Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Phase: NA
Conditions: Stroke
Sponsor: VA Office of Research and Development

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Page 1 of 11 
 
 
 
 
 
 
COVER PAGE 
 
 
 
 
 
PROTOCOL TITLE: 
 
Novel training environment to normalize altered finger force direction post stroke 
 
 
PRINCIPAL INVESTIGATOR: 
 
Na Jin Seo, PhD 
 
 
Trial registration:  
 
 
Clinicaltrials.gov NCT03995069 
 
 
 
 

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1.0 
Objectives / Specific Aims 
The objective of this project is to determine if 3D finger force training is an effective tool in 
restoring hand function post stroke.  
Aim 1: Determine the effect of 3D finger force training on behavioral hand function  
Hypothesis: Hand function will improve more in the experimental group than the control group.  
Aim 2: Determine the effect of 3D finger force training on finger force direction control 
Hypothesis: The experimental group will achieve greater ability to direct finger force than 
control after the training. 
Aim 3: Determine the biomechanical mechanisms underlying improvement in force direction 
control 
Hypothesis: The training results in improved muscular coordination. 
 
2.0 
Background 
Our hands constitute our primary means of interacting with the external world. They allow us to 
dexterously manipulate objects such as tools, dishes, and smart phones. This exquisite 
manipulation requires precise generation of forces at the finger and thumb tips.  Unfortunately, 
control of these forces can be profoundly impaired following stroke, thereby resulting in the 
object being mishandled, or not handled at all, and failure at task execution. Thus, hand 
function and use and utility of the entire upper extremity can be dramatically diminished, with 
ramifications for self-care, work, and leisure.  
Both finger movement1,2 and force control3 are impaired after stroke. The central nervous 
system uses two separate neural strategies to control digit force generation vs. movement.4 
Therefore, both neural strategies must be independently rehabilitated to achieve proper hand 
function. Clinical motor learning literature suggests that the best treatment modality involves 
training in volitional movements with explicit feedback. Current therapy focuses on training of 
volitional movement with explicit feedback.5 Unfortunately, digit force control is rarely explicitly 
addressed in therapy.  
This gap in treatment is due to a lack of tools to provide explicit feedback on patients’ volitional 
finger force generation. To address this unmet need, we developed a novel tool for practice of 
volitional three-dimensional (3D) force generation with explicit feedback. 
 
3.0 
Intervention to be studied: 3D finger force training (Fig 1) 
 
Subjects will place their fingers into thimbles that are firmly attachable to the grip surfaces that are 
attached to force sensors (Fig 1).  
 
Subjects in the experimental group will practice generating their finger force in various directions in 
3D. Subjects will receive explicit visual feedback on force magnitudes in 3D in the computer screen 
(Fig 1).  
 
The control group will practice 1D force generation with no explicit feedback on the non-target 
direction force, thus no feedback on directional control of force. This control condition is more 
accessible in clinic and cheaper, but does not provide explicit feedback for digit force direction that 

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is essential for successful object manipulation based on our preliminary data. This experimental vs. 
control comparison will determine the therapeutic value of the 3D force feedback vs. 1D. 
 
 
 
Figure 1. Finger force training setup 
(Thumb) 
Required 
 
 
Actual normal force 
Target circles 
Shear force 
 
 
 
direction 
Shear force in 
 
 
direction 
Computer screen: 
  
(Index finger) 
Alternative
pinch pos
6-axis 
d cells 
Load cells 
nonparetic 
paretic 
Bilateral training 

Versi o n # 1 0; Versi o n Date 6/ 2 3/ 2 0 2 2 
 
 
  
Pa ge 4 of 1 1  
 
Tr ai ni n g will pr o gr e s s b y v ar yi n g p o st ur e r e q uir e m e nt s (t o w ar d f or e ar m pr o n ati o n, el b o w e xt e n si o n, 
s h o ul d er fl e xi o n, 6  a n d w h ol e b o d y fr o m s e at e d t o st a n di n g t o w al ki n g 7 ) a n d i n cr e a si n g fi n g er f or c e 
l e v el,8  i ntr o d u ci n g  f e e d b a c k  d el a y  (t o  s oli cit  i n cr e a s e d  r eli a n c e  o n  i ntri n si c  s e n s or y  f e e d b a c k 
pr o c e s si n g), a n d i n c or p or ati n g u nil at er al/ bil at er al tr ai ni n g  f or b ot h gr o u p s. E xt er n al ar m s u p p ort m a y 
i niti all y b e pr o vi d e d ( Fi g 2A ) b ut t h e e xt e nt of ar m s u p p ort will b e r e d u c e d a s t h e s u bj e ct pr o gr e s s e s. 
T h e w h ol e b o d y p o st ur e will pr o gr e s s fr o m sitti n g t o st a n di n g t o w al ki n g wit h a h ar n e s s f or s af et y  
( Fi g 2B) , o nl y if t h e p arti ci p a nt s c a n st a n d or w al k wit h o ut s u p p ort . R e g ar dl e s s of t h e w h ol e b o d y 
p o st ur e, t h e tr ai ni n g will b e t h e fi n g er f or c e c o ntr ol ( Fi g 1).  
 
 
 
( A)  
  
  
 
( B) 
Fi g ur e 2. Ar m s u p p ort ( A) a n d h ar n e s s ( B)  
 
T h er e i s n o F D A a p pr o v al o n t hi s fi n g er f or c e c o ntr ol tr ai ni n g. T h e fi n g er f or c e tr ai ni n g d o e s n ot a p pl y 
a n y e n er g y t o t h e s u bj e ct s. T h e tr ai ni n g s et u p m e a s ur e s s u bj e ct s’ v ol u nt ar y fi n g er f or c e g e n er ati o n 
a n d pr o vi d e s vi s u al f e e d b a c k t o t h e s u bj e ct s o n a c o m p ut er s cr e e n  ( Fi g 1).  
 
