Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation
Phase: NA
Conditions: Stroke
Sponsor: University of South Florida

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9 
Pr ot oc ol f or “ Acti ve Li m b Ort h osis f or H o me Use- Str o ke He mi paretic Gait Re ha bilitati o n” 
Versi o n 5, A pril 8, 2 0 1 9 
PI: 
• La ure n Ras hf or d, D P T ( 3 1 5- 3 3 5- 9 6 2 2)
Me dical M o nit or: 
• Je n na Br o w n, M D ( 8 6 4- 6 4 1- 5 4 1 5)
S p o ns or a d dress: 
M oter u m Tec h n ol o gies I nc. 
5 1 7- A W. N ort h 3 r d Street
Se neca, S C 2 9 6 7 8
3 1 5- 3 3 5- 9 6 2 2
la ure n @ m oter u mtec h n ol o gies.c o m
Researc h site a d dress: ( H o me Trial) 
5 1 7- A W. N ort h 3 r d Street
Se neca, S C 2 9 6 7 8
Rati o nale f or t he st u d y, area of c urre nt scie ntific c o ncer n, a n d w h y  t he researc h is nee de d 
He mi paresis a n d ot her i m pair me nts are a fre q ue nt  a n d disa bli n g c o nse q ue nce of str o ke a n d ca n 
lea d t o as y m metric a n d i nefficie nt wal ki n g patter ns. Trai ni n g o n a s plit- belt trea d mill, w hic h has t w o 
se parate  trea ds  dri vi n g  eac h  le g  at  a  differe nt  s pee d,  ca n  c orrect  gait  as y m metries  p ost-str o ke. 1, 2 
H o we ver, t he effects of s plit- belt trea d mill trai ni n g o nl y partiall y tra nsfer t o e ver y da y wal ki n g o ver 
gr o u n d a n d e xte n de d trai ni n g sessi o ns are re q uire d t o ac hie ve l o n g-lasti n g effects. 3 O ur pre vi o us 
st u dies s u g gest t hat o ur de vice, e ntitle d t he i Stri de T M  Gait S ol uti o n, w hic h has bee n de vel o pe d i n o ur 
la b orat or y ca n be use d as a n alter nati ve gait treat me nt de vice f or pe o ple wit h str o ke 4- 7. T he i Stri deT M  
Gait S ol uti o n ( Fi g ure 1) mi mics t he acti o ns of t h e s plit- belt trea d mill b ut ca n be use d d uri n g o ver-
gr o u n d wal ki n g a n d i n o ne’s o w n h o me, t h us e na b li n g l o n g-ter m treat me nt. T his de vice d oes n ot 
re q uire a n y e xter nal p o wer a n d is c o m pletel y passi ve; all necessar y f orces are re directe d fr o m t h e 
nat ural f orces prese nt d uri n g wal ki n g si nce it utilizes t he wearer’s wei g ht t o ge nerate its m o v e me nts. 
T he res ults of o ur past- p u blis he d a n d c o m plete d st u dies de m o nstrate t hat t he de vice be neficiall y a n d 
a p pr o priatel y  c ha n ges  gait  patter ns,  b ot h  i n  i n di vi d uals  wit h  a  str o ke  a n d  i n  healt h y  i n di vi d uals. 
F urt her m ore,  a  f oll o w- u p  st u d y  ( WI R B  pr ot oc ol  2 0 1 4 0 9 1 5)  of  s u bjects  wit h  c hr o nic  str o ke  was  
c o n d ucte d i n partici pa nt’s h o me e n vir o n me nts a n d s u per vise d b y lice nse d p h ysical t hera pists. T h e 
res ults  de m o nstrate d  t he  safet y  of  i Stri deT M  usa ge  at  h o me  a n d  yiel de d  cli nicall y  si g nifica nt  
i m pr o ve me nts i n gait s pee d a n d fall ris k. T he pr op ose d e x peri me nts descri be d bel o w will f urt her 
e xa mi ne  t he  e xte nt  t hat  i n di vi d uals  wit h  a  str o ke  ca n  i ncrease  t heir  gait  vel ocit y,  i m pr o ve  t heir  
bala nce (t heref ore re d uci n g fall ris k), a n d a da pt i n terli m b c o or di nati o n after weari n g t he de vice. T he 
g oals are t o better u n dersta n d t he effecti ve ness of t h e de vice a m o n g i n di vi d uals wit h str o ke a n d t o 
deter mi ne if usi n g t he de vice at h o me wit h care gi v er s u per visi o n a n d tele me dici ne m o dalities f or 
c o m m u nicati o n will res ult i n t he sa me o utc o me(s) as de vice usa ge b ot h i n t he cli nic a n d i n- h o me 
setti n gs w here p h ysical t hera pists were prese nt at all ti mes.  
I n t his st u d y, we will c o nti n ue t o test t he efficac y of t he de vice o n i n di vi d uals wit h str o ke i n t heir 
h o me e n vir o n me nt. Efficac y will be e val uate d base d o n t he c ha n ge i n gait c o or di nati o n as well as 
ot her gait a n d m o bilit y para meters i ncl u di n g gait s p ee d, bala nce, a n d fall ris k. T his st u d y will als o 
i nte grate m oti o n se ns or tec h n ol o g y i n or der t o o btai n real-ti me data, e. g. gait a nal ysis.  We pre dict 
t hat t he de vice will c o nti n ue t o de m o nstrate c ha n g es t o i nterli m b c o or di nati o n of gait as well as 
i m pr o ve me nt i n gait a n d m o bilit y para meters. 
2 0 1 4 0 9 1 5
I R B A p pr o ve d at t he 
Pr ot oc ol Le vel 
A pr 2 3, 2 0 1 9
20140915
IRB Approved at the 
Protocol Level 
Apr 23, 2019

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9
Fi g ure 1: Pic t ure of de vice – n ote t hat w heels ar e desi g ne d s uc h t hat d o w n war d f orce (i.e. fr o m 
sta n di n g) will ca use t he m t o r otate a n d m o ve t he s h oe bac k war ds, relati ve t o t he gr o u n d. ( b ott o m) 
T he m oti o n of t he de vice fr o m heel c o ntact u ntil t oe off of wal ki n g. T he de vice was meas ure d t o 
ha ve a s m o ot h h oriz o ntal bac k war d m oti o n of a p pr o xi matel y 6- 8” ( 1 5- 2 0 c m). 
1.
Bac k gr o u n d i nf or mati o n, descri pti o n of e xisti n g researc h, a n d i nf or mati o n t hat is alrea d y k n o w n
I n t he U nite d States, nearl y 8 0 0, 0 0 0 pe o ple s uffer a str o ke eac h y ear, a n d a p pr o xi matel y t w o-
t hir ds  of  t hese  i n di vi d uals  s ur vi ve8.  Ma n y  pe o ple  s uffer  fr o m  si g nifica nt  a n d  l o n g-lasti n g  m ot or
deficits t hat re q uire re ha bilitati o n. O ne s uc h m ot or de ficit t hat fre q ue ntl y occ urs is he mi paresis, or a
wea k ness o n o ne si de. A m o n g isc he mic str o ke s ur vi v ors o ver 6 5 years ol d, half ha d s o me de grees of
he mi paresis persisti n g si x m o nt hs p ost-str o ke. 9 L o wer li m b he mi paresis lea ds t o as y m metric wal ki n g
patter ns, calle d he mi paretic gait. 1 0, 1 1 S pecific c haracteristics of he mi paretic gait i ncl u de as y m metries
i n te m p oral (e. g. s wi n g ti me a n d d o u ble-s u p p ort ti me)1 0, 1 2 a n d s patial (e. g. ste p le n gt h)1 3 meas ures of
i nterli m b c o or di nati o n. T hat is, t he ti mi n g a n d place me nt of t he feet are n ot e q ual o n t he t w o si des.
