This brief report summarizes a study on the effectiveness of the Key Grip Orthosis, a wrist extension-operated lateral key grip orthosis designed to improve hand function in people with C5-C7 spinal cord injuries. The study found that the orthosis significantly improved users' ability to perform functional tasks and grip strength over 6 weeks compared to without the orthosis. However, the study had limitations including a small sample size and short duration. While preliminary evidence suggests the orthosis may improve key grip function, further research is needed to evaluate long-term benefits and safety before widespread use.
This brief report summarizes a study on the effectiveness of the Key Grip Orthosis, a wrist extension-operated lateral key grip orthosis designed to improve hand function in people with C5-C7 spinal cord injuries. The study found that the orthosis significantly improved users' ability to perform functional tasks and grip strength over 6 weeks compared to without the orthosis. However, the study had limitations including a small sample size and short duration. While preliminary evidence suggests the orthosis may improve key grip function, further research is needed to evaluate long-term benefits and safety before widespread use.
This brief report summarizes a study on the effectiveness of the Key Grip Orthosis, a wrist extension-operated lateral key grip orthosis designed to improve hand function in people with C5-C7 spinal cord injuries. The study found that the orthosis significantly improved users' ability to perform functional tasks and grip strength over 6 weeks compared to without the orthosis. However, the study had limitations including a small sample size and short duration. While preliminary evidence suggests the orthosis may improve key grip function, further research is needed to evaluate long-term benefits and safety before widespread use.
This brief report summarizes a study on the effectiveness of the Key Grip Orthosis, a wrist extension-operated lateral key grip orthosis designed to improve hand function in people with C5-C7 spinal cord injuries. The study found that the orthosis significantly improved users' ability to perform functional tasks and grip strength over 6 weeks compared to without the orthosis. However, the study had limitations including a small sample size and short duration. While preliminary evidence suggests the orthosis may improve key grip function, further research is needed to evaluate long-term benefits and safety before widespread use.
Reviewer Hannah Smeel e and Peter Larking Date Report Compl eted 18 March 2009
Important Note: T h e p u rp ose of th i s bri ef rep ort i s to su m m ari se i n form ati on on th e effecti ven ess of th e K ey G ri p O rth osi s an d to p rovi d e best p racti ce ad vi ce. T h e evi d en ce h as been system ati cally d evelop ed accord i n g to a p red efi n ed m eth od ology. I t i s n ot i n ten d ed to rep lace cli n i cal ju d gem en t, or be u sed as a cli n i cal p rotocol. A reason able attem p t h as been m ad e to fi n d an d revi ew p ap ers relevan t to th e focu s of th i s rep ort, h owever i t d oes n ot clai m to be exh au sti ve. T h e d ocu m en t h as been p rep ared by th e staff of th e evi d en ce based H ealth care Ad vi sory G rou p , AC C . T h e con ten t d oes n o t n ecessari ly rep resen t th e offi ci al vi ew of AC C or rep resen t AC C p oli cy. T h i s rep ort i s based u p on i n fo rm ati on su p p li ed u p to Jan u ary 2009 A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n 1. Background T h i s rep ort i s abou t a wri st exten si on -op erated lateral k ey gri p orth osi s recen tly d esi gn ed by I n d u stri al R esearch L td for p eop le wi th C 5-C 7 sp i n al cord i n ju ri es 1 . T h e orth osi s was d esi gn ed to i m p rove h an d fu n cti on i n th i s grou p of p eop le wi th i m p ai red fi n ger m ovem en t an d en able th em to carry ou t m ore acti vi ti es of d ai ly li vi n g (AD L s) i n d ep en d en tly. T h e d evi ce fi ts over th e u sers wri st an d p alm an d i s a si m i lar si ze to a wri st gu ard . A flexi ble cable ru n s alon g th e an teri or su rface of th e forearm an d attach es to a ri n g arou n d th e th u m b. I t u ti li ses wri st exten si on to p rod u ce a lateral k ey gri p between th e th u m b an d i n d ex fi n ger. U n li k e si m i lar d evi ces m an u factu red by oth er com p an i es, th i s orth osi s i s so ft an d can ap p aren tly be i n d ep en d en tly d on n ed an d d offed b y th e u ser.