5. 0  
I n cl u si o n a n d E x cl u si o n Crit eri a/ St u d y P o p ul ati o n 
I n cl u si o n Crit eri a  
•   A g e: 1 8 y e ar s ol d or ol d er  
•   S ur vi v e d a str o k e at l e a st 3 m o nt h s a g o  
•   M o d er at e t o s e v er e h a n d i m p air m e nt ( C h e d o k e- M c M a st er H a n d St a g e 2- 4) 
•   A bilit y t o g e n er at e p al p a bl e v oliti o n al gri p f or c e u p o n c u e 
•   S uffi ci e nt c o g niti v e a bilit y t o p arti ci p at e ( NI H Str o k e S c al e, NI H S S, Q u e sti o n s a n d 
C o m m a n d s s c or e = 0- 1) 
•   A bilit y t o r e c o g ni z e all q u a dr a nt s of t h e vi s u al fi el d ( NI H S S Vi s u al Fi el d T e st s c or e = 0) 
E x cl u si o n Crit eri a 
•   C o n c urr e nt u p p er li m b r e h a bilit ati o n  
•   I n a bilit y t o f oll o w 2- st e p c o m m a n d s 

Versi o n # 1 0; Versi o n Date 6/ 2 3/ 2 0 2 2 
 
 
  
Pa ge 5 of 1 1  
•   S e v er e m u s cl e t o n e pr o hi biti n g p a s si v e m o v e m e nt of t h e fi n g er s or pr o p er pl a c e m e nt of t h e 
fi n g er s o n t h e f or c e s e n s or s a s n e e d e d t o p arti ci p at e i n t h e trai ni n g ( M o difi e d A s h w ort h 
S c al e, M A S = 4- 5 o ut of 5) 
•   C h a n g e i n s p a sti cit y m e di c ati o n or b ot uli n u m t o xi n i nj e cti o n i n t h e u p p er li m b wit hi n 3 
m o nt h s pri or t o or d uri n g e nr oll m e nt 
•   T ot al s e n s or y l o s s o n fi n g erti p s ( NI H S S S e n s or y s c or e = 2) 
•   C o m or bi dit y ( e. g., ort h o p a e di c c o n diti o n s t h at li mit r a n g e s of m oti o n, pr e m or bi d n e ur ol o gi c 
c o n diti o n s)  
•   L a n g u a g e b arri er or c o g niti v e i m p air m e nt t h at pr e cl u d e s pr o vi di n g c o n s e nt 
 
•  S cr e e ni n g : Eli gi bilit y will b e d et er mi n e d b a s e d o n t h e p ot e nti al p arti cip a nt’ s v er b al 
di s cl o s ur e or st a n d ar di z e d cli ni c al a s s e s s m e nt s. T o mi ni mi z e tr a v el a n d f a c e-t o-f a c e 
c o nt a ct, vi d e o s cr e e ni n g m a y al s o b e u s e d u si n g HI P A A- c o m pli a nt vi d e o a p pli c ati o n s ( e. g., 
Mi cr o s oft T e a m s).  
•  S e x/r a c e/ et h ni cit y : W e will i n cl u d e str o k e s ur vi v or s of all g e n d er s a n d all r a ci al a n d/ or 
et h ni c gr o u p s t h at ar e r e pr e s e nt ati v e of t h e d e m o gr a p hi c s of A m eri c a n s w h o h a d a str o k e. 
W e will n ot e x cl u d e p e o pl e b a s e d o n s e x/ g e n d er, r a ci al or et h ni c gr o u p. W e will ai m t o 
c o n str u ct a p arti ci p a nt p o ol t h at m at c h e s p o st- str o k e s ur vi v or di stri b uti o n s i n S o ut h 
C ar oli n a. O ur t ar g et e nr oll m e nt f or s e x a n d r a c e/ et h ni cit y b a s e d o n t h e d e m o gr a p hi c d at a 
a n d str o k e s ur v eill a n c e d at a i n S o ut h C ar oli n a. T hi s r e cr uit m e nt i s p o s si bl e, b e c a u s e w e 
p erf or m o utr e a c h t o r e cr uit str o k e s ur vi v or s of all s e x, r a ci al , a n d et h ni c gr o u p s, a s s h o w n 
b y o ur str o k e r e gi stri e s c urr e ntl y h a vi n g 4 8 % f e m al e a n d 4 3 % et h ni c/r a ci al mi n oriti e s.  
•  C hil dr e n : C hil dr e n u n d er t h e a g e of 1 8 y e ar s will b e e x cl u d e d. T h e r atio n al e f or e x cl u si o n 
of c hil dr e n i s t h at str o k e pr e d o mi n a ntl y o c c ur s i n a d ult s, a n d str o k e i s v er y r ar e i n c hil dr e n. 
I m p ort a ntl y, t h e s e r ar e c a s e s m a y a ct u all y diff er i n t h eir eti ol o g y fr o m t h e p arti ci p a nt s w e 
pr o p o s e t o st u d y.   
 
6. 0  
N u m b er of S u bj e ct s 
A t ot al of 6 0 s u bj e ct s will b e r e cr uit e d.  
 
7. 0  
S etti n g 
All h u m a n s u bj e ct i n v ol v e m e nt will t a k e pl a c e at R al p h H. J o h n s o n V A M e di c al C e nt er.  
 
8. 0  
R e cr uit m e nt M et h o d s 
•   
W e will g et r ef err al s fr o m t h e V A C h arl e st o n N e ur o Cli ni c. W e will e nr oll p arti ci p a nt s u p o n 
di s c h ar g e fr o m u s u al- c ar e t h er a p y. T h e V A C h arl e st o n N e ur o Cli ni c tr e at s > 3 0 0 n e w 
str o k e c a s e s e v er y y e ar.  
•   
T h e I R B- a p pr o v e d V A str o k e r e gi str y (I R B # 4 3 1 0 7 “ V A Str o k e R e h a bilit ati o n R e s e ar c h 
D at a b a s e”) h a s c o nt a ct a n d d e m o gr a p hi c i nf or m ati o n f or 4 9 7 p o st- str o k e V et er a n s w h o 
w er e s e e n at t h e R al p h H. J o h n s o n V A M e di c al C e nt er a n d ar e i nt er e st e d i n p arti ci p ati n g 
i n r e s e ar c h. W e will r e cr uit fr o m t h e V A str o k e r e gi str y. 