T he as y m metric nat ure of he mi paretic g ait ca n ha ve a lar ge i m pact o n f u ncti o nal wal ki n g a bilit y.
F or e xa m ple, s wi n g p hase as y m metr y is a si g nifica nt pre dict or of he mi paretic wal ki n g perf or ma nce
beca use it str o n gl y c orrelates wit h sta g es of m ot or rec o ver y, wal ki n g s pee d, a n d falls. 1 0, 1 2 A n ot her
meas ure of te m p oral as y m metr y – d o u ble s u p p ort d ur ati o n – is si milarl y c orrelate d wit h wal ki n g
s pee d. 1 4 I n a d diti o n, s patial (e. g. ste p le n gt h) as y m metr y is ass ociate d wit h decrease d pr o p ulsi ve f orce
o n t he paretic le g, 1 3, 1 5 w hic h li mits f or war d m oti o n of t he b o d y a n d re d uces gait efficie nc y 1 6, 1 7. T he
i m p orta nce of gait efficie n c y s h o ul d n ot be u n derstated – t he ele vate d e ner g y de ma n ds of he mi paretic
gait c o m bi ne d wit h p h ysical dec o n diti o ni n g p ost-str o ke ca n greatl y li mit perf or ma nce of acti vities of
dail y li vi n g, c o ntri b uti n g t o p o or car di o vasc ular fi t ness a n d meta b olic s y n dr o me. I n t ur n, t his ca n
i ncrease  t he  ris ks  of  a  sec o n d  str o ke  or  car di o vasc ular  e ve nt  a n d  is  ass o ciate d  wit h  i ncrease d
m or bi dit y a n d m ortalit y rates. 1 8 T heref ore, i m pr o vi n g gait s y m metr y s h o ul d be a n i m p orta nt g oal f or
t hera p y, t o n ot o nl y i m pr o ve f u ncti o nal m o bilit y a n d re d uce i nj ur y, b ut als o t o e n ha nce ge neral healt h
a n d well- bei n g p ost-str o ke.
Practici n g wal ki n g o n a s plit- belt trea d mill ca n c orr ect a b n or mal i nterli m b co or di nati o n of gait i n
i n di vid uals wit h he mi paresis f oll o wi n g str o ke  or ot her ce ntral ner v o us s yste m lesi o ns1, 2. As y m metric
gait ca n ma nifest as a s patial as y m me tr y, i n w hic h ste ps ta ke n o n o ne si de are l o n ger t ha n t h ose o n
t he ot her. It ca n als o ma nifest as a te m p oral as y m metr y, w here t he ti mi n g is u ne ve n o n t he paretic a n d
n o n- paretic si des. Te m p oral as y m metries are ofte n meas ure d as differe nces i n t he d urati o n of d o u ble
s u p p ort peri o ds, w hic h are t he a m o u nt of ti me b ot h feet are si m ulta ne o usl y c o ntacti n g t he gr o u n d a n d
are meas ure d se paratel y f or t he paretic a n d n o n- paretic  si des. T he de vice is desi g ne d t o ca use c ha n ges
i n b ot h s patial a n d te m p oral gait s y m metr y. We pre dict t hat t he de vice w o ul d ca use t he ste ps o n t he

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9 
si de wit h t he de vice t o be lar ger si nce i n di vi d uals w o ul d c o m pe nsate f or t he bac k war d r olli n g m oti o n 
b y placi n g t heir f o ot fart h er f or war d i n sta nce, t h us i ncreasi n g t he dista nce bet wee n t he t w o feet. 
Si milarl y, si nce t he stri de is l o n ger, it ma y als o s h orte n t he d urati o n of sta nce relati ve t o t he ot her 
si de. Wit h s h orte ne d sta nce d urati o n, t he a m o u nt of ti me s pe nt i n d o u ble-s u p p ort at t he e n d of sta nce 
w o ul d li kel y decrease as well.  
Alt h o u g h t he ori gi nal i dea of t he de vice is deri ve d fr o m t he m oti o n of t he s plit- belt-trea d mill, 
t here are disti nct differe nce bet wee n wal ki n g o n t he de vice a n d wal ki n g o n a s plit- belt trea d mill wit h 
as y m metric  belt  vel ocities. 5 W hile  t he  b o d y’s  vel ocit y  relati v e  t o  gr o u n d  is  zer o  o n  a  s plit- belt  
trea d mill, t he relati ve vel o cit y of t he de vice is n o n-zer o a n d f or war d. T he de vice f orces t he wearer’s 
f o ot f or war d or bac k war d w hereas t he trea d mill mo ves b ot h feet bac k war d, b ut at differe nt s pee ds. 
F or b ot h t he s plit- belt trea d mill a n d t he de vice, t he re lati ve vel ocit y bet wee n b ot h feet is si milar a n d 
t he bac k war d- m o vi n g de vice ta kes t he place of t he faster trea d. O ur st u d y will e xa mi ne h o w t he 
m oti o n of t he s h oe affects t he c ha n ge i n gait. 
After fi nalizi n g o ur preli mi nar y res ults ( WI R B pr ot oc ol 2 0 1 4 0 9 1 5), we ha ve de m o nstrate d t hat 
treat me nt  o ver  gr o u n d  will  lea d  t o  a  c ha n ge  i n  t he  i nterli m b  c o or di nati o n  i n  i n di vi d uals  wit h  
as y m metric gait a n d all o w i n di vi d uals  t o de vel o p a m ore persiste nt s y m metric gait. T here are se veral 
differe nces  b et wee n  treat me nt  o ver  gr o u n d  a n d  a  trea d mill,  s uc h  as  vis ual  fl o w  a n d  vesti b ular  
i nf or mati o n si g nali n g f or war d m o ve me nt t hat li kel y li mit t he e x pressi o n of lear ni n g i n t he o ver-
gr o u n d  c o nte xt  w he n  trai ne d  o n  a  trea d mill.  Vis u al  c ues  a p pear  t o  be  partic ularl y  i m p orta nt  f or  
c o nte xt  a ware ness. 1 9 Vis ual  c ues,  c o u ple d  wit h  pri or  e x pe rie nce,  are  s o  p o werf ul  t hat  pre dicti ve  
p ost ural res p o nses ca use a n i n di vi d ual t o st u m ble w he n  ste p pi n g o nt o a n escalat or t hat is n ot m o vi n g 
2 0, 2 1. T he b o d y has lear ne d a n i nter nal m o del t hat e x pects a n accelerati o n w he n ste p pi n g o nt o a n 
escalat or, b ut w he n t hat accelerati o n d oes n ot occ ur,  t he pers o n st u m bles. A rece nt st u d y of s plit- belt 
wal ki n g  s h o we d  t hat  tra nsfer  t o  o ver- gr o u n d  wal k i n g  is  e n ha nce d  w he n  s u bjects  are  bli n df ol de d  
d uri n g treat me nt o n t he trea d mill a n d teste d o ver gr o u n d. 2 2 Si nce bli n df ol di n g eli mi nates vis ual c ues 
a b o ut  t he  e n vir o n me nt,  t his  als o  s u g gests  t hat  visi o n  is  a  ke y  fact or  i n  deter mi ni n g  t he  c o nte xt-
de pe n de nce of lear ni n g. Si nce it is n ot realistic t o  bli n df ol d str o ke patie nts d uri n g gait treat me nt, we 
desi g ne d t he i Stri de T M  Gait S ol uti o n s o t hat treat me nt c o ul d occ ur d uri n g o ver- gr o u n d wal ki n g, t h us 
vis ual c ues d uri n g treat me nt a n d later wal ki n g o ver gr o u n d w o ul d be t he sa me. 