2. Investigation T h e orth oti c d evi ce was tri alled wi th 7, C 5-C 7 tetrap legi c m ales, 6 of wh i ch com p leted th e tri al. 4 p arti ci p an ts h ad been recen tly i n ju red an d 2 h ad been i n ju red fo r m ore th an 4 years. E ach p arti ci p an t u sed th e d evi ce for at least h alf an h o u r p er d ay for 6 week s. T h e i n vesti gators m easu red th e lateral k ey gri p force th e p arti ci p an ts cou ld p rod u ce an d th e n u m ber of fu n cti on al task s th ey cou ld carry ou t from a grou p of 1 3 p i n ch task s. T h e m easu rem en ts were tak en wi th an d wi th ou t th e orth osi s at th e com m en cem en t of th e tri al, an d rep eated wi th an d wi th ou t th e orth osi s 6 week s later.
T h e i n vesti gators fou n d th at T h e m ean n u m ber of fu n cti on al task s ach i eved (e.g. verti cal zi p op en , fork +p u tty li ft) was si gn i fi can tly greater wi th th e orth osi s after 6 week s of trai n i n g (average n u m ber of fu n cti on al task s ach i eved , 1 1 .3 wi th , 6.2 wi th ou t, p <0.0001 ). T h e m ean lateral k ey gri p force (i n N ewton s) p rod u ced , was si gn i fi can tly greater wi th th e orth osi s th an wi th ou t both at on e week an d agai n at 6 week s (p =0.001 2) (at on e week , 5.4 N ewton s v. 2.3; at si x week s, 1 3.1 v. 4.3). All u sers cou ld i n d ep en d en tly d on an d d off th e orth osi s (alth ou gh som e assi stan ce was requ i red i f weari n g th i ck cloth es).
T h e m ai n li m i tati on s of th e stu d y were: O n ly a sm all n u m ber of p arti ci p an ts were i n volved . H owever th e resu lts were stati sti cally si gn i fi can t an d are li k ely to be ap p li cable to oth er C 5-C 7 tetrap legi cs T h ere d i d n ot ap p ear to be an y observer bli n d i n g, alth ou gh th e op p ortu n i ty for th i s was li m i ted T h e task s m easu red m ostly requ i red th e object to be alread y h eld i n th e u sers gri p . T h e research ers h ave si n ce con fi rm ed th at p arti ci p an ts h ad to i n d ep en d en tly grasp th e objects T h ere i s n o evi d en ce on wh eth er p arti ci p an ts fou n d th e orth osi s u sefu l for d ay-to- d ay li vi n g or wh eth er i t i n creased th ei r i n d ep en d en ce (th e research ers h ave si n ce A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n Page 2 con fi rm ed th at n o assessm en ts were m ad e of fu n cti on d u ri n g d ay to d ay li vi n g bu t clai m th at at least som e d i d u se i t an d fou n d i t u sefu l) T h e stu d y d i d n ot exam i n e wh at th e p arti ci p an ts th ou gh t of th e orth osi s or wh eth er th ey wi sh ed to con ti n u e to u se i t T h e tri al d esi gn d i d n ot ad equ ately allow fo r ch an ges i n p h ysi cal fu n cti on wi th ti m e as n o con tro l grou p was i n clu d ed . F ou r of th e p arti ci p an ts wh o en tered th e tri al were less th an 6 m on th s p ost i n ju ry an d oth er stu d i es h ave sh own th at p h ysi cal fu n cti on m ay i m p rove wi th ti m e p o st i n ju ry; su ch i m p rovem en ts h ave been gi ven as a reason fo r d i scard i n g oth er u p p er extrem i ty d evi ces 3 (th e research ers su ggest th at aban d on m en t of th e d evi ce as th e p ati en t regai n s fu n cti on i s an i d eal ou tcom e h owever th ere i s n o evi d en ce th at th e d evi ce i m p roves fu n cti on oth er th an wou ld occu r n atu rally d u ri n g recovery)(th e research ers h ave also si n ce su ggested th at th e orth osi s trai n ed correct u se of th e ten od esi s gri p wh i ch som e i n d i vi d u als oth erwi se fou n d d i ffi cu lt to m aster) N o reason i s gi ven as to wh y on e of th e seven wh o en tered i n to th e tri al d rop p ed ou t (i n a later com m u n i cati on i t was sai d th at th e reason for th e wi th d rawal was d u e to d ecreased flexi on of th e m etacarp al-p h alan geal joi n ts an d was n ot able to u se th e orth osi s) T h e d u rati on of th e stu d y at 6 week s was relati vely sh ort; by th e en d of th e si x week s all of th e p arti ci p an ts were ach i evi n g m ost of th e task s wi th th e orth osi s. I t i s n ot clear i f fu rth er i m p rovem en ts cou ld be exp ected from a lon ger tri al or wh eth er fu n cti on ali ty h ad reach ed a p lateau I f an y ad verse even ts occu rred th ey were n ot rep orted . I n vi ew of th e sh ort d u rati on of th e tri al an d th e li m i ted ti m e th e orth osi s was u sed each d ay, som e cau ti on abou t i ts lon g term safety i s ap p rop ri ate.