Versi o n # 1 0; Versi o n Date 6/ 2 3/ 2 0 2 2 
 
 
  
Pa ge 6 of 1 1  
•   
A d e di c at e d r e cr uit er vi sit s l o c al cli ni c s a n d p erf or m s c o m m u nit y o utr e a c h t o e nr oll 
p ati e nt s i nt o t h e R E S T O R E str o k e r e gi str y s u p p ort e d b y t h e NI H C O B R E-f u n d e d Str o k e 
R e c o v er y R e s e ar c h C e nt er ( Pr o # 0 0 0 3 7 8 0 3). W e will r e cr uit fr o m R E S T O R E.  
•   
A c h art r e vi e w will b e c o n d u ct e d f or r e s e ar c h p ur p o s e s. P ot e nti all y eli gi bl e p ati e nt s will b e 
i d e ntifi e d. W e will s u b mit a R e s e ar c h D at a R e q u e st t o o bt ai n a r e cr uit m e nt r e p ort of 
M U S C p ati e nt s w h o p ot e nti all y m e et eli gi bilit y crit eri a. T h e p ot e nti all y eli gi bl e p ati e nt s w h o 
h a v e a gr e e d t o b e c o nt a ct e d f or f ut ur e r e s e ar c h b y l o g gi n g t h ei r M U S C R e s e ar c h 
P er mi s si o n s pr ef er e n c e s i n M y C h art will b e c o nt a ct e d b y p h o n e, l ett er, or e m ail a n d 
i n vit e d t o p arti ci p at e. Ot h er p ati e nt s w h o di d n ot u p d at e t h eir M U S C R e s e ar c h 
P er mi s si o n s i n M y C h art m a y al s o b e c ol d- c o nt a ct e d b y p h o n e, l ett er, or e m ail t o b e 
i nf or m e d of t h e st u d y if it i s a p pr o pri at e. W e will n ot c ol d- c o nt a ct a n y p ati e nt s w h o h a v e 
c h o s e n t o o pt- o ut of r e c ei vi n g c o nt a ct a b o ut r e s e ar c h or w h o h a v e m et t h e m a xi m u m 
n u m b er of c o nt a ct att e m pt s at t h e ti m e of r e cr uit m e nt.  
•   
Si mil arl y, p ot e nti all y eli gi bl e p ati e nt s i n t h e V A m e di c al r e c or d s will b e c o nt a ct e d b y 
p h o n e, l ett er, or e m ail.  
•   
I n a d diti o n, a d v erti s e m e nt vi a i nt er n et ( e. g., S o ut h C ar oli n a R e s e ar c h St u di e s Dir e ct or y) 
will b e u s e d.  
 
9. 0  
C o n s e nt Pr o c e s s 
T h e c o n s e nt pr o c e s s will t a k e pl a c e i n a pri v at e r o o m w h e n t h e p ot e nti al p arti ci p a nt c o m e s t o 
t h e l a b or at or y o n a s c h e d ul e d ti m e a gr e e d u p o n b et w e e n t h e st u dy p er s o n n el a n d t h e 
p arti ci p a nt. T h e c o nt e nt of t h e c o n s e nt will b e v er b all y e x pl ai n e d t o t h e p arti ci p a nt a n d t h e 
p arti ci p a nt will b e a s k e d t o r ai s e a n y q u e sti o n s a n d c o n c er n s. If t h e p er s o n r e q u e st s a w aiti n g 
p eri o d, t h e n o n e will b e gi v e n. If t h e p er s o n d e sir e s t o c o n s e nt i m m e di at el y, t h e n t h e p er s o n 
will pr o vi d e c o n s e nt i m m e di at el y. 
 
1 0. 0  St u d y D e si g n / M et h o d s 
•  
St u d y d e si g n : Th e st u d y will b e a r a n d o mi z e d c o ntr oll e d tri al. S u bj e ct s will b e r a n d o ml y 
a s si g n e d t o eit h er t h e e x p eri m e nt al or c o ntr ol gr o u p u si n g bl o c k r a n d o mi z ati o n t o e n s ur e 
b al a n c e ( h alf i n t h e e x p eri m e nt al, h alf i n t h e c o ntr ol). Bl o c k si z e s will b e r a n d o m ( 4, 6, or 
8). T h e bl o c k r a n d o mi z ati o n will b e str atifi e d e q u all y b y t h e m o d er at e v s. s e v er e 
i m p air m e nt l e v el ( wit h t h e F u gl-M e y er U p p er E xtr e mit y a s s e s s m e nt c ut- off s c or e of 1 9
9 ).  
•  
I nt er v e nti o n s c h e d ul e: All s u bj e ct s will u n d er g o a p pr o xi m at el y t w o -h o ur f or c e tr ai ni n g, 3 
ti m e s p er w e e k f or 6 w e e k s. T h e e x p eri m e nt al gr o u p will pr a cti c e f or v ari o u s t ar g et f or c e 
dir e cti o n t o e x pl or e t h e 3 D f or c e w or k s p a c e a n d r e c ei v e e x pli cit f e e d b a c k i n 3 D f or c e, w hil e 
t h e c o ntr ol gr o u p will r e c ei v e f e e d b a c k i n 1 D o n a c o m p ut er s cre e n (i n t ar g et dir e cti o n o nl y 
wit h n o e x pli cit f e e d b a c k o n ot h er dir e cti o n s, t h u s n o tr ai ni n g i n f or c e dir e cti o n al c o ntr ol, m u c h 
li k e si m pl e s q u e e z e b all r e p etiti o n s). T h e tr ai ni n g d o s e will b e c o ntr oll e d b y h a vi n g a mi ni m u m 
of 8 s et s wit h 1 4 t ar g et s e a c h ( a t ot al of 1 1 2 t ar g et s) p er s e s si o n, wit h m a xi m u m 3 0 s e c 
all o w e d f or e a c h t ar g et ( u p t o 5 6 mi n/ s e s si o n).  
•  
E v al u ati o n s : O ut c o m e m e a s ur e s will b e a s s e s s e d at b a s eli n e, i m m e di at el y aft e r 2 a n d 4 
w e e k s of f or c e tr ai ni n g, at p o st ( wit hi n a w e e k aft er 6- w k f or c e tr ai ni n g), a n d 1 m o nt h aft er 
tr ai ni n g e n d s (i. e. f oll o w- u p t o a s s e s s r et e nti o n). T h e b a s eli n e m e a s ur e m e nt will t a k e 
pl a c e 3 ti m e s o v er 3 w e e k s pri or t o tr ai ni n g t o e x a mi n e t h e b a s eli n e r e c o v er y r at e. E a c h 
e v al u ati o n vi sit will t a k e 1- 5 h o ur s. E v al u ati o n f or e a c h o ut c o m e i s d et ail e d b el o w. 

