to five sets of exercises with
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 3 of 11

five repetitions each, twice a day, for 8 weeks. In both which the incidence and prevalence of these injuries
study groups, the isometric force and the transversal sec- are reported) [4, 16, 24–27].
tion area of the abductor hallucis muscle were increased It is important to highlight that rehabilitation programs
after the interventions, with a significant increase in the rarely include the intrinsic muscles of the feet in their
group that used orthoses during exercises. These results therapeutic protocols. The present proposal uses a new
demonstrated that even in structurally unfavourable paradigm in which the focus of training and preventive in-
conditions, exercise for the foot muscles leads to import- terventions in runners is a “ground-up” approach rather
ant strength gains. It is noteworthy that even with a well- than the traditional "top-down" approach, which focuses
planned intervention, the lack of a control group and the on the hip strengthening. This new approach, advocated
evaluation of the muscle strength alone limit the study by Baltich et al. [23], will seek to improve the function of
conclusions. In addition, the study did not take into ac- the ankle-foot complex, which is directly associated with
count the potential clinical and functional changes of the the absortion and transmission of body forces to the
plantar arches, as performed by Goldmann et al. [19]. This ground and vice-versa during running.
group of researchers investigated the effects of the hallucis
flexors strengthening in the kinetic and kinematic of foot Hypotheses
and ankle during walking, running, and vertical jumping Our hypotheses are that the therapeutic exercise proto-
among university athletes. Training of the experimental col for the foot-ankle as practiced by long-distance rec-
group consisted of isometric contractions of the hallucis reational runners for 1 year will:
flexors at 90 % of the maximum voluntary contraction
using a dynamometer four times a week for 7 weeks. The H 1. Reduce the incidence of running-related injury in
authors observed a significant increase in the performance the lower limbs,
of vertical jumping and extensor and flexor momentum of H 2. Lengthening the time for the occurrence of the
the metatarsal-phalangeal joint and a gain of 60 to 70 % in first running-related injury in the lower limbs,
the strength of the hallucis flexors. This study shows that H 3. Increase intrinsic foot muscle strength,
the flexor muscles of the foot respond in a quick and in- H 4. Increase foot muscle cross-sectional area and
tense manner to training; even for simple training, the volume,
strengthening of the muscles in question results in global H 5. Improve foot health and functionality status,
kinematic and kinetic alterations. It would still be interest- H 6. Reduce dynamic strain on the foot’s longitudinal
ing to determine how long these gains would last after the arch during running and walking, and
completion of the intervention and whether more elabor- H 7. Produce beneficial biomechanical changes during
ate training, involving more muscles and different pos- running that denote an improvement in the mechanical
tures and loads, would alter the study outcome, especially efficiency of absorbing loads and propelling the body
with regard to foot biomechanics during locomotor tasks. while walking and running. Such changes would
The understanding of the effects of a therapeutic ap- include an increase in the ankle range of motion in the
proach focused on the foot biomechanics of walking and sagittal plane and increases in 1) ankle extensor
running, on the strength and functionality of lower ex- moment and power and 2) knee extensor moment and
tremity muscles will contribute to the adoption of more power during the second half of the stance phase.
effective therapeutic and preventive strategies for runners.
However, no evidence exists that supports the efficacy of Our aim is therefore to investigate the effects of a
the therapeutic exercises already used and recommended "ground-up" therapeutic approach focused on the foot-
for the health of the feet [7, 17, 19, 20, 22] with regard to ankle for 1 year as they relate to 1) the incidence of
preventing recurrent injuries in long-distance runners. running-related injuries in the lower limbs of long-distance
However, one research protocol aims to assess the effects runners, 2) time of occurrence of the first injury, 3) foot
of ankle and hip muscle strengthening and functional bal- health and functionality, 4) strength of the intrinsic foot
ance training on running mechanics, postural control, and muscles; 5) foot muscle trophism, 6) dynamic foot arch
injury incidence in novice runners with less than 1 year of strain and 7) lower-limb biomechanics during walking and
running experience but without focusing on the interven- running.
tion of intrinsic and extrinsic muscles of the feet [23].
Therefore, a controlled and randomized clinical trial Methods/Design
would determine whether these interventions are effi- Overview of the research design
cacious by using the incidence of running-related in- A randomized, prospective controlled and parallel trial
juries as the primary outcome and following both with blind assessment is designed to study the effects of a
intervention and control subjects during a period of "ground-up" therapeutic approach focused on the foot-
time equal to or greater than 1 year (the period during ankle concerning the incidence of running-related injuries
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 4 of 11