Data fr o m c o ntr ol s u bjects usi n g a n earlier versi o n of t he de vice has bee n p u blis he d 4 a n d a vi de o 
of
 t his
 pre vi o us
 versi o n
 ca n
 be
 f o u n d
 at
htt p://ree dla b. e n g. usf.e d u/ p u blica ti o ns/ ha n dzic 2 0 1 1 G E M S. m p 4.  I n  t his st u d y,  we  f o u n d  t hat  t his  
earlier versi o n of t he de vice was ca p a ble of c ha n gi n g ste p le n gt h as pre dicte d, h o we ver t he pre vi o us 
desi g n was t o o hea v y a n d t o o tall t o be c o nsi dere d  practical f or testi n g i n str o ke p o p ulati o ns. T he 
c urre nt versi o n of t he de vice pr o d uces si milar m oti o n t o t he pre vi o us versi o n, b ut it wei g hs less ( ~ 1 
k g) a n d is s h orter ( ~ 4. 4 c m). O ur m ost rece nt st u d y ( WI R B pr ot oc ol 2 0 1 4 0 9 1 5) teste d t he efficac y of 
weari n g t he c urre nt de vice o n gait c o or di nati o n d ur i n g wal ki n g o ver gr o u n d wit h i n di vi d uals p ost-
str o ke, w hic h t o o k place i n t he partici pa nts’ h o me e n vir o n me nts.  
O ur i Stri de T M Gait S ol uti o n re prese nts o ne of t he first atte m pts t o b uil d a de vice t hat c orrects 
wal ki n g s y m metr y w hile wal ki n g o ver gr o u n d. N ot o nl y w o ul d t his all o w pe o ple t o e x perie nce gait 
c orrecti o ns w hile perf or mi n g n or mal m o ve me nts, b ut  t he si m plicit y a n d relati ve l o w c ost of t hese 
de vices w o ul d als o o pe n u p p ote ntial o p p ort u nities t o trai n at h o me (f or hi g h-f u ncti o ni n g i n di vi d uals 
wit h s u per visi o n) a n d i n cli nics w here a s plit- belt trea d mill is n ot a vaila ble. T he st u dies o utli ne d here 
will  c o nti n ue  t o  esta blis h  w het her  t he  de vice  is  ca pa ble  of  c h a n gi n g  i nte rli m b  c o or di nati o n  a n d  
para meters of gait (i ncl u di n g gait s pee d a n d bala nce), a n d w het her i n di vi d uals wit h str o ke ca n safel y 
use  t hese  de vices  f or  re ha bilitati o n  p ur p oses  i n  t he  h o me  e n vir o n me nt  wit h  s u per visi o n  of  t heir  
care gi ver a n d i nter mitte nt f oll o w- u p b y a p h ysical t her a pist. T his w or k will t h us b uil d t he f o u n dati o n 
f or f ut ure st u dies e xa mi ni n g t he effecti ve ness of l o n g-ter m use of t he de vice f or i m pr o vi n g wal ki n g 
perf or ma nce i n i n di vi d uals wit h he mi paresis fr o m str o ke. 
 
After i nitiall y assessi n g t he a bilit y of t he i Stri de T M  de vice t o c ha n ge gait para meters of str o ke 
s ur vi v ors i n t he cli nic setti n g, we s u bseq ue ntl y st u die d t he safet y a n d efficac y of its  usa ge i n t he 

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9
h o me e n vir o n me nt u n der t he s u per visi o n of lice nse d p h ysical t hera pists. I n t his st u d y, we c ollecte d 
data  fr o m  1 5  s u bjects  wit h  c hr o nic  str o ke  w h o  trai ne d  o n  t he  i Stri de T M  de vice  i n  t heir  h o me  
e n vir o n me nt. P h ysi ol o g se ns ors were use d o n eac h s u bject d uri n g e ver y sessi o n. Se ns or data has 
bee n use d t o calc ulate t he t otal ste ps eac h user t o o k, w hic h has bee n use d t o deter mi ne t he a vera g e 
n u m ber  of  ste ps  per  user  as  well  as  t he  a vera g e  n u m ber  of  wal ki n g  sessi o ns.   T he  calc ulate d  
a vera ges of ste ps per user a n d a vera ge wal ki n g sessi o ns per user are 7, 8 1 7 a n d 5 5, res pecti vel y. 
T hese a vera g es were use d t o calc ula te t he t otal ste ps f or t he 1 5 users w h ose e ve nts are descri be d 
here.  Ta ble 1 pr o vi des rele va nt usa ge data. 
Ta ble 1. 
N u m ber of Users 
T otal N u m ber of Ste ps o n 
i Stri de de vice 
T otal  n u m ber  of  wal ki n g  
sessi o ns  o n  t he  i Stri de T M  
De vice 
1 5
1 1 8, 0 0 0
8 2 2
T his pr ot oc ol re q uire d a lice nse d p h ysical t hera pist t o be prese nt at all times d uri n g eac h visit.  All 
t hera pists were re q uire d t o d oc u me nt S O A P n otes ( S u bjecti ve, O bjecti ve, Assess me nt, a n d Pla n) f or 
eac h sessi o n wit h t he patie nt.  T he y were als o  re q uire d t o d oc u me nt a n y i nsta nces w here ha n ds- o n 
p h ysical assista nce or c o ntact was re q uire d w hile treati n g wit h t he i Stri de T M  de vice.  W e will refer t o 
t his p h ysical or ha n ds- o n assista nce as “i nter ve nti ons.”  I n assessi n g t he acti vities of t he t hera pists 
wit h t he patie nts t he F u ncti o nal I n de pe n de nce M eas ure ( FI M) assista nce le vels were d oc u me nte d. 2 3 
Ta ble 2 s h o ws t he t otal n u m b er of re q uire d assista nce i nter ve nti o ns d uri n g t he 1 5 users’ ti me o n t he 
de vice 
Ta ble 2 
Wee ks
I nter ve nti o n
Wee k 1 ( Visits 1- 3) 
1 6 ( wit h 1 4 o ut of 1 6 occ urri n g at sessi o n 1) 
Wee k 2 ( Visits 4- 6) 
2 
Wee k 3 ( Visits 7- 9) 
3 
Wee k 4 ( Visits 1 0- 1 2) 
1 (sit t o sta n d tra nsfer) 
T here were a t otal of 2 2 “i nter ve nti o ns” nee d e d  d uri n g t he 1 1 8,0 0 0 ste ps ta ke n. D uri n g t he first 
treat me nt sessi o n, 1 4 i nter ve nti o ns occ urre d d uri n g a p pr o xi matel y 1 0, 7 0 5 ste ps o n t he i Stri deT M  
de vice. T his a m o u nts t o 1 i nter ve nti o n per 7 6 5 ste ps.  I n c o ntrast, after t he first sessi o n t here was 1 
i nter ve nti o n nee de d per 1 3, 3 1 9 ste ps or a p pr o xi matel y 0. 5 i nter ve nti o ns per m o nt h of acti vit y per 
patie nt. T he data dis pla y e d i n Ta ble 2 clearl y s h o w s t hat t he nee d f or i nter ve nti o n fr o m t he p h ysical 
t hera pist was mi ni mal o nce users beca me acc ust o me d t o t he de vice.  