A li teratu re search was con d u cted u si n g O vi d M ed li n e p latform , E m base (1 996-2009), M ed li n e (1 996-2009) an d Am ed (1 985-2009) to look for evalu ati on s of si m i lar d evi ces. T h e search located several arti cles on an k le-foot orth oses, p rosth eti c h an d s, fu n cti on al electri cal sti m u lati on an d su rgi cal m an agem en t of h an d fu n cti on . O n ly 3 arti cles, fo u n d on Am ed an d p u bli sh ed i n th e Am eri can Jou rn al of O ccu p ati on al T h erap y p ri or to 1 995, were p oten ti ally abou t si m i lar orth oses an d th e fu ll text of th ese arti cles was obtai n ed . O f th ese 3 arti cles, 2 were i rrelevan t (on e was abou t stati c orth oses, an d th e oth er d escri bed equ i p m en t typ i cally p rescri bed to qu ad rap legi cs). T h e th i rd arti cle con tai n ed d escri p ti on s of a ratch et wri st-h an d orth osi s, an d a wri st-d ri ven wri st-h an d orth osi s 2 . T h ese d evi ces also ap p eared to p rod u ce a lateral k ey gri p , bu t u n li k e th e orth osi s d escri bed i n th i s rep ort, th ey were sti ff an d ri gi d an d th e arti cle d i d n ot d escri be an y evalu ati on . T h e au th ors d i d h owever n ote th at ed u cati on p rogram m es were i m p ortan t to m axi m i se ben efi ts from th ese d evi ces.
3. Costs I t i s u n d erstood th at each k ey gri p orth osi s costs ap p roxi m ately $1 50 based on a p u rch ase ord er of 20 u n i ts. A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n Page 3 4. Concl usions B ased on on e sm all tri al, th ere i s som e p reli m i n ary evi d en ce th at th e k ey gri p orth osi s m an u factu red by I n d u stri al R esearch L td ., m ay i m p rove k ey gri p fu n cti on for C 5-C 7 tetrap legi cs. T h ere ap p ears to be a su bstan ti al effect wh en th e d evi ce i s u sed regu larly for 6 week s. T h ere i s n o evi d en ce avai lable on th e lon g-term ben efi ts of th e d evi ce or wh eth er lon g- term u se of th e d evi ce resu lts i n an y ad verse ou tcom es (su ch as m u scu losk eletal p ai n ). I n vi ew of th e low cost of th e orth osi s an d i ts p oten ti al to i m p rove th e i n d ep en d en ce of C 5-C 7 tetrap legi cs, fu rth er stu d i es are warran ted . I f AC C d eci d es to p u rch ase th e p rod u ct, p ati en t ben efi t from u se an d ad verse effects sh ou ld be m on i tored lon g-term .
5. References
1 . K i n g M J, Verk aai k JK , N i ch olls A. A Wri st E xten si on O p erated L ateral K ey G ri p O rth osi s for P eop le wi th T etrap legi a: I n d u stri al R esearch L td ., 2008. 2 . B au m garten JM . U p p er E xtrem i ty Ad ap ti on s for th e P erson wi th Q u ad ri p legi a. Clin Phys Ther 1 985;6:21 9-242. 3 . G arber SL , G regori o T L . U p p er extrem i ty assi sti ve d evi ces: Assessm en t of u se by sp i n al cord i n ju red p ati en ts wi th qu ad ri p legi a. The Amer J Occ Ther; 44: 1 26-1 31 .