to the lower limbs of long-distance runners. This trial has Runners are not selected if they have other neuro-
an allocation ratio of 1:1. Its framework is exploratory to logical or orthopedic impairments (such as congenital
gather preliminary information on the intervention of foot malformations, stroke, cerebral palsy, poliomyelitis,
conducting a full scale trial. The trial follows all recom- rheumatoid arthritis, prosthesis or moderate or severe
mendations established by SPIRIT [28]. osteoarthritis), major vascular complications (venous or
Long-distance recreational runners are recruited from arterial ulcers), diabetes mellitus, sequelae from poorly
the vicinity of the city of São Paulo and referred to a healed fractures or prior lower-limb surgeries.
physical therapist, who performs the group allocation. These runners may use the running technique of
The participants are then referred to another physical fore-, mid- or rear-foot ground contact, which will be
therapist, who performs the initial blind assessment. All classified by the strike index, according to Cavanagh
runners allocated to the intervention group (IG) partici- and Lafortune [30].
pate in a protocol of therapeutic exercises for the foot- One hundred and eleven (111) runners will be re-
ankle complex for 8 weeks, with one session per week cruited by radio advertisements, print media and run-
supervised by a physical therapist and three sessions per ning association groups at their site of practice around
week remotely supervised by web-enabled software [29]. the city of São Paulo. The potential subjects will be
They receive access to the web software on the first day interviewed by telephone and, when selected, assessed in
and use it for 8 weeks. After the 8-week period, the IG the laboratory to confirm all the eligibility criteria. This
runners will continue exercising for 10 more months, first laboratory assessment represents the baseline con-
supervised only by the web software three times a week. dition (blind assessment).
The runners allocated to the control group (CG) do not The runners allocated to the IG will be treated during
receive any intervention training, but receive a placebo their locally supervised session at the Physical Therapy
stretching exercise program. Department in an ambulatory setting that assists all the
All runners will be assessed at baseline and 2 months physical therapy treatments of the Department, providing
(end of intervention). They are then assessed twice more a reliable therapeutic environment for the intervention.
for follow-up purposes, at 4 and 12 months after the
baseline. Assessments will concern the incidence of
running-related injuries (primary outcome), and all other Randomization, allocation and blinding
secondary outcomes. The randomization schedule was prepared using Clinstat
The design and flowchart of the protocol are pre- software [31] by an independent researcher (Researcher
sented in Fig. 1. The assessments are performed at the 1) who was not aware of the numeric code for the CG
Laboratory of Biomechanics of Human Movement and and IG groups. A numeric block randomization se-
Posture (LaBiMPH) at the Physical Therapy, Speech and quence will be kept in opaque envelopes.
Occupational Therapy department of the School of After the runners’ agreement to participate and assign-
Medicine of the University of São Paulo, São Paulo, ment in the research, the allocation into the groups will
Brazil. be made by another independent researcher (Researcher
2), who also will be unaware of the codes. Only the
Participants and recruitment physiotherapist (Researcher 3) responsible for the locally
This study is currently recruiting patients (study start supervised training knows who is receiving the interven-
date: April 2015) tion. Researcher 3 will also be responsible for the remote
The eligibility criteria for the volunteer runners are: monitoring of the training by web software [29] and tele-
phone. One physiotherapist (Researcher 4), who will also
– aged between 18 and 55 years old be blind to the treatment allocation, will be responsible
– at least 1 year of running experience for all clinical, functional and biomechanical assess-
– a weekly training distance greater than 20 km an ments. Both physiotherapists (researchers 3 and 4) will
less than 100 km as their main physical activity be blind to the block size used in the randomization
– within 2 months prior to baseline assessment, lack procedure.
of any lower limb musculoskeletal injury or pain To guarantee the blindness of researcher 4, before
that might lead to stopping running practice each evaluation, runners will be instructed not to reveal
– no prior experience within the last year of isolated whether they are in the CG or IG; their questions should
foot and ankle strength training be asked only to the physiotherapist in charge of web
– not receiving any physical therapy intervention software [29] and local training (Researcher 3).
– no history of using minimalist shoes for running The trial statistician will also be blind to treatment al-
practice location until the main treatment analysis has been
– no prior experience of barefoot running completed.
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 5 of 11

Fig. 1 Flow chart of the study’s design

Treatment arms (Researcher 4) once a week for 8 weeks, and a series of

The CG runners will receive a 5-min placebo routine of foot-ankle exercises to be performed under remote
warm-up and muscle-stretching exercises to be per- supervision through web software [29] three times a
formed immediately before every running practice dur- week for the full 1-year length of the study (1 year). Both
ing their 8-week study (Additional file 1: Table S3). locally (Additional file 1: Table S1) and remotely super-
The IG runners will receive a therapeutic foot-ankle vised therapeutic routines (Additional file 1: Table S2)
exercise protocol for strengthening and improving func- will take from 20 to 30 min. In particular, the remotely
tionality under the supervision of a physiotherapist supervised practice will be preferentially performed at
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 6 of 11