A nal y zi n g t he t y pe of assista nce f urt her s h o we d  t hat n o i nter ve nti o n wit h a patie nt re q uire d 
m ore t ha n Mi ni mal Assist at a n y p oi nt d uri n g treat me nt wit h t h e i Stri de
T M  s yste m. Mi ni mal assist 
ca n be defi ne d as p h ysical hel p fr o m a n ot her pers o n w hile t he s u bject e x pe n ds 7 5 % or m ore of t he 

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9 
eff ort. 2 3 D uri n g t he f o ur wee ks of i Stri deT M  treat me nt, o nl y o ne a d verse e ve nt was rec or de d.  D uri n g 
t his e ve nt, t he patie nt be ga n t o feel dizz y w hile wal ki n g a n d t heref ore ha d a c o ntr olle d fall t o t he 
c hair. T he patie nt was n ot i nj ure d.  Of n ote, t his i n di vi d ual ha d a sec o n dar y ata xia i n a d diti o n t o t heir 
str o ke he mi p aresis.  
  T hese res ults clearl y s h o w t hat after t he first sessi o n, t here is a ver y l o w li keli h o o d t hat a n y 
i nter ve nti o n fr o m t he p h ysical t hera pist is necessar y a n d e ve n less li keli h o o d t hat i nter ve nti o n t o 
pre ve nt  a n  act ual  fall  w o ul d  be  nee de d.   As  s u c h,  t he  necessit y  of  f ull-ti me  p h ysical  t hera pist  
s u per visi o n ma y be q uesti o ne d a n d f urt her i n vesti gate d. 
2.
T he resear c h q uesti o ns, o bjecti ves, a n d p ur p ose
T he q uesti o n t hat t his st u d y tar gets is t he m o dificati o n of h u ma n wal ki n g patter ns f or use i n
str o ke re ha bilitati o n. It is o ur ulti mate o bjecti ve t o s h o w t hat t he de vice ca n c ha n ge a pers o n’s
te m p oral a n d s patial gait as y m metr y i nt o a s y m metric gait as well as i m pr o ve ot her gait a n d m o bilit y
para meters i ncl u di n g gait s pee d a n d bala nce. O ur p oi nt s of refere nce are res ults o btai ne d b y pre vi o us
st u dies wit h s plit- belt trea d mills, a n d data o btai ne d fr o m o ur pre vi o us cli nic a n d h o me st u d y trials
wit h  t he  i Stri de T M  de vice.  A d diti o nall y,  gi ve n  t he  mi ni ma l  i nter ve nti o ns  nee de d  b y  s u per visi n g
p h ysical  t hera pists  d uri n g  o ur  i nitial  h o me  st u d y,  we  are  i ntereste d  i n  assessi n g  t he  c o nti n ue d
efficac y a n d safet y of t he de vice wit h t he s u bject’s  care gi vers pr o vi di n g su per visi o n a n d i nter mitte nt
(i nstea d of f ull-ti me) f oll o w- u p of t he p h ysical t hera pist.
3.
T he st u d y desi g n i ncl u di n g i nf or mati o n t hat is  nee de d t o a ns wer t he researc h q uesti o ns
T he g oal of t his st u d y is t o test t he efficac y, safet y, a n d feasi bilit y of t he i Stri de T M  de vice t o
c orrect gait as y m metr y a n d i m pr o ve gait para meters i ncl u di n g gait s pee d a n d bala nce i n i n di vi d uals
wit h str o ke. T he st u d y  will be str uct ure d ar o u n d s u bjects wal ki n g o n t he device wit h t heir gait
rec or de d a n d a nal yze d bef ore a n d after de vice u sa ge. T he st u d y desi g n is wit hi n-s u bjects w here eac h
i n di vi d ual’s gait will be c o m pare d bef ore, d uri n g, a n d after t he treat me nt peri o d. T he st u d y will be
c o n d ucte d o n c hr o nic str o ke patie nts i n a h o me- base d setti n g.  T he treat me nt will last at least f o ur
wee ks wit h a n i nitial visit pri or t o t he start of tr eat me nt a n d se veral f oll o w- u p tests tar get e d at o ne
m o nt h, t hree m o nt hs, si x m o nt hs a n d t wel ve m o nt hs  p ost-treat me nt, i n or der t o meas ure rete nti o n. A
s u bset of t he h o me st u d y patie nts ma y be as ke d t o c o nti n ue treat me nt wit h variati o ns i n fre q ue nc y
a n d d urati o n. I n a d diti o n, se veral c ust o mizati o n fact ors, s pecificall y t o t he w h eel size, ma y be teste d
i n or der t o deter mi ne if patie nts platea u at a n y p oi nt d uri n g t heir re ha bilitati o n. T his is i m p orta nt i n
or der t o deter mi ne t he m ost be neficial prescri pti o n f or patie nts w hile usi n g t he de vice.  A d diti o nall y,
i n or der to assess m uscle acti vati o n a n d res p o nse, a s u bset of t hese s u bjects ma y be as ke d t o visit a n
alter nate cli ni c site f or E M G testi n g pre a n d p ost-treat me nt.
T he h o me- base d treat me nt will c o nsist of at l east t wel ve treat me nt sessi o ns perf or me d o ver a
mi ni m u m of f o ur wee ks wit h a gait e val uati o n pretest a n d i nitial fitti n g of t he s h oe t he wee k bef ore.
Gait  e val uati o ns  will  be  perf or me d  t he  wee k  bef o re  t he  first  treat me nt  a n d  peri o dicall y  d uri n g
treat me nt ( n o m ore t ha n o nce per wee k). F oll o w- u p tests will be tar gete d at o ne wee k, o ne, t hree,
si x, a n d t wel ve m o nt hs after t he fi nal treat me nt sessi o n.
D uri n g t he treat me nt, t he lice nse d p h ysical t hera pist will deter mi ne, base d o n eli gi bilit y, if t he
partici pa nt ca n use t he de vice wit h t heir care gi ver  pr o vi di n g s u per visi o n ( wit h o ut t he prese nce of t h e
p h ysical t hera pist eac h sessi o n). T o pr o m ote c o nti n ue d safet y, t he care gi ver w o ul d be re q uire d t o
partici pate i n a treat me nt sessi o n o n t he de vice a n d w o ul d nee d t o de m o nstrate a de q uate k n o wle d ge
of de vice usa ge as well as h o w t o wal k wit h t he partici pa nt safel y. T he t hera pist w o ul d ha ve wee kl y
or  m o nt hl y  f oll o w- u p  visits  t o  m o nit or  c o nti n ue d  safet y,  pr ot oc ol  a d here nce,  a n d  pr o gress.