Versi o n # 1 0; Versi o n Date 6/ 2 3/ 2 0 2 2 
 
 
  
Pa ge 7 of 1 1  
•   
B e h a vi or al h a n d f u n cti o n: S u bj e ct s’ u p p er e xtr e mit y f u n cti o n will b e a s s e s s e d u si n g 
c o n v e nti o n al cli ni c al a s s e s s m e nt s u s e d i n o c c u p ati o n al/ p h y si c al  t h er a p y i n w hi c h 
p arti ci p a nt s will b e a s k e d t o m o v e t h e aff e ct e d h a n d a n d ar m, g r a s p o bj e ct s a n d p erf or m 
pr e s cri b e d t a s k s ( e. g., lifti n g a n o bj e ct off t h e t a bl e, r el e a si n g t h e o bj e ct i nt o a bi n, 
gri p pi n g h ar d, r e a c hi n g a s hi g h or f ar a s p o s si bl e, o p e ni n g t h e h a n d a s m u c h a s p o s si bl e). 
T h e s e t e st s will b e vi d e ot a p e d f or s c ori n g. T h e j oi nt p o siti o n s a n d m u s cl e a cti vit y d uri n g 
t h e s e t a s k s will al s o b e r e c or d e d. T h e b e h a vi or al h a n d f u n cti o n a s s e s s m e nt s will l a st 
a p pr o xi m at el y 1 hr. 
•   
I nt er vi e w: S u bj e ct s will b e i nt er vi e w e d aft er t h e c o m pl eti o n of t h e i nt er v e nti o n i n a s e mi-
str u ct ur e d i nt er vi e w f or m at, t o di s c u s s t h e i m p a ct of t h e tr ai n i n g o n t h eir d a y-t o- d a y lif e. 
T h e i nt er vi e w will b e a u di o-r e c or d e d. T h e i nt er vi e w will l a st a p pr o xi m at el y 3 0 mi n.  
 