home; the web software includes written descriptions, the talar head, (2) observation of supra and infra malleo-
photos and videos of each exercise. lar curvature, (3) observation of the calcaneal frontal
Each week, IG runners will be requested to evaluate plane position, (4) observation of the bulging in the re-
the subjective effort of each exercise’s performance using gion of the talo-navicular joint, (5) observation of the
a score of 0 to 10 either with the web software [29] or to height and congruence of the medial longitudinal arch
the physiotherapist during locally supervised practice. If and (6) presence of abduction or adduction of the fore-
the effort score ranges from 0 to 5 and the runner’s per- foot. Scores reaching from -12 to +12 and normative
formance of each exercise is found adequate during the values are presented on the literature.
supervised session by the physiotherapist, the exercises Subjects will then be assessed for intrinsic foot muscles
will increase in difficulty according to the progression strength, lower-limb running kinematics and kinetics, and
chart in Additional file 1: Table S1 and Table S2. If the dynamic foot-arch strain. The feet of 30 % of the partici-
effort score ranges from 6 to 7, the exercise will not in- pants in each group (41 participants) will be imaged by
crease in difficulty and no progression would be done on magnetic resonance imaging (MRI) to assess trophism
that exercise. Thus, the runner remains in the same ex- and strength of the foot intrinsic muscles; this will be
ercise progression until he/she scores 0 to 5 in each par- scheduled for the same week of each subject’s baseline
ticular exercise. Finally, if an IG runner reports a score measurements.
from 8 to 10, the exercise will decrease in difficulty, if After baseline assessment, all subjects will be sched-
possible, until the subject is able to perform it without uled for two follow-ups assessments, one at 8 weeks and
pain or discomfort. the other at 16 weeks. They will maintain contact with
the Researcher 3 through the follow-up period by the
Assessments web software [29], e-mail and telephone.
A physiotherapist (Researcher 3) who is blind to group
allocation will perform all assessments. Each assessment Running-related injuries
will consist of taking a clinical history of personal details, Running-related injuries will be assessed initially at the
anthropometry, running practice details (years of prac- baseline and will be assessed continually throughout the
tice, weekly frequency and volume, usual shoe and train- study by the web software [29]. The definition of
ing surface, number of races and whether the runner running-related injury was set according to the study of
trains with a running coach), previous orthopedic sur- Macera et al. [4]. They stated that any musculoskeletal
gery, other physical activity practiced regularly (previous pain or injury that was caused by running practice and
to running practice or simultaneously with running) and that induces changes in the form, duration intensity or
an injury history concerning the most important risk frequency of training for at least 1 week will be consid-
factors previously published [3, 32, 33]. ered a running-related injury. Only lower-limb injuries
A foot-health status questionnaire [34] will be used to will be accounted during the 12-month period after the
characterize foot health and functionality. We will use a baseline assessment; both the incidence and time of oc-
Brazilian-Portuguese version (FHSQ-BR) translated and currence of the first injury will be analyzed.
validated by Ferreira et al. [35]. This instrument is di- If any subject presents a new injury during his or her
vided into three sections. Section I evaluates foot health participation in the study, the injury will be accounted
in four domains: foot pain, foot function, footwear and for and the intervention or placebo intervention will be
general foot health. Section II evaluates general health in discontinued, even though all subjects will still keep be-
four domains: general health, physical activity, social ing followed for the completion of the study.
capacity and vigour. Sections I and II are composed of
questions with answer options presented in affirmative Isometric intrinsic foot muscles strength
sentences and corresponding numbers. Section III col- Strength of the foot’s intrinsic muscles will be assessed
lects general demographic data of the individuals [36]. in trials using a pressure platform (EMED: Novel,
We will not use the scores from Section III. Each do- Germany) on which the subjects will place their domin-
main scores from 0 to 100 points, where 100 is the best ant foot while standing with knees extended. They will
condition and 0 the worst. push down as hard as possible using only their hallux
We will access variations in foot posture of the run- and toes, particularly the metatarsophalangeal joints and
ners using the Foot Posture Index (FPI) [36]. The FPI is not the hallux interphalangeal joint. A physiotherapist
a six component measures that allows multiple segment will determine whether the subject lifted the heel, and
evaluation of foot posture on a static measurement and inspect fluctuations in the line of gravity and trunk pos-
requires that subjects stand in their relaxed stance pos- ture during each trial. If any changes are observed in the
ition looking straight ahead while the assessment is in line of gravity or positioning of the heel or trunk, the
process. The assessment consists on the (1) palpation of trial will be excluded. Three trials will be completed on
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 7 of 11