A d diti o nall y, t he partici pa nt ma y c o m m u nicate s o me  or all sessi o ns wit h a lice nse d t hera pist via
tele me dici ne vi de o c o nfere nci n g usi n g t he 9zest di gital healt h re ha b platf or m ( htt ps:// 9zest.c o m ).
T his  c o m m u nicati o n  ma y  be  use d  t o  e n ha nce  c o m m u nicati o n  wit h  t he  p h ysical  t hera pist.  T his
tele me dici ne m o dalit y is verifie d HI P P A c o m plia nt.

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9
A cr oss o ver c o m p o ne nt ma y als o be e m pl o y e d, i n w hic h a n e q u al n u m ber of treat me nt sessi o ns 
will be d u plicate d wit h o ut t he de vice, bef ore or after t he de vice treat me nt. I n a st u d y of t his t y pe, t he 
patie nts will ha ve a n e q ual n u m ber of sessi o ns of treat me nt wit h o ut t he de vice, i n t he setti n g a n d i n 
t he wa y t he treat me nt will occ ur wit h t he de vice. (e. g. at h o me wit h care gi ver s u per visi o n a n d a 
p h ysical t hera pist i nter mitte ntl y f oll o wi n g- u p).   
T he treat me nt sessi o ns will c o nsist of a p pr o xi matel y 3 0 mi n utes of treat me nt o n t he de vice. T he 
treat me nt  d urati o n  will  be  di vi de d  i nt o  u p  t o  six  s h orter  b o uts  of  wal ki n g  t o  all o w  rest  brea ks  
bet wee n  wal ki n g  sessi o ns,  if  nee de d.   A d diti o na l  brea ks  will  be  gi ve n  as  nee de d  u p o n  s u bject  
re q uest.  Base d o n t he pre-treat me nt gait a nal ysis, we will e val uate all para meters (s uc h as wal ki n g 
s pee d, d o u ble li m b s u p p ort, sta nce time, etc) a n d ma ke a decisi o n t o ma xi mize t heir rec o ver y i n 
re gar d t o w hic h f o ot t he de vice will be place d o n.  T he de vice will e nc o ura ge t he m t o ta k e lar ger 
ste ps wit h t hat f o ot. T he t otal treat me nt sessi o ns will be n o l o n ger t ha n o ne h o ur.  
A st u d y p h ysicia n or a n a d va nce d re gistere d n urse practiti o ner ( A R N P), re ha bilitati o n cli nicia n 
wit h k n o wle d ge, or s u bject’s p h ys icia n will perf or m me dical scree ni n g or s ufficie nt re vie w of a 
me dical rec or d f or t he s u bjects t hat will partici pat e i n t he pr o p ose d st u dies. T his scree n will be use d 
t o  deter mi ne  if  t he  p ote ntial  s u bjects  ha d  o ne  or m ore  cere bral  str o kes  wit h o ut  ot her  me dical  
c o n diti o ns  (e. g.,  ot her  ne ur ol o gical,  ort h o pe dic,  etc. )  t hat  w o ul d  affect  or  e x plai n  t he  s u bjects’  
wal ki n g or li m b m o ve me nt. Cli nical assess me nts ma y c o nsist of visi o n, pr o pri oce pti o n, gait a nal ysis 
a n d c o g niti ve scree ni n g.  T he 1 0 Meter Wal k Test, Ti me d U p a n d G o Test 2 4, Ber g Bala nce Scale, 
a n d F u ncti o nal Gait Assess me nt tests will be perf or me d  t o assess c ha n ges i n s u bjects’ gait vel ocit y, 
aer o bic  ca pacit y,  a n d  ris k  of  falls,  res pecti v el y,  bef ore,  d uri n g,  a n d  f oll o wi n g  treat me nt.  
A d diti o nall y, se veral ps y c h os ocial o utc o mes will be teste d. 
T o  meas ure  gait,  Veristri de  m oti o n  se ns ors  w ill  be  i nc or p orate d.  T hese  se ns ors,  al o n g  wit h  
a d diti o nal se ns ors will be use d d uri n g all treat me nt sessi o ns creati n g a c o m plete li brar y of data w hile 
usi n g t he de vice d uri n g treat me nt.  T his data will be  a nal y ze d wit h e xisti n g al g orit h ms t o meas ure 
gait para meters as well as assess c ha n g es t hat ma y occ ur as a res ult of i Stri de T M  de vice usa ge. F or 
t he s u bjects i n t his st u d y w h o perf or m treat me nt wit h care gi ver s u per visi o n, t hese se ns ors will all o w 
us t o verif y t hat t he s u bject c o m plete d t he treat me nt  as s pecifie d. A fit bit de vice ma y als o be use d i n 
t his st u d y, i n or der t o trac k c o m plia nce, rec or d tele metr y-relate d data, as well as pr o vi de a n o verall 
c ollecti o n of ste ps per patie nt. 
O ur mai n a nal ysis will be t o c o m pare t he a m o u nt  of lear ni n g (i.e. de viati o ns fr o m s y m metr y p ost-
a da ptati o n) t o n or mal baseli ne s y m metr y. T his will be d o ne usi n g a re peate d meas ures A N O V A t o 
c o m pare baseli ne gait s y m metr y at t he start of t he e x peri me nt t o p ost-a da ptati o n at t he e n d of t he 
e x peri me nt a n d o n t he f oll o w- u p assess me nts. We will q ua ntif y t he a m o u nt of a da ptati o n a n d t he 
c ha n ge i n gait as y m metr y b y c o m pari n g t he ma g nit u de  of ste p le n gt h a n d d o u ble s u p p ort differe nces 
d uri n g  baseli ne,  at  t he  be gi n ni n g  of  treat me nt ,  d uri n g  treat me nt,  a n d  after  treat me nt.  D uri n g  a  
s y m metric gait, ste p le n gt hs o n eac h si de are t he sa me; d uri n g a n as y m metric g ait, ste p le n gt hs are 
differe nt. T hese meas ures are sta n dar d acce pte d meas ures f or meas uri n g gait as y m metries. 
4.
Sa m ple size
Preli mi nar y st u dies wit h t hree healt h y test s u bjects s h o we d statistical data t hat i n dicate d t hat t h e
mi ni m u m n u m b er of s u bjects f or t his st u d y is 1 8.
4 We p o were d t h e t-test bet wee n pre-treat me nt a n d
p ost-treat me nt data. We calc ulate d a n effect size of  0. 6 8 f or ste p le n gt h differe nce, res ulti n g i n a n
esti mate d sa m ple size of 1 8 s u bjects.  T he preli mi nar y test wit h healt h y s u bjects was a p pr o ve d u n der
t he Ei nstei n Healt hcare Net w or k I R B H N 4 3 6 5, a n d ot her preli mi nar y tests wit h healt h y  s u bjects
were c o n d ucte d u n der U S F  I R B Pr o 0 0 0 0 1 8 5 8.