6. Appendices
1. Search Strategies EMBASE 1996 to 2009 Week 03 # Searches Results Search Type 1 Spinal Cord Injury/ 12057 Advanced 2 Quadriplegia/ 3742 Advanced 3 1 or 2 14888 Advanced 4 Tenodesis/ or tenodesis orthosis.mp. 81 Advanced 5 exp hand function/ 10996 Advanced 6 exp arm prosthesis/ or exp hand prosthesis/ or exp orthosis/ 2625 Advanced 7 orthosis.mp. 2559 Advanced 8 orthoses.mp. 852 Advanced 9 6 or 4 or 8 or 7 3270 Advanced A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n Page 4 A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n Page 5 10 9 and 5 172 Advanced 11 9 and 3 196 Advanced 12 11 or 10 343 Advanced
Ovid MEDLINE(R) 1996 to January Week 1 2009 # Searches Results Search Type 1 exp Hand Strength/ 4875 Advanced 2 exp Finger Joint/ 1322 Advanced 3 Pinch Strength/ 36 Advanced 4 exp Orthotic Devices/ 3255 Advanced 5 4 and (1 or 2 or 3) 45 Advanced 6 from 5 keep 2, 8, 17, 22-23, 28, 33 7 Advanced 7 exp Quadriplegia/ 2298 Advanced 8 exp Paraplegia/ 2957 Advanced 9 exp Spinal Cord Injuries/ 13910 Advanced 10 Paralysis/ 3110 Advanced 11 Paresis/ 2253 Advanced 12 or/7-11 22246 Advanced 13 12 and (hand or hands or wrist$ or finger$ or thumb or thumbs or upper extremit$).mp. 1644 Advanced 14 13 and 4 37 Advanced 15 13 and (orthosis or orthoses).mp. 30 Advanced 16 14 or 15 41 Advanced 17 16 not 5 33 Advanced 18 from 17 keep 2, 6-7, 10, 13, 15 6 Advanced 19 6 or 18 13 Advanced
AMED (Allied and Complementary Medicine) 1985 to January 2009 # Searches Results Search Type 1 exp Orthotic devices/ 1416 Advanced A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n Page 6 2 exp Equipment design/ 4119 Advanced 3 exp Hand strength/ 392 Advanced 4 exp Arm/ 4715 Advanced 5 4 or 3 5020 Advanced 6 1 or 2 5132 Advanced 7 6 and 5 333 Advanced 8 exp Spinal cord injuries/ 3370 Advanced 9 exp Quadriplegia/ 424 Advanced 10 8 or 9 3672 Advanced 11 7 and 10 22 Advanced 12 from 11 keep 12, 19, 21 3 Advanced
Study Design Participants Intervention Outcomes Level of Evidence King MJ, Verkaaik JK, Nicholls A; 2008 C ase seri es wi th m easu res tak en before an d after 7 p arti ci p an ts 6 week s d u rati o n N o con trol grou p /bli n d i n g N o ob server bli n d i n g 1 /7 p arti ci p an ts d rop p ed o u t H an d fu n cti on m easu red at week 1 an d week 6. F u n cti on wi th orth osi s co m p ared to fu n cti on wi th ou t orth osi s. M ales wi th C 5-C 7 sp i n al i n ju ry 4 p arti ci p an ts less th an 4 m on th s p ost- i n ju ry, 2 m ore th an 4 years p ost-i n ju ry. N o i n form ati on on p ati en tsages or wh eth er th ei r i n ju ri es were com p lete (th ou gh p resu m ab ly th ey were). K ey G ri p O rth osi s a soft orth osi s wh i ch u ti li ses wri st exten si on to p rod u ce a lateral k ey gri p P arti ci p an ts ei th er u sed th e orth osi s for h alf an h ou r a d ay, 5 ti m es p er week , d u ri n g h an d class sessi on s, or for at least h alf an h ou r d ai ly for fu n cti on al task s i n th e h om e en vi ron m en t. N o i n form ati on on com p li can ce wi th i n terven ti on . L ateral k ey gri p force (i n N ewton s) was si gn i fi can tly greater wi th th e orth osi s at both ti m e p o i n ts (p =0 .0 01 2). N u m b er of fu n cti on al task s ach i eved (from a grou p of 1 3 p i n ch task s) was si gn i fi can tly greater wi th th e orth osi s after 6 week s of trai n i n g (1 1 .3 wi th , 6 . 2 wi th ou t, p < 0 .0 00 1 ). O ver th e 6 week p eri od both th e lateral k ey gri p force an d th e n u m ber of fu n cti on al task s ach i eved i n creased si gn i fi can tly. All p arti ci p an ts cou ld d on an d d off th e orth osi s i n d ep en d en tly. N o ad verse even ts rep orted . SI G N level 3 A c c i d e n t C o m p e n s a t i o n C o r p o r a t i o n 2. Characteristics of Incl uded Studies