each foot (left and right) according to Mickle et al. trial. In addition, three non-collinear reflective markers
(2006) [37]. Maximum force will be normalized by body will be fixed at two technique clusters. One of the clus-
weight and analyzed for hallux and toes areas separately. ters will be placed in the lateral thigh and the other over
the shank.
Foot muscle trophism and strength The laboratory coordinate system will be established at
One indirect method of measuring foot strength is one corner of the force plate and all initial calculations
through MRI, which, combined with other techniques, will be based on this coordinate system. Each lower-limb
offers good reliability and a way to follow changes in segment (shank and thigh), will be modelled based on
muscular volume [38]. In addition, MRI can facilitate surface markers as a rigid body with a local coordinate
understanding the etiology of running-related injuries system that coincides with the anatomical axes. Transla-
and rehabilitation of the foot-ankle complex [39]. tions and rotations of each segment will be reported
The MRI of the foot will be performed with a 1.5 T sys- relative to the neutral positions defined during the initial
tem. Foot images will be acquired by the same technician static standing trial. All joints will be considered to be
using a coil of four channels positioned in the magnetic spherical (i.e., with three rotational degrees of freedom).
centre. Participants will be placed in supine position with The foot will be modeled according to Leardini et al.
the ankle at 45° of plantar flexion inside the coil. Images [43]. That is, the calcaneus, mid-foot and metatarsus are
will be acquired in the frontal, sagittal and transverse considered rigid bodies and the longitudinal axis of the
planes to confirm the position of the feet, and the subject first, second and fifth metatarsal bones and proximal
will be repositioned if necessary. T1-weighted images of phalanx of the hallux will be tracked independently.
the entire foot length will be acquired perpendicular to Ground reaction forces will be acquired by a force
the plantar aspect of the foot using a spin-echo sequence plate (AMTI OR-6-1000, Watertown, MA, USA) with a
(repetition time = 500 ms, echo time = 16 ms, averages = 3, sampling frequency of 1 kHz embedded in the centre of
slice thickness = 4 mm, gap between slices = 0 mm, field of the walkway. Force and kinematic data acquisition will
view = 120 × 120 mm, flip angle = 90°, matrix = 512 × 512) be synchronized and sampled by an A/D card (AMTI,
[39]. The set of images will cover the distance between the DT 3002, 12 bits).
most proximal and most distal images in which every in- The subjects will go through a habituation period before
trinsic foot muscle is visible. the data acquisition to establish confidence and comfort
To assess changes in the cross-sectional area (CSA) in the laboratory environment, and to ensure appropriate
and volume of the intrinsic foot muscles, 30 % of the movement velocity. To assess lower-extremity running
subjects from each group will have MRI of the foot at mechanics, subjects will perform 10 valid over-ground
three times: baseline, 8 weeks and 16 weeks. walking trials and 10 valid over-ground running trials at a
The CSA will be measured by ImageJ planimeter soft- constant velocity (9.5 km/h to 10.5 km/s); these will be
ware [40]. Following, Miller et al. [14] for each muscle at monitored by two photoelectrical sensors (Speed Test Fit
each slice and muscle volume will be calculated by Model, Nova Odessa, Brazil).
multiplying the CSA of all slices for a muscle by their The automatic digitizing process, 3D reconstruction of
linear distance (4 mm) and adding these volumes. the markers’ positions and filtering of kinematic data will
be performed using AMASS software (C-motion, Kingston,
Walking and running biomechanics ON, Canada). Kinematic data will be processed using a
To ensure maximum reliability, all biomechanical testing zero-lag second-order low-pass filter with cutoff frequen-
sessions will be completed by the same researcher. cies of 6Hz for walking and 12 Hz for running. Ground
Gait and running kinematics will be acquired using reaction force data will be processed using a zero-lag low-
three-dimensional displacements of passive reflective pass Butterworth fourth-order filter with cutoff frequencies
markers (10 mm in diameter) tracked by nine infrared of 50Hz for walking and 200 Hz for running.
cameras at 100 Hz (OptiTrack FLEX: V100, Natural A bottom-up inverse dynamics method will be used to
Point, Corvallis, OR, USA) [41, 42]. Some 14 markers calculate the net moments in the sagittal and frontal planes
will be placed on the right subject’s foot according to of the ankle and knee joints using Visual3D software
Leardini’s protocol [43]. Extra markers will be placed at (C-motion, Kingston, ON, Canada). The human body will
the medial knee joint line, lateral knee joint line and bi- be modeled by three linked segments (foot, shank
laterally at the iliac spine antero-superior, superior as- and thigh) and the inertial properties will be based on
pect of the greater trochanter, and sacrum. These Dempster’s standard regression equations. The moment of
markers will be used to determine relative joint centres inertia and location of center of mass will be computed
of rotation for the longitudinal axis of the foot, ankle assuming the thigh and shank segments as cylinders.
and knee. The extra markers from the medial aspect of Calculation of all variables will be performed using a
the knee joint line will be removed during the dynamic custom-written MATLAB function (MathWorks, Natick,
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 8 of 11