We ha ve n o reas o n t o t hi n k t hat w o me n a n d me n will differ i n t heir a bilities o n a n y of t hese tas ks.
As s uc h, we e x pect t o e nr oll a p pr o xi ma tel y t he sa me n u m ber of me n a n d w o me n.

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9 
5.
I ncl usi o n a n d e xcl usi o n criteria
We will recr uit i n di vi d uals wit h str o ke f or t his  st u d y. If eli gi ble a n d willi n g, i n di vi d uals t hat
partici pate d i n o ur pre vi o us h o me st u d y ma y be all o we d c o nti n ue d partici pati o n. Si nce t he f oc us of
t his pr oject is t o ulti matel y use t his de vice t o hel p str o ke s ur vi v ors, we will recr uit b ot h y o u n g a d ults
a n d ol der a d ults.
I ncl usi o n criteria i ncl u des:
1)
A ge 2 1- 8 0
2)
O ne or m ore cere bral str o k es, b ut all str o kes o n sa me si de
3)
Str o ke occ urre d at least 6 m o nt hs pri or t o e nr oll me nt
4)
Gait as y m metr y, b ut a ble t o wal k i n de pe n de ntl y wit h or wit h o ut a ca ne
5)
N ot c urre ntl y recei vi n g p h ysical t hera p y
6)
N o  e vi de nce  of  se vere  c o g niti ve  i m p air me nt  t hat  w o ul d  i nterfere  wit h  u n dersta n di n g  t he
i nstr ucti o ns
7)
N o e vi de nce of o ne-si de d ne glect, affecti n g a m b ulati o n
8)
At least 2 5 feet of wal ki n g s pace ( d oes n ot nee d t o be a strai g ht li ne)
9)
Wei g ht d oes n ot e xcee d 2 7 5l bs
E xcl usi o n criteria i ncl u des: 
1)
U nc o ntr olle d seiz ures
2)
Metal i m pla nts (ste nts, cli ps, pace ma ker)
3)
Pre g na nc y
4)
Hist or y of a ne ur ol o gical dis or der ot her t ha n str o ke ( Par ki ns o n’s, M S)
5)
C hr o nic O bstr ucti ve P ul m o nar y Disease
6)
U nc o ntr olle d bl o o d press ure
7)
Hea d i nj ur y i n t he past 9 0 da ys
8)
M y ocar dial i nfarcti o n wit hi n t he last 1 8 0 da ys
9)
Ca n n ot rel y o n a r olli n g wal ker f or a m b u lati o n
1 0) Se vere Ata xia
1 1) Pre vi o usl y dia g n ose d vesti b ular ear iss ues
If a patie nt prese nts wit h si g nifica nt ata xia or pre vi o usl y dia g n ose d vesti b ular ear iss ues, t he y are 
e xcl u de d fr o m partici pati o n i n t he p orti o ns of t his trial w here t h e de vice is use d wit h o ut a t hera pist 
prese nt.  P atie nts wit h pre vi o usl y dia g n ose d ata xia or vesti b ular c o n diti o ns ma y still partici pate i n t h e 
part of t he st u d y w here a lice nse d t hera pist is prese n t at all ti mes wit h t he patie nt, after cleara nce b y a 
p h ysicia n a n d t he cli nical t hera pist w h o will i nteract wit h t he patie nt. 
T he e x pecte d res ults of t he researc h 
T his  st u d y  will  e n ha nce  re ha b ilitati o n  met h o ds  use d  f or  l o wer  li m b  re ha bilitati o n,  w hic h  is  
c urre ntl y a d mi nistere d wit h a s p lit- belt trea d mill a n d ot her tra diti o nal met h o ds. T his met h o d ai ms t o 
i m pr o ve u p o n e xisti n g met h o ds a n d t o als o e ve nt uall y e na ble a h o me- base d s ol uti o n. T he st u d y 
res ults  will  be  s u b mitte d  t o  re ha bilitati o n,  ne uroscie nce,  a n d  e n gi neeri n g  p u blicati o ns  f or  
disse mi nati o n t o researc hers a n d cli nicia ns w h o are i ntereste d i n usi n g a n d e x pa n di n g t his met h o d. 
6.
R oles of st u d y staff
T his st u d y is bei n g c o n d ucte d i n se veral ge o gr a p hic areas f or h o me- base d testi n g.  T he h o me-
base d st u d y will be c o n d ucte d b y La ure n Ras hf or d , D P T, Bria n ne Darc y, D P T, Da vi d H uize n ga P h D
a n d K yle Ree d, P h D. S pecific r oles i ncl u de:

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9
 La ure n Ras hf or d a n d Bria n ne Darc y will be r es p o nsi ble f or o verseei n g a n d trai ni n g ne w st u d y 
staff f or t he h o me- base d st u d y 
Dr. Br o w n will pr o vi de me dical o versi g ht f or t he h o me- base d st u d y  
Da vi d H uize n ga a n d K yle Ree d will be  res p o nsi ble f or data a nal ysis  
Sites 
T he  st u d y  will  be  c o n d ucte d  i n  t he  h o me  setti n g  of  eac h  s u bject.  S u bjects  will  be  recr uite d  i n  t h e  
f oll o wi n g ge o gra p hical areas: C harl otte, N C; Gree n ville, S C; Atla nta, G A; a n d H o ust o n, T X.  5 1 7- A W. 
N ort h 3 r d Street, Se neca, S C 2 9 6 7 8 is t he ce ntral place f or st u d y pers o n nel, c o m p uter, a n d e n gi neeri n g.   
7.
P ote ntial ris ks t o t he s u bjects
T he ris ks f or t his st u d y are sli g htl y hi g her t ha n re g ular wal ki n g o ver gr o u n d a n d i ncl u de t he
p ossi bilit y of falli n g. T he ris k ca n be c o m pare d t o  wal ki n g o n hi g h- heele d s h oes. T o mi ni mize t his
ris k,  s u bjects  will  be  scree ne d  f or  a p pr o priate ness  of  trial  partici pati o n  b y  lice nse d  p h ysical
t hera pists.   F or  s u bjects  w h o  ma y  be  per mitte d  t o use  t his  de vice  wit h  care gi ver  s u p er visi o n,
t h or o u g h trai ni n g of all care gi vers will be perf or me d a n d i n- pers o n or vi deo c o nfere nci n g f oll o w- u p
b y  t he  p h ysical  t hera pist  will  occ ur  as  dee me d  necessar y  b y  t he  t hera pist.  S u bjects  deter mi ne d
u na ble t o wal k safel y o n t he de vice b y a n y cli nic ia n usi n g t he de vice u n der t hese c o n diti o ns or a n y
reas o n at a n y ti me will n ot be all o we d t o c o nti n ue or start t he st u d y. As s u c h, t he c o m b i ne d ris ks
ass ociat e d wit h t his st u d y are mi ni mal.