1 2. 0  D at a M a n a g e m e nt  
•   
R e cr uit m e nt pr oj e ct s ar e h o u s e d i n R E D C a p. O nl y st u d y p er s o n n el will h a v e a c c e s s t o 
t h e R E D C a p d at a b a s e w hil e a cti v el y e nr olli n g f or t h e st u d y.  
•   
P o w er a n al y si s: T h e st u d y w a s d e si g n e d pri m aril y t o p o w er t h e a n al y si s of di git f or c e 
dir e cti o n. F or t h e pri m ar y p o w er a n al y si s, b a s e d o n pr e vi o u s st u di e s, a cli ni c all y 
m e a ni n gf ul diff er e n c e i n f or c e dir e cti o n w a s d e e m e d t o b e 6º. R e d u cti o n of f or c e d e vi ati o n 
t o a v al u e b el o w < 2 0º i s e x p e ct e d t o r e s ult i n i n cr e a s e d a bility t o m a ni p ul at e o bj e ct s. 1 0  
T h e m e a n f or c e d e vi ati o n f or str o k e s ur vi v or s i n C h e d o k e H a n d S t a g e 2- 4 i s a nti ci p at e d t o 
b e 2 5. 6º b a s e d o n o ur pr eli mi n ar y d at a. 1 0  T h er ef or e, a 6º c h a n g e i n f or c e dir e cti o n i s 
e x p e ct e d t o l e a d t o a s u b st a nti al f u n cti o n al i m pr o v e m e nt.  
O ur st u d y i s l o n git u di n al wit h 4 pri m ar y ti m e p oi nt s. I n t h e a n al y s e s, a n a ut or e gr e s si v e 
( A R( 1)) c o v ari a n c e str u ct ur e will b e c o n si d er e d f or t h e wit hi n- s u bj e ct c orr el ati o n s ( w hil e 
ot h er str u ct ur e s will al s o b e e x a mi n e d). F or a st a n d ar d d e vi ati o n of 6. 6º ( b a s e d o n t h e 
f or c e dir e cti o n d at a i n o ur pr eli mi n ar y st u d y), a n al p h a l e v el of 0. 0 5, 9 0 % p o w er, a n d t h e 
A R( 1) c orr el ati o n b et w e e n o b s er v ati o n s o n t h e s a m e s u bj e ct of 0 . 8 ( b a s e d o n t h e 
pr eli mi n ar y st u d y), a s a m pl e si z e of 2 2 p arti ci p a nt s p er gr o u p will b e a d e q u at e t o d et e ct a 
diff er e n c e of 6º. A dj u sti n g f or a n e x p e ct e d attriti o n r at e of 1 5 % a n d s cr e e n f ail ur e r at e of 
1 2 %, a s a m pl e of 3 0 p er gr o u p (f or a t ot al of n = 6 0) i s pl a n n e d.   
•   
A n al y si s: T h e pri m ar y f or m al a n al y si s f or t h e pri m ar y o ut c o m e m e a s ur e will b e a r e p e at e d 
m e a s ur e s g e n er al li n e ar m o d el wit h a n A R( 1) str u ct ur e ( alt h o u g h  ot h er str u ct ur e s will b e 
c o n si d er e d a n d c o m p ar e d). T h e pri m ar y i n d e p e n d e nt v ari a bl e s ar e  gr o u p ( e x p eri m e nt al 
v s. c o ntr ol), e v al u ati o n ti m e ( b a s eli n e ( 3 r d), 2, 4, a n d 6 w e e k s f or t h e pri m ar y a n al y s e s; all 
3 b a s eli n e s a n d f oll o w- u p will b e i n cl u d e d i n s u b s e q u e nt a n al y s e s), a n d t h eir i nt er a ct i o n 
( gr o u p´  e v al u ati o n ti m e). I n a d diti o n, w e will i n cl u d e s e x a s a n i n d e p e n d e nt v ari a bl e al o n g 
wit h it s i nt er a cti o n s t o st u d y g e n d er diff er e n c e s. If t h e gr o u p ´ e v al u ati o n ti m e i nt er a cti o n i s 
si g nifi c a nt, t h e n t h e m ai n alt er n ati v e h y p ot h e si s of i nt er e st, t h at at 6 w e e k s t h er e i s 
diff er e n c e b et w e e n t h e t w o gr o u p s, will b e t e st e d u si n g p o st- h o c t e st s. Gr e at er 
i m pr o v e m e nt f or t h e e x p eri m e nt al t h a n c o ntr ol gr o u p will s u p p ort t h e h y p ot h e si s.  
T h e ti m e c o ur s e of t h e eff e ct will al s o b e e x a mi n e d o v er t h e 6- w e e k tr ai ni n g p eri o d a n d at 
f oll o w- u p. A s di git f or c e dir e cti o n will b e r e c or d e d t hr o u g h o ut t h e tr ai ni n g s e s si o n s, 
s p a g h etti pl ot s will b e g e n er at e d o v er t h e 1 8 tr ai ni n g s e s si o n s al o n g wit h e v al u ati o n 
s e s si o n s t o e x a mi n e a m or e d et ail e d ti m e c o ur s e. Al s o i n s e c o n d ar y a n al y si s, ot h er 
c o v ari at e s s u c h a s i niti al i m p air m e nt l e v el s will b e i n cl u d e d. If mi s si n g d at a ari s e, m ulti pl e 
i m p ut ati o n m et h o d s will b e a p pli e d u n d er t h e a s s u m pti o n of mis si n g at r a n d o m ( M A R).  