MA, USA). Data of only one lower limb (randomly Interventions

chosen) per subject will be analyzed and compared. Runners allocated to the IG will receive a foot-ankle thera-
The following ankle kinematic variables will be analysed: peutic exercise protocol for strengthening and improving
maximum dorsiflexion at foot contact, maximum plantar- functionality. Part of the exercise protocol (12 exercises) is
flexion, maximum dorsiflexion at the toe-off and dorsiflex- to be performed once a week under the supervision of a
ion range of motion (ROM) in the sagittal plane during the physiotherapist for 8 weeks (Additional file 1: Table S1).
stance phase. The knee kinematic variables are: maximum And a series of eight foot-ankle exercises is also to be
flexion at foot contact, maximum extension, maximum performed three times a week remotely supervised by
flexion in the stance phase, ROM on sagittal plane, max- web software [29] (Additional file 1: Table S2) for the full
imum abduction and adduction in the stance phase. The 1-year completion time of the study. Each session,
foot kinematic variables are: elevation/drop of the longitu- whether supervised locally or remotely, lasts 20 to 30 min.
dinal arch angle and of the first, second and fifth metatarsal The therapeutic exercise protocol is described in details in
bones; rearfoot to forefoot rotation; transverse plane angle Additional file: 1 Table S1 and S2.
between first and second metatarsal bones and between Gradual and progressive difficulty will be offered to
second and fifth metatarsal bones; and maximum inversion the runner, respecting any limitation due to pain, fatigue
and eversion of the calcaneus (frontal plane). and/or decrease in performance during execution. The
The ankle and knee kinetic variables to be analysed are runners in the IG will access the web software [29] daily,
net ankle and knee moments normalized by body weight entering their data regarding performance of the foot
times height and power normalized by body weight in the exercise training and ranking their level of difficulty in
sagittal plane. The ground reaction force variables will be each exercise from 0 to 10.
normalized by body weight and are as followings: first peak During the locally supervised sessions, the physiotherapist
force (body weight – BW), second peak (BW), loading rate will focus on proper alignment of the foot-ankle segments,
80 [N/ms], defined as the force rate between 20 and 80 % especially if the runner has difficulty in maintaining it, in a
of the contact of the foot with the ground during the first way that allows no movement compensations.
peak; loading rate 100 [N/ms], as determined by the force Runners allocated to the CG will receive a 5-min
rate between 0 and 100 % of the first peak and push-off rate placebo warm-up and muscle stretching exercise routine
[N/ms], as defined as the rate of the second peak force, be- (Additional file 1: Table S3) that they are to perform for
tween the minimal values until the second peak. 8 weeks immediately before each running practice. This
placebo training can also be assessed and followed
Dynamic longitudinal foot arch strain through the web software [29]. The stretching exercises
The dynamic longitudinal foot arch strain will be measured are described in detail in Additional file: 1 Table S3. We
according to Liebermann et al. [44]. The measurement in- hypothesized that a warm-up combined with muscle
volves navicular height (NH), which is the minimum distance stretching exercises would not have any effect on foot
from the navicular tuberosity relative to the line formed by muscular strength and functionality, lower extremity
the first metatarsal head and the medial process of the calca- biomechanics or injury prevention.
neus. These three landmarks form a plane and NH is inde- Both groups will access the web software [29] daily,
pendent of rear-foot inversion or eversion. Arch strain can entering their running practice data (daily training
also be quantified by fitting a parabola to markers (with the duration and volume) and information concerning the
navicular head as the vertex) and then measuring the average occurrence of any injury event.
curvature at 100 points evenly spaced along the curve. The discontinuation criteria for the exercises during
any session includes cramps, moderate to intense pain,
Outcome measurements fatigue or any other condition that exposes the runner
The primary outcome measurement will be the inci- to any discomfort.
dence of running-related injuries in the lower limbs The discontinuation criteria for the training includes an
accounted at the end of 12 months of study. occurrence of a running-related injury in the lower limbs.
The secondary outcomes will be: 1) the time of the If any subject fails to access the web software [29]
occurrence of the first injury along the study period (time for three consecutive weeks without explanation, or
to event); 2) foot health and functionality (change from fails to attend the locally supervised training three
baseline); 3) foot, ankle and knee kinematics, ankle and consecutive times, that subject will be terminated
knee joint moments, and knee and ankle power during from the study.
walking and running (change from baseline); 4) strength To improve adherence, several actions will be per-
of the intrinsic foot muscles (change from baseline); formed by the researchers in the web software [29]. Data
5) foot muscle trophism (change from baseline); and regarding the subjects running practice, such as training
6) dynamic foot arch strain (change from baseline). volume, time of practice and occurrence of injuries, will
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 9 of 11