F or t his h o me- base d st u d y, ste ps are ta ke n t o e n s ure safet y. We will use a lice nse d p h ysical
t hera pist t o trai n all care gi vers t o pr o vi de t he ap pr o priate le vel of assista nce t he patie nt nee ds t o
safel y a m b ulate. If t he patie nt is n ot a ble t o a m b ulate safet y o n t he de vice wit h care gi ver s u p er visi o n
or t he care gi ver d oes n ot de m o nstrate t he a bilit y t o safel y s u per vise, t he s u bject will n ot be all o we d
partici pati o n i n t he st u d y. T he s u bject will be a ble  t o call t he p h ysical t hera pist t o disc uss t heir
pr o gress a n d/ or a n y c o ncer ns t hr o u g h o ut t he h o me- ba se d treat me nt, at a n y ti me. T o e ns ure a pr o per
safet y e val uati o n a n d assess me nt of o ne's’ h o me e n vir o n me nt, t he p artici pa nt a n d t heir care gi ver, as
well as t he p h ysical t hera pist, m ust ac k n o wle d ge t h e f oll o wi n g wit hi n t heir h o me: pr o per li g hti n g,
safe hall wa y e ntra nces, a n d re m o val of t hr o w r u gs a n d c or ds. Patie nt a n d care gi ver will recei ve fall
pre ve nti o n e d ucati o n i ncl u di n g e d ucati o n o n t he ris k  of falli n g, certai n safet y iss ues (see a b o ve), a n d
m o bilit y restricti o n. F or e xa m ple, t he de vice is n ot t o  be use d o n stairs. I n a d diti o n t o fall pre ve nti o n,
e d ucati o n will be pr o vi de d o n m o ve me nt patter ns a n d p ositi o n c ha n ges. T he safet y pr o visi o ns will
be disc usse d a n d assesse d pri or t o t he start of treat me nt b y a lice nse d p h ysical t hera pist.
8.
T he p ote ntial be nefits t o s u bjects
T here is p ote ntial f or s u bjects t o i m pr o ve t heir ga it patter ns, gait s pee d, a n d bala nce w hic h is o ur
h y p ot hesis  re gar di n g  t his  met h o d.  It  ma y  n ot  c ha n ge  t heir  gait,  s o  t here  ma y  be  n o  be nefit  t o
s u bjects.
9.
H u ma n s u bject c o nsi derati o ns
a. Descri pti o n of t he i nf or me d c o nse nt pr ocess
U p o n  i nitial  c o ntact,  t he  pri nci pal  i n vesti g at or  will  c o n d uct  a  p h o ne  i nter vie w  a n d  t he
i n vesti gat or will se n d t he c o nse nt f or m t o p ote ntial s u bjects. T his will all o w t he m a n o p p ort u nit y
t o re vie w eli gi bilit y criteria a n d t he c o nse nt f or m wit h o ut feeli n g r us he d a n d will gi ve t he m a
better o p p ort u nit y t o disc uss st u d y partici p ati o n wit h a frie n d or fa mil y me m b er.
T he p ote ntial s u bject will be gi ve n a m ple ti me t o c o nsi der t heir partici pati o n i n t he st u d y a n d
t o as k a n y q uesti o ns he or s he ma y ha ve. If t he i n di vi d ual a grees t o partici pate, t he y will si g n all
i nf or me d c o nse nt d oc u me nts a n d be gi ve n a c o p y t o retai n.
T he writte n c o nse nt f or m will c o ntai n all of t he ele me nts re q uire d b y t he Wester n I nstit uti o nal
Re vie w B oar d ( WI R B) as well as a d here nce t o all fe deral re q uire me nts. T he pri mar y i nf or mati o n

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9 
o n t he c o nse nt f or m will i n cl u de, b ut is n ot li mite d t o, na me of s p o ns or, e x plicit st u d y pr oce d ures, 
ris ks a n d be nefits, s u bject ri g hts, c o nse nt t o use data, a n d st u d y c o ntact i nf or mati o n. Eac h pa ge 
will c o ntai n t he m ost rece nt sta m pe d WI R B a p pr o val pri nte d o n eac h pa ge of t he f or m. It will be 
writte n i n la n g ua ge t hat is u n dersta n da ble t o t he s u bject.  T he ori gi nal si g ne d c o nse nt f or m, if 
d o ne usi n g pa per, will be re tai ne d i n t he st u d y s u bject’s file i n a l oc ke d fili n g ca bi net i n t he office 
of a st u d y staff me m ber, a n d st ore d f or a peri o d of 5- y ears i n acc or da nce wit h WI R B p olic y after 
w hic h ti me p a per rec or ds will be s hre d de d.  T he ori gi nal si g ne d f or m ma y als o be pr o d uce d usi n g 
a certifie d electr o nic si g nat ure pr o gra m, Hell osi g n, w hic h pr o d uces le gal, e xec ute d, d oc u me nts. 
T hese  will  be  retai ne d  i n  t he  s u bject’s  electr o ni c  rec or d,  st ore d  i n  Tr es orit,  a  f ull y  HI P P A  
c o m plia nt cl o u d st ora ge s yste m, as well f or 5- y ears. 
b. Safe g uar ds t o pr otect p ote ntiall y v ul nera ble s u bjects
All s u bjects f or t his st u d y will ha ve at least  n or mal c o g niti ve f u ncti o n as descri be d i n t he
i ncl usi o n re q uire me nts. Care will be ta ke n t o ma ke s ure p ote ntial s u bjects u n dersta n d t he ris ks
a n d t hat t he y ma y n ot recei ve a n y be nefits fr o m t his st u d y.
c. Pri vac y a n d c o nfi de ntialit y
T he si g ne d pa per c o nse nt f or ms will be ke pt c o nfi de ntial a n d st ore d i n a sec ure d l ocati o n. A n y
s oft data c ollecte d will be st ore d i n t he s u bject’s electr o nic rec or d, st ore d i n Tres orit, a f ull y
HI P P A c o m plia nt cl o u d st ora ge s yste m, wit h pass w or d pr otecti o n, d o u ble e ncr y pti o n, a n d li mite d
access  t o  o nl y  necessar y  pers o n nel  w h o  are  u n der c o nfi de ntialit y  a gree me nts  a n d  u n dersta n d
HI P P A  re q uire me nts.  Tele me dici ne  m o dalities  t hat  ma y  be  use d  ( 9zest)  are  f ull y  HI P P A
c o m plia nt. T he data will be a n o n y mize d a n d c o m bi n e d wit h data fr o m ot her e x peri me nts, s o t he
data will n ot be i de ntifia ble t hr o u g h o ut t he st u d y a n d i n all re p orts ge nerate d fr o m t his data.
d. C o m p e nsati o n
S u bjects ma y be pai d f or t his st u d y. Please re fer t o i nf or me d c o nse nt f or m ore detail. 
T he y will be pai d wit hi n 3 0 da ys of t he e n d of t heir partici pati o n i n t he st u d y. 
e. Wit h dra w fr o m t he researc h st u d y
We will disc o nti n ue testi n g if t h e s u bject re p orts or we o bser ve si g ns of disc o mf ort or fati g ue
t hat i nterfere wit h t heir partici pati o n i n t he st u dy. I n a n y of t hese circ u msta nces, t he partici pati o n
will i m me diatel y st o p a n d t he s u bject will be c o m p e nsate d f or his/ her ti me. Please n ote t hat t he
li keli h o o d of partici pa nts e x perie nci n g t hese s y m pt oms d uri n g t he e x peri me nt is n ot greater t ha n
i n  t heir  e ver y da y  li ves  (e. g.  d uri n g  wal ki n g).  Si nce  we  are  perf or mi n g  re peate d- meas ures
statistical tests, it is esse ntial t o o btai n all meas ures fr o m eac h s u bject. T heref ore, if a s u bject is
u na ble t o c o m plete t he e x peri me nt, we will re m o v e  t he data fr o m a nal ysis. Als o, if a s u bject
re q uests t hat his/ her data be wit h dra w n, we will delete it all electr o nic files fr o m o ur rec or ds a n d
destr o y a n y pa per rec or ds.