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Pa ge 8 of 1 1  
T h e s a m e a n al y si s a p pr o a c h will b e a p pli e d t o e a c h s e c o n d ar y o u t c o m e m e a s ur e. 
B o nf err o ni c orr e cti o n will b e a p pli e d t o a dj u st f or m ulti pl e c o m p ari s o n s. D at a r e d u cti o n 
m et h o d s m a y al s o b e c o n si d er e d.  
•   
Q u alit ati v e A n al y si s: I nt er vi e w s will b e a u di o r e c or d e d a n d tr a n s cri b e d v er b ati m. 
Q u alit ati v e d at a will b e a n al y z e d u si n g t h e p o p ul ar c o n str u cti vi st gr o u n d e d t h e or y 
m et h o d ol o g y.
1 1, 1 2  T h e ‘ Fr a m e w or k A n al y si s’ c o m m o nl y  u s e d i n a p pli e d q u alit ati v e 
r e s e ar c h will g ui d e t h e d at a a n al y si s pr o c e s s1 3  a n d i n cl u d e s fi v e k e y st a g e s: 
f a mili ari z ati o n, i d e ntif yi n g a t h e m ati c fr a m e w or k, i n d e xi n g, c harti n g, m a p pi n g, a n d 
i nt er pr et ati o n.1 4, 1 5  T w o r e s e ar c h er s will c o n d u ct a hi g h-l e v el r e a di n g of tr a n s cri pt s t o 
c o n s oli d at e t h e d at a i nt o a n al y z a bl e u nit s. 1 4  T e xt s e g m e nt s r a n gi n g fr o m a p hr a s e t o 
s e v er al s e nt e n c e s m a y b e a s si g n e d c o d e s a pri ori ( e. g., ar e a s o f si g nifi c a n c e t o t hi s 
pr oj e ct). A d diti o n al c o d e s will b e cr e at e d t o c a pt ur e n e w t h e m e s e m er gi n g fr o m t h e d at a. 
T w o r e s e ar c h er s will i n d e p e n d e ntl y r e a d a p pr o xi m at el y 2 5 % of t h e tr a n s cri pt s t o e st a bli s h 
i nt er-r at er r eli a bilit y f or t h e fi n al c o di n g hi er ar c h y t h at will b e ap pli e d t o a n al y z e t h e all 
d at a. Di s a gr e e m e nt s i n d efi niti o n s or a s si g n m e nt of c o d e s will b e r e s ol v e d t hr o u g h gr o u p 
di s c u s si o n a n d f urt h er r e vi e w of t h e d at a t o a c hi e v e c o n s e n s u s. A t h e m ati c c o d e b o o k will 
b e cr e at e d t o d o c u m e nt t h e fi n al c o d e s. Q u alit ati v e m e m o s will b e u s e d t hr o u g h o ut t h e 
a n al y si s t o d o c u m e nt r efl e cti v e n ot e s, c o n c e pt s a n d t h e m e s. Tr a n s cri pt s will b e c ar ef ull y 
r e a d a n d c o d e d wit h t h e a s si st a n c e of q u alit ati v e d at a m a n a g e m e nt s oft w ar e, c o n st a ntl y 
c o m p ari n g t h e r e s ult s a g ai n st t h e ori gi n al t e xt f or ri g or. 1 6  Fr o m fi n al c o d e d tr a n s cri pt s, t e xt 
s e g m e nt s will b e a n al y z e d u si n g a c o m p ut ati o n al pr o c e s s of q u er i e s a n d c o m p ari s o n s.  
•   
C o nfi d e nti alit y: All d at a e x c e pt f or t h e c o n s e nt f or m s a n d HI P P A f or m s will b e c o d e d at 
t h e ti m e of d at a r e c or di n g s u c h t h at p er s o n all y i d e ntifi a bl e i nf or m ati o n i s n ot u s e d i n t h e 
d at a r e c or di n g. Q u alit ati v e i nt er vi e w s will n ot h a v e i d e ntifi a bl e i nf or m ati o n s u c h a s 
p arti ci p a nt n a m e s. Vi d e o s of t h e b e h a vi or al h a n d f u n cti o n will b e r e c or d e d s u c h t h at t h e 
h a n d, ar m, a n d o bj e ct b ei n g gr a s p e d will b e i n t h e vi d e o b ut n o t t h e p arti ci p a nt f a c e. All 
el e ctr o ni c d at a will b e st or e d i n a p a s s w or d- pr ot e ct e d r e s e ar c h s er v er t h at i s a c c e s si bl e t o 
st u d y p er s o n n el o nl y. T h e s er v er i s b a c k e d u p e v er y d a y a n d m ai nt ai n e d 2 4/ 7 b y I T 
s p e ci ali st s. All p a p er d at a wit h p er s o n all y i d e ntifi a bl e i nf or m ati o n i n cl u di n g t h e c o n s e nt 
f or m s a n d HI P P A f or m s will b e st or e d i n a k e y-l o c k e d c a bi n et i n a k e y-l o c k e d r o o m t h at i s 
a c c e s si bl e t o st u d y p er s o n n el o nl y. Ot h er p a p er d at a wit h o ut p e r s o n all y i d e ntifi a bl e 
i nf or m ati o n i n cl u di n g t e sti n g s h e et s d o c u m e nti n g t e sti n g s e q u e nc e s a n d n ot e s will al s o b e 
st or e d i n a c a bi n et i n a k e y- l o c k e d r o o m t h at i s a c c e s si bl e t o st u d y p er s o n n el o nl y. 
•   
D at a s h ari n g: D at a will b e s h ar e d wit h c oll a b or ati n g sit e s, M e di c al U ni v er sit y of S o ut h 
C ar oli n a ( M U S C) a n d t h e V A C e ntr ali z e d Tr a n s cri pti o n S er vi c e s Pr o gr a m. D e-i d e ntifi e d 
d at a will b e s h ar e d wit h a n ot h er c oll a b or ati n g sit e, N ort h C ar oli n a St at e U ni v er sit y 
( N C S U). D e-i d e ntifi e d c o d e d d at a will b e r e p ort e d a n d/ or s h ar e d wit h t h e pu bli c a n d ot h er 
i n v e sti g at or s i n p u bli c ati o n s, i n Cli ni c al Tri al s. g o v, or vi a n et w or k st or a g e. 
 
1 3. 0  Pr o vi si o n s t o M o nit or t h e D at a t o E n s ur e t h e S af et y of S u bj e ct s  
•   
T h e pr o p o s e d r e s e ar c h i s a si n gl e- sit e r a n d o mi z e d c o ntr oll e d cli ni c al tri al. A D at a S af et y 
M o nit ori n g B o ar d ( D S M B) will b e u s e d. T h e pri m ar y p ur p o s e of t h e D S M B i s t o e n s ur e t h e 
s af et y of p arti ci p a nt s a n d t h e v ali dit y a n d i nt e grit y of d at a c oll e ct e d d uri n g t h e st u d y. T h e 
o v er all fr a m e w or k i n v ol v e s bi a n n u al r e vi e w of t h e e nr oll m e nt/r et e nti o n, s af et y a n d 
a d v er s e e v e nt d at a, a n d q u alit y c o ntr ol d at a b y t h e D S M B d uri n g t h e t e n ur e of t h e 
pr o p o s e d r e s e ar c h.  