be reported to the web software, which will summarize Effect sizes (Cohen´s d coefficient) will also be provided
it and make it viewable in the users’ area. In addition, between baseline and 2 months and between 2 months
for the duration of the study, runners' responses in the and follow-up (4 and 12 months), if the intervention
web software concerning their foot-ankle exercise prac- shows any treatment effect. The missing data will be
tice and running training will be stored and be accessible treated by imputation methods depending on the type of
to the researchers and subjects at any time. If any sub- the missing data we will face: missing completely at ran-
ject fails to log in to the web software for more than five dom, missing at random, or missing not at random [47].
consecutive days, an e-mail will be automatically be sent,
asking the subject to log in to his or her account and re- Discussion
port data on the training (or lack of it) for the past week. This clinical trial will provide important data on foot-
The physiotherapist responsible for the therapeutic training effectiveness, its influence on the incidence of
protocol will make phone contact with subjects who fail injuries and its efficacy on strengthening the muscles of the
to attend to any of the weekly locally supervised ses- foot-ankle complex. It will also facilitate the identification
sions. They will also make phone contact with subjects of risk factors and biomechanical mechanisms involved in
who do not respond to e-mail reminders from the web injury processes and prevention. We also intend to contrib-
software. Subjects will also be contacted by personal ute new evidence that could be used as a guide for further
phone calls if data they reported on the web software is studies on biomechanical changes in dynamic tasks result-
found to be inconsistent [45]. ing from the strengthening of the foot-ankle complex.
After the period of intervention and after 12 weeks of The few existing clinical trials that have proposed exercise
follow up all runners will be questioned about their sat- protocols to reduce the incidence of runners’ injuries have
isfaction to the training protocol with one question (Did not included the incidence of injury as a primary outcome.
you enjoy doing the exercises?) with three answer possi- They also have had short follow-up periods and usually
bilities (No; A Little; A lot). To avoid evaluation bias, failed to follow the subjects’ adherence to the program and
runners will answer this question secretly through an the correctness of exercise performance throughout the
online-unidentified form sent to their e-mail. Runners study [13, 17, 19, 20]. In contrast, this trial has the incidence
will be informed about the anonymity and this form will of running-related injuries as a primary outcome, will have a
only be accessed after completion of the study. long period of follow-up (12 months), proposes an interven-
For the duration of the trial, subjects will be advised not tion training protocol with several exercises that are easy to
to engage in any new physical activity or preventive train- perform with short durations for each session (20–30 min)
ing protocols for the foot and ankle. If any subject cannot and does not require subjects to be continuously supervised
avoid such behavior, he or she must report this situation by a health professional. In addition, it utilizes open-access
during web software [29] access. Concomitant care, such web software [29] that will support adherence control.
as physical therapy, acupuncture or other conventional We understand that the number of MRIs that we are
medical care, will not be permitted except for runners performing (on 30 % of the subjects) is limited and might
who are injured during the study. At the end of 12 months, prevent a broad conclusion about changes in intrinsic foot
CG participants that are interested will receive access to muscle cross-sectional area (CSA) and volume.
the software for the foot exercise protocol. Running-related injuries in this population cause inter-
ruptions and abandonment of physical activity. They also
Sample size and statistical analysis could lead to the development of chronic injury that
The sample size calculation was made using an effect size would prevent the practice of other sports and hence
of 0.28 (proportion), considering the categorical primary frustrate the individual’s pursuit of a healthy lifestyle.
outcome variable, which is the incidence of running- Runners are constantly looking for ways to remain free
related lower-limb injuries [33]. A sample size of 101 run- from injury and the information they receive from coa-
ners is needed to provide 80 % power to detect a moderate ches or media is often conflicting and varied [48]. Our
effect difference between the highest and lowest group protocol has the potential to change the course of this
injury incidence medians, assuming an alpha of 0.05 and a vicious cycle experienced by long-distance runners.
χ2 (chi-squared test) statistical design – contingency tables If our hypothesis that such an exercise protocol reduces
(df = 1) [46]. Assuming a 10 % dropout rate during the the incidence of running-related injuries to long-distance
study, a sample size of 111 runners is needed. runners is confirmed, it could be easily incorporated into
The statistical analysis will be based on intention-to- their warm-up routine prior to running practice.
treat analysis, and mixed general linear models of analysis
of variance for repeated measure will be used to detect Ethics approval and consent to participate
treatment-time interactions (α = 5 %). The outcome mea- This trial was approved by the Ethics Committee of the
sures will be compared at baseline, 2, 4 and 12 months. School of Medicine of the University of São Paulo (Protocol
Matias et al. BMC Musculoskeletal Disorders (2016) 17:160 Page 10 of 11

number n°031/15). Additionally, this trial is registered in 05360-160 São Paulo, São Paulo, Brazil. 2Federal University of ABC, Biomedical
ClinicalTrials.gov (a service of U.S. National Institutes of Engineering, São Bernardo, São Paulo, Brazil.

Health) Identifier NCT02306148 (November 28, 2014) Received: 2 March 2016 Accepted: 7 April 2016
under the name “Effects of Foot Strengthening on the Preva-
lence of Injuries in Long Distance Runners”. All runners will
be asked for written informed consent according to the
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Additional file 1

Table S1 - Exercises included in the supervised sessions by a physiotherapist.

Approximate
Name Execution Training Volume Progression Progression Parameter
Duration

Massage
Sitting, with leg crossed over the
other, massage the sole of your
feet with both hands, for 20
1 set of 20
seconds. Rub your foot in a - - 40 Seconds
seconds each foot
circular motion using your
thumb. Do the same on the
other foot.

Toes manipulation

Sitting, with leg crossed over the

other, hold each toe and slowly 1 set of 10 times -
- 1 minute
spin side to side, like a screw. Do each finger
with all toes.

Slowly slide your foot on the ball

1 set of 30 -
Rubber ball slide throughout the foot sole from - 1 minute
seconds each foot
the heel to the fingertips.
 Feet tapping

With the heel fixed, tap your 1: 1x30

foot as fast as possible. Starts repetitions;
seated on a chair, and do with 1 set of 30 2: 2x30 Being able to perform the set without pain or muscle
1-2 minutes
both feet at the same time. After repetitions repetitions; cramp after the completion of the set.
you learn, do the same tapping 3: 2x40
standing. repetitions

Forefoot ascend

1: 1x30
Standing, ascend and descend repetitions;
on forefoot. Start standing, using 1 set of 30 2: 2x30 Being able to perform the set without pain or muscle
1-2 minutes
both feet. Use a chair or table to repetitions repetitions; cramp after the completion of the set.
keep balance. 3: 2x40
repetitions
Invert/Evert asymmetric
1: Sitting: 1x10
repetitions;
2: Standing:
Sitting, with 90 degrees of knee 1 set of 10
1x10 repetitions
and ankle flexion, perform repetitions Being able to perform the set without pain or muscle
;
asymmetrical foot inversion maintaining each cramp after the completion of the set, and without loss 1-2 minutes
3: Standing
(lifting medial side) and eversion position for 1 of balance.
1x20 repetitions
(lifting lateral side). second.
maintaining
each position
for 2 seconds.

Foot abduction

1: 2x10
Standing, using a resistance repetitions;
2 sets of 10
band around the forefoot, 2: 4x10 Being able to perform the set without pain or muscle
repetitions each 1-6 minutes
perform foot abduction and repetitions; cramp after the completion of the set.
foot
return to the original position 3: 6x10
repetitions.

Toes and ankle flexion

1: 1x10
Sitting posture, using a
repetitions;
resistance band around the 1 sets of 10
2: 2x10 Being able to perform the set without pain or muscle
forefoot, perform ankle and repetitions each 1-3 minutes
repetitions; cramp after the completion of the set.
toes flexion and return to the foot
3: 3x10
original position
repetitions.
Grab and hold squeeze ball

1: Sitting posture
1x5 repetitions;
Grab and hold a squeeze ball 1 sets of 5 2: Standing
with all the toes, raise it from the
repetitions each posture Being able to perform the set without pain or muscle
floor and place it back to it’s 2-6 minutes
foot holding the 2x5 repetitions; cramp after the completion of the set.
original position. Always keep the
ball for 5 seconds 3: Standing
heel fixed on the ground.
posture
3x5 repetitions.

Squeeze toes separators

Sitting position, with 90 degrees 1: 1x10

of knee and ankle flexion, adduct repetitions;
1 sets of 10
and abduct, squeeze the toes 2: 2x10 Being able to perform the set without pain or muscle
repetitions each 2-6 minutes
separators for one second repetitions; cramp after the completion of the set.
always keeping the heel fixed on foot
3: 3x10
the ground. repetitions.

Squeeze ball with little toes

Grab and hold a squeeze ball 1 sets of 5 Progression

Being able to perform the set without pain or muscle
with the metatarsophalangeal repetitions each requires raising
cramp after the completion of the set and being able to 2 minutes
region and place it back to the foot holding the squeeze balls
starting position. hardness. hold abduction for the stipulated time.
ball for 5 seconds
Toes Abduction/adduction
1: Sitting posture
1x10 repetitions;
1 sets of 10 2: Standing
repetitions each posture
Sitting position, with 90 degrees
foot holding 2x10 repetitions; Being able to perform the set without pain or muscle
of knee and ankle flexion, adduct
abduction for 2 3: Standing cramp after the completion of the set and being able to 1-2 minutes
and abduct toes holding each
seconds and posture hold abduction for the stipulated time.
position for 2 seconds.
adduction for 2 2x10 repetitions
seconds. holding
abduction/abduct
ion for 5 seconds.

Short-foot exercise Sitting, with 90 degrees of 1 set of 10 1: Sitting 4-6 minutes

knee and ankle flexion, repetitions each 1x10
approximate the head of the foot, maintaining repetitions;
first metatarsal toward the 5 seconds each 2: Standing
heel without toe flexion, contraction. 1x10
“shortening” the feet. The repetitions;
forefoot and heel should not 3: Single leg Being able to perform the set without pain or muscle
get off the ground. stance cramp after the completion of the set.
1x10
repetitions.
Plantar arch raise
1: Sitting
1x10
repetitions;
1 set of 10
Sitting, raise the plantar arch 2: Standing
repetitions each
in an arch shape. The heel 1x10 Being able to perform the set without pain or muscle
foot, maintaining 4-6 minutes
and fingertips should not get repetitions; cramp after the completion of the set.
5 seconds each
off the ground. 3: Single leg
contraction.
stance
1x10
repetitions.
Table S2 – Exercises included in the remotely supervised sessions in the web software.

Approximate
Name Execution Training Volume Progression Progression Parameter
Duration

Massage

Sitting, with leg crossed over

the other, massage the sole of
your feet with both hands, for
1 set of 20
20 seconds. Rub your foot in a - - 40 seconds
seconds each foot
circular motion using your
thumb. Do the same on the
other foot.
Toes manipulation

Sitting, with leg crossed over

the other, hold each toe and 1 set of 10 times
- - 1 minute
slowly spin side to side, like a each finger
screw. Do with all toes.

Feet tapping
1: 1x30
With the heel fixed, tap your
repetitions;
foot as fast as possible. Starts
2: 2x30
seated on a chair, and do with 1 set of 30 Being able to perform the set without pain or muscle
repetitions; 1-2 minutes
both feet at the same time. repetitions cramp after the completion of the set.
3: 2x40
After you learn, do the same
repetitions ;
tapping standing.