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Pa ge 9 of 1 1  
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D S M B  c o m p o siti o n:  T h e  D S M B  will  b e  c o m p o s e d  of  t hr e e  pr of e s si o n al s  wit h  e x p erti s e 
r el at e d  t o  t h e  pr o p o s e d  ar e a  of  st u d y  w h o  ar e  n ot  i n v ol v e d  wit h  t h e  st u d y  d e si g n  or 
e x p eri m e nt s.  S p e cifi c all y, t h e D S M B will i n cl u d e: ( 1) a b o ar d- c ertifi e d str o k e n e ur ol o gi st 
w h o  al s o  i s  a  str o k e  r e c o v er y  r e s e ar c h er  a n d  i s  e x p eri e n c e d  i n  c ar e  of  c hr o ni c  str o k e 
s ur vi v or s a n d t h eir r e c o v er y; ( 2) a r e gi st er e d a n d li c e n s e d o c c u p ati o n al t h er a pi st w h o al s o 
i s  a  q u a ntit ati v e  r e s e ar c h er  i n  o ut c o m e s  m e a s ur e m e nt  a n d  r e s e ar c h  d e si g n;  a n d  ( 3)  a 
bi o st ati sti ci a n wit h e x p erti s e i n d e si g n a n d a n al y si s of cli ni c al tri al s. T hi s m ulti di s ci pli n ar y 
gr o u p  h a s  e x p eri e n c e  wit h  m a n a g e m e nt  a n d  m o nit ori n g  of  cli ni c al  i nt er v e nti o n  tri al s 
i n v ol vi n g i n di vi d u al s f oll o wi n g str o k e, a n d bri n g s s u b st a nti al e x p erti s e a d e q u at e t o s er v e 
a s t h e D S M B. 
•   
D S M B r e s p o n si biliti e s:  
-  
Pri or t o a n y e nr oll m e nt, t h e D S M B will r e vi e w t h e st u d y d e si g n, pr ot o c ol, i nf or m e d c o n s e nt 
d o c u m e nt s, a m e n d m e nt s, r e cr uit m e nt/ e nr oll m e nt pl a n, st ati sti c al a n al y si s pl a n, a n d d at a 
a n d s af et y m o nit ori n g pl a n, a n d d o c u m e nt t h e a gr e e m e nt or r e c o m m e n d ati o n.  
-  
O n c e t h e e nr oll m e nt b e gi n s, t h e D S M B will c o n v e n e e v er y 6 m o nt h s t o r e vi e w t h e pr o gr e s s 
of t h e tri al.  
-  T h e  D S M B  will  r e vi e w  t h e  e nr oll m e nt/r et e nti o n  d at a  i n cl u di n g  n e w  e nr oll m e nt s, 
pr o gr e s si o n of t h e e nr oll e e s’ p arti ci p ati o n i n t h e st u d y, a n y di s c o nti n u ati o n of p arti ci p ati o n 
i n t h e st u d y wit h or wit h o ut a d v er s e e v e nt s, a n d t h e c urr e nt e nr oll m e nt st at u s c o m p ar e d 
t o t h e pr oj e ct ti m e li n e. 
-  T h e D S M B will r e vi e w d at a q u alit y a n d q u alit y c o ntr ol d at a. 
-  T h e  D S M B  will  r e vi e w  s af et y  a n d  a d v er s e  e v e nt  d at a.  T h e  D S M B  will  r e vi e w  t h e 
a g gr e g at e d s u m m ar y d at a a s w ell a s t h e i n di vi d u al p arti ci p a nt s’ d at a ( c o d e d). T h e D S M B 
will di s c u s s p arti ci p a nt ri s k v s. b e n efit a n d ot h er f a ct or s t h at m a y p ot e nti all y aff e ct st u d y 
o ut c o m e s.  T h e  D S M B  will  m a k e  r e c o m m e n d ati o n s  f or  a p pr o pri at e  a cti o n  t o  m ai nt ai n  a 
r e a s o n a bl e s af et y pr ofil e f or t h e st u d y.  
-  T h e D S M B will e n s ur e t h at all s eri o u s a d v er s e e v e nt s h a v e b e e n f oll o w e d t o r e s ol uti o n, 
a n d t h at t h e a p pr o pri at e a g e n ci e s (i n cl u di n g t h e I R B a n d/ or f e d er al f u n di n g a g e n c y) h a v e 
b e e n i nf or m e d.  
-  T h e  D S M B  will  a d vi s e  t h e  I R B  a n d  t h e  st u d y  i n v e sti g at or s  a s  t o  w h et h er  t h e  pr ot o c ol 
s h o ul d  c o nti n u e  a s  s c h e d ul e d  or  u n d er g o  a n y  m o difi c ati o n  d u e  t o  fi n di n g s  fr o m  t h e 
m o nit ori n g pr o c e s s. T h e D S M B m a y r e c o m m e n d st o p pi n g t h e st u d y e arl y if t h e st u d y h a s 
u n a nti ci p at e d s af et y c o n c er n s t h at w arr a nt st o p pi n g.  
-  T h e D S M B will r e vi e w st u d y p erf or m a n c e a s w ell a s m a k e r e c o m m e n d ati o n s a n d a s si st i n 
r e s ol uti o n of pr o bl e m s r e p ort e d b y t h e PI.  
-  T h e D S M B will e n s ur e t h e c o nfi d e nti alit y of t h e st u d y d at a a n d t h e r e s ult s of m o nit ori n g. 
-  T h e  D S M B  will  d o c u m e nt  t h eir  r e vi e w s  i n  writi n g  a n d  pr o vi d e  a  r e p ort  t o  t h e  I R B  t o 
s u m m ari z e o v er si g ht a cti viti e s, r e c o m m e n d ati o n s a n d a n y c o n c er n s r e g ar di n g p arti ci p a nt 
s af et y.  T h e  r e p ort  will  i n cl u d e  p arti ci p a nt  c h ar a ct eri sti c s  (i n cl u di n g  di stri b uti o n s  a cr o s s 
r a c e a n d s e x), r et e nti o n a n d di s p o siti o n of st u d y p arti ci p a nt s, q u alit y a s s ur a n c e i s s u e s a n d 
r e p ort s  of  a d v er s e  e v e nt s,  si g nifi c a nt/ u n e x p e ct e d  a d v er s e  e v e nt s  a n d  s eri o u s  a d v er s e 
e v e nt s.  
-  T h e D S M B will r e vi e w fi n al a n al y si s r e s ult s u p o n c o m pl eti o n of t h e d at a c oll e cti o n. 
•   
R e p orti n g of s af et y d at a: All s eri o u s a d v er s e e v e nt s will b e r e p ort e d t o t h e I R B a s t h e y 
o c c ur. All e nr oll m e nt/r et e nti o n d at a, a n d s af et y a n d a d v er s e e v e nt d at a will b e r e p ort e d t o 
t h e D S M B d uri n g t h e r e vi e w. T h e D S M B will r e vi e w t h e d at a a n d s u b mit a r e p ort t o t h e 
I R B. S u m m ati v e s af et y d at a will b e r e p ort e d t o V A R e s e ar c h S er vi c e s, Cli ni c al Tri al s. g o v, 
a n d i n p u bli c ati o n s. A s s u c h, w e will r e gi st er t hi s st u d y i n Cli ni c al Tri al s. g o v a s s o o n a s t h e 
st u d y c o m m e n c e s a n d r e p ort r e s ult s i n cl u di n g all a d v er s e e v e nt s a s s o o n a s t h e st u d y i s 
c o m pl et e d  f oll o wi n g  t h e  g ui d eli n e s.  T o  pr ot e ct  p arti ci p a nt s’  c o nfi d e nti alit y,  p er s o n all y 

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Pa ge 1 0 of 1 1  
i d e ntifi a bl e i nf or m ati o n will n ot b e u s e d f or r e p orti n g. O nl y d e-i d e ntifi e d or a g gr e g at e d d at a 
will b e u s e d f or r e p orti n g.  
 