Forefoot accend

1: 1x30
Standing, ascend and descend repetitions;
on forefoot. Start standing, 1 set of 30 2: 2x30 Being able to perform the set without pain or muscle
1-2 minutes
using both feet. Use a chair or repetitions repetitions; cramp after the fulfillment.
table to keep balance. 3: 2x40
repetitions
Invert/Evert symetric

1: Sitting
Sitting, with 90 degrees of
1 set of 10 1x10
knee and ankle flexion,
repetitions repetitions; Being able to perform the set without pain or muscle
perform symmetrical foot
maintaining each 2: Standing cramp after the completion of the set and without loss 1-2 minutes
inversion (lifting medial side)
position for 1 1x10 repetitions of balance.
and eversion (lifting lateral
second. 3: Standing
side).
1x20 repetitions

Cotton ball grab

1: 1x10
Rubber ball grab While sitting, with the heel in repetitions with
a fixed position, grip the cotton ball;
object with the toes, lifting off 1 set of 10 2:2x10
Being able to perform the set without pain or muscle
from the ground and placing it repetitions each repetitions with 3-6 minutes
cramp after the completion of the set
back to its original position. foot. rubber ball;
Do the same with the other 3: 3x10
foot. repetitions with
Pen grab a pen.
1-5 toe alternate
1: Sitting
1x10
Sitting, with the heel fixed 1 set of 10 repetitions;
and contacting the floor, repetitions each 2: Standing
Being able to perform the set without pain or muscle
alternately pull the hallux and foot, maintaining 1x10
cramp after the completion of the set and with high 2-3 minutes
the little toe on the floor. Do finger pressure on repetitions;
control of speed and motion.
it slowly and under complete the ground for 1 3: Single leg
control. second. stance
1x10
repetitions.

Toes abduction
1: Sitting
1x10
1 set of 10 repetitions;
repetitions each 2: Standing
Sitting, with 90 degrees of
foot, maintaining 2x10 Being able to perform the set without pain or muscle
knee and ankle flexion,
2 seconds repetitions; cramp after the completion of the set and be able to 1-2 minutes
abduct and adduct the toes
abducted and 2 3: Standing keep the abduction and adduction time.
rhythmically.
seconds on 2x10
adducted. repetitions
maintained for
5 seconds

Plantar arch raise 1: Sitting

1x10
repetitions;
1 set of 10
Sitting, raise the plantar arch 2: Standing
repetitions each
in an arch shape. The heel and 1x10 Being able to perform the set without pain or muscle
foot, maintaining 4-6 minutes
fingertips should not get off repetitions; cramp after the completion of the set.
5 seconds each
the ground. 3: Single leg
contraction.
stance
1x10
repetitions.
Short-foot exercise
1: Sitting
Sitting, with 90 degrees of 1x10
knee and ankle flexion, repetitions;
1 set of 10
approximate the head of the 2: Standing
repetitions each
first metatarsal toward the 1x10 Being able to perform the set without pain or muscle
foot, maintaining 4-6 minutes
heel without toe flexion, repetitions; cramp after the completion of the set.
5 seconds each
“shortening” the feet. The 3: Single leg
contraction.
forefoot and heel should not stance
get off the ground. 1x10
repetitions.

Toes grasping gait

1: 1x10 steps;
Walking “grasping” the toes Being able to perform the set in the time described and
2: 2x10 steps;
when they touch the ground. 1 set of 10 steps. without pain or muscle cramp after the completion of 1-3 minutes
3: 3x10 steps;
Each step grasp for 3 seconds. the set.

Toes abducted gait

1: 1x10
repetitions;
Walking abducting the toes
1 set of 3 steps 2: 2x10
when the foot touches the Being able to perform the set without pain or muscle
forward and 3 repetitions; 2-6 minutes
ground until take the foot off cramp after the completion of the set.
steps backwards. 3: 3x10
the ground.
repetitions;
Table S3 – Warm up and stretching exercises.

Name Execution Training Volume Approximate Duration

Calf stretch

Standing in front of a wall, keep one leg in front of the other. The
front leg with the knee flexed and the rear leg with the knee
1 set of 20 seconds each leg. 40 seconds
extended. Lean forward at the ankle, keeping both heel on the
ground, stretching the calf muscles.

Quadriceps stretch

Standing on one foot, pull the heel towards the bottom,

stretching the anterior muscles of the thigh. If necessary, use a 1 set of 20 seconds each leg. 40 seconds
wall for support.
Fingertip-to-floor

Standing, with your back straight, bend your trunk forward,

keeping the knee straight, trying to touch the fingertip to the 1 set of 20 seconds each leg. 40 seconds
ground.

Lateral stretch (1)

Standing, with the back straight and with leg crossed over the
other, bend the trunk forward, keeping both knees straight, trying 1 set of 20 seconds each leg. 40 seconds
to touch the fingertip to the ground.
Adductors stretch

Sitting, with back straight, knees apart and the sole of feet
together, apply gentle pressure to your knees directed to the 1 set of 20 seconds each leg. 40 seconds
floor.

Pretzel Stretch

Lying, with leg crossed over the other, interlace your fingers on
1 set of 20 seconds each leg. 40 seconds
the back of the thigh, pulling the leg crossed towards the trunk.

Lateral stretch (2)

Lying with open arms, flex and adduct the hip directing the knee
1 set of 20 seconds each leg. 40 seconds
to the hand of the opposite side.