1 4. 0  
Wit h dr a w al of S u bj e ct s  
•   
S u bj e ct s w h o d o n ot s h o w u p o n s c h e d ul e d vi sit s or d o n ot c o m pl et e t h e i nt er v e nti o n i n 1 0 
w e e k s  m a y  b e  wit h dr a w n  b y  t h e  i n v e sti g at or.  S u bj e ct s  w h o  ar e  or  b e c o m e  m e di c all y 
u n st a bl e m a y b e wit h dr a w n b y t h e i n v e sti g at or. 
•   
F or t h o s e w h o wit h dr a w fr o m t h e r e s e ar c h, t h eir d at a c oll e ct e d u p t o t h at p oi nt m a y b e 
u s e d b y t h e i n v e sti g at or.    
 
1 5. 0  Ri s k s t o S u bj e ct s 
T h er e i s a sli g ht ri s k f or l o s s of c o nfi d e nti alit y alt h o u g h r e s e ar c h er s will t a k e a p pr o pri at e st e p s 
t o pr ot e ct a n y i nf or m ati o n c oll e ct e d a b o ut t h e p arti ci p a nt s. T her e i s a mi n or ri s k of p h y si c al a n d 
m e nt al f ati g u e fr o m e n g a gi n g i n t h e st u d y a cti vit y. T h er e i s a mi n or ri s k of di s c o mf ort fr o m 
h a vi n g m u s cl e a cti vit y s e n s or s or j oi nt p o siti o n s e n s or s d uri n g  h a n d m o v e m e nt d uri n g t h e 
b e h a vi or al h a n d f u n cti o n a s s e s s m e nt. T h er e i s a mi n or ri s k of s ki n irrit ati o n fr o m a d h e si v e s 
u s e d t o affi x m u s cl e a cti vit y s e n s or s or j oi nt p o siti o n s e n s or s d uri n g t h e b e h a vi or al h a n d 
f u n cti o n a s s e s s m e nt. T h er e i s a ri s k of f all fr o m st a n di n g or w al ki n g, alt h o u g h s u bj e ct s will b e 
w e ari n g a w h ol e b o d y h ar n e s s t o pr e v e nt s u c h e v e nt s. T h e tr e at m e nt o n e p er s o n r e c ei v e s m a y 
pr o v e t o b e l e s s eff e cti v e or t o h a v e m or e si d e eff e ct s t h a n t h e ot h er st u d y tr e at m e nt. T h e 
e x p eri m e nt al tr e at m e nt s m a y h a v e u n k n o w n si d e eff e ct s. 
 
1 6. 0  P ot e nti al B e n efit s t o S u bj e ct s or Ot h er s 
T h er e m a y b e n o b e n efit fr o m p arti ci p ati n g i n t hi s st u d y. T h e p ot e nti al b e n efit  i s t h at t h e tr ai ni n g 
t h e p arti ci p a nt r e c ei v e s m a y h el p r e c o v er t h eir h a n d f u n cti o n, alt h o u g h t hi s c a n n ot b e 
g u ar a nt e e d. T h e k n o wl e d g e r e g ar di n g t h e m erit of f or c e tr ai ni n g  i s i m p ort a nt t o cr e at e a n e w 
t h er a p y o pti o n f or p e o pl e w h o h a d a str o k e a n d m a y b e n efit str ok e s ur vi v or s i n g e n er al. T h e 
ri s k s ar e d e e m e d r e a s o n a bl e i n r el ati o n t o t h e p ot e nti al g ai n of k n o wl e d g e r e g ar di n g t h e eff e ct 
of n o v el f or c e tr ai ni n g i n e n h a n ci n g h a n d f or c e c o ntr ol a n d h a n d f u n cti o n aft er str o k e. 
 
1 7. 0  S h ari n g of R e s ult s wit h S u bj e ct s 
If  t h e  s u bj e ct  a gr e e s,  t h e  d at a  c oll e ct e d  a n d  g e n er at e d  fr o m  t hi s  st u d y  will  b e  s h ar e d  t o  t h e 
R e gi str y f or Str o k e R e c o v er y ( R E S T O R E- Pr o # 0 0 0 3 7 8 0 3) b y t h e s u bj e ct’ s r e gi str y I D. S h ari n g 
d at a fr o m t hi s st u d y wit h t h e r e gi str y will all o w f or m or e t ar g et e d r e cr uit m e nt eff ort s i n t h e f ut ur e 
a n d  all o w  r e s e ar c h er s  at  M U S C  t o  h a v e  a  m or e  c o m pl et e  r e gi str y  wit h  k e y  str o k e  r e c o v er y 
el e m e nt s  i n cl u di n g  c o m m o n  d at a  a n d  p h y si c al  f u n cti o n  c h ar a ct eri sti c s  t h at  ar e  a p pli c a bl e  t o 
m ulti pl e st u di e s. M U S C r e s e ar c h er s a n d c oll a b or ati n g f a ciliti e s will b e a bl e t o q u er y d at a s et s t o 
l e ar n m or e a b o ut r e c o v er y of s u bj e ct s aft er t h eir str o k e t hr o u g h i n stit uti o n all y m a n a g e d s e c ur e 
s er v er s t h at will a s s ur e HI P A A pri v a c y a n d s e c urit y c o m pli a n c e. 
 

Version #10; Version Date 6/23/2022 
 
 
 
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