1 0. Data a n d safet y m o nit ori n g pla n.
T he c ollecte d data will be c o de d s o n o pers o nall y i de ntif yi n g i nf or mati o n will e ver be attac he d t o
t he  data.  T he  l o o k u p  ta ble  will  be  st ore d  se parately  fr o m t he  data.  O nl y  Dr.  H uize n ga,  La ure n
Ras hf or d, a n d Bria n ne Darc y will ha ve access t o t he data a n d t he l o o k u p ta ble. N o o ne b ut t he PI
( La ure n Ras hf or d) a n d st u d y staff will ha ve access t o t he data use d i n t his st u d y. T he data will be
rec or de d t o s prea ds heet a n d/ or te xt files. S h ortl y after t he e x peri me nt, t he data will be a nal y ze d f or
c o m plete ness a n d i nte grit y. It will t he n be c o pie d  t o a re m ote sec ure ser ver a n d bac ke d u p. O nce a
s u bject's e x peri me nt has bee n verifie d, it will o nl y be l o o ke d at as part of all e x peri me nts perf or me d
i n c o nj u ncti o n wit h t his set of e x peri me nts, all of w hic h will be  a n o n y m o us. T he a nal ysis of t he
e ntire data set  (all s u bjects) will occ ur after eac h e x peri ment.

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9
1 1. Researc h f u n di n g i nf or mati o n
T his st u d y will be f u n de d b y M oter u m Tec h n ol o gi es I nc., w hic h is a c o m pa n y t hat e val uates
tec h n ol o gies relate d t o re ha bilitati o n wit h t he i ntenti o n of c o m mercializi n g via ble tec h n ol o gies a n d
bri n gi n g t he m t o mar ket.
M oter u m Tec h n ol o gies I nc. has lice nse d t w o pate nts fr o m U S F, w hic h ha ve Dr. Ree d a n d Mr.
Ha n dzic liste d as t he i n ve nt ors:
U S F  1 3 B 1 5 4 P R _ Ha n dzic  file d  i n  Fe b.  2 0 1 4:  " S Y S T E M S  A N D  M E T H O D S  F O R  
D E SI G NI N G KI N E TI C S H A P E S". T his is a pr o vi si o nal pate nt f or a met h o d t o ge nerate a 
s piral-s ha pe d w heel t hat ge nerates a k n o w n h oriz o ntal f orce or m o me nt w h e n a vertical 
f orce is a p plie d o n it. It ca n be use d t o s pecif y t he s ha pe of w heels t hat re direct f orces a n d 
ca n  als o  be  use d  t o  defi ne  t he  r oll- o ver  s h a pe  of  a  f o ot  wit h  t he  gr o u n d  t o  alter  t he  
i nteracti o n a n d res ulti n g gait. 
U S F 1 1 B 1 7 0 P R file d i n Fe b. 2 0 1 2: " G AI T A L T E R I N G S H O E". T his pate nt is f or a s h oe 
t hat ge nerates a bac k war d or f or war d m oti o n w he n t he user ste ps d o w n o n t he s h oe. T he 
s h oe ca n be use d f or re ha bilitati o n of i n di vid uals wit h str o ke, s pecificall y f or c orrecti n g 
t heir as y m metric gait, a n d als o f or healt h y i ndi vi d uals t o i ncrease t heir f or war d pr o gressi o n 
wit h eac h ste p.  
I n a d diti o n t o t he pate nts, Dr. Ree d has bee n as ke d t o ser ve o n t he A d vi s or y B oar d f or M oter u m 
Tec h n ol o gies I nc, w hic h i ncl u des a y earl y h o n orari u m a n d st oc k o pti o ns i n t he c o m pa n y. A c o nflict 
of i nterest ma na ge me nt pla n has bee n p ut i n place a n d a p pr o ve d b y U S F a n d t he WI R B.  
Researc h Refere nces 
1. 
Reis ma n D S, Bastia n AJ. S P LI T- B E L T T R E A D MI L L A D A P T A T I O N a n d G AI T S Y M M E T R Y
P O S T- S T R O K E. 2 0 0 5; 2 9( 4): 1 9 6.
2. 
Reis ma n D S, Wit y k R, Sil ver K, Bastia n AJ. L oc o m ot or a da ptati o n o n a s plit- belt trea d mill ca n
i m pr o ve wal ki n g s y m metr y p ost-str o ke. Br ai n. 2 0 0 7; 1 3 0( Pt 7): 1 8 6 1- 1 8 7 2.
3. 
Reis ma n D S, Wit y k R, Sil ver K, Bastia n AJ. S plit- belt trea d mill a da ptati o n tra nsfers t o
o ver gr o u n d wal ki n g i n pers o ns p oststr o ke. Ne ur ore h a bil Ne ur al Re p air. 2 0 0 9; 2 3( 7): 7 3 5- 7 4 4.
4.  
Ha n dzic I, Bar n o E M, Vas u de va n E V, Ree d K B. Desi g n a n d Pil ot St u d y of a Gait E n ha nci n g
M o bile S h oe. P al a dy n. 2 0 1 1; 2( 4).
5.  
Ha n dzic I, Ree d K B. C o m paris o n of t he passi ve d y na mics of wal ki n g o n gr o u n d, tie d- belt a n d
s plit- belt trea d mills, a n d via t he Gait E n ha nci n g M o bile S h oe ( G E M S). I E E E I nt C o nf Re h a bil
R o b ot. 2 0 1 3; 2 0 1 3: 6 6 5 0 5 0 9.
6.  
Ha n dzic I, Vas u de va n E, Ree d K B. De v el o pi n g a Gait E n ha nci n g M o bile S h oe t o Alter O ver-
Gr o u n d Wal ki n g C o or di nati o n. I E E E I nt C o nf R o b ot A ut o m. 2 0 1 2; 2 0 1 2: 4 1 2 4- 4 1 2 9.
7.  
Ha n dzic I, Vas u de va n E V, Ree d K B. M oti o n c o ntr olle d gait e n ha nc i n g m o bile s h oe f or
re ha bilitati o n. I E E E I nt C o nf Re h a bil R o b ot. 2 0 1 1; 2 0 1 1: 5 9 7 5 4 1 7.
8.  
Writi n g Gr o u p M, Ll o y d-J o nes D, A da ms RJ, et al. Heart disease a n d str o ke statistics-- 2 0 1 0
u p date: a re p ort fr o m t he A mer ica n Heart Ass ociati o n. Circ ul ati o n. 2 0 1 0; 1 2 1( 7):e 4 6-e 2 1 5.
9.  
Kell y- Ha y es M, Beiser A, Kase C S, Scara m ucci A, D' A g osti n o R B, W olf P A. T he i nfl ue nce of
ge n der a n d a ge o n disa bilit y f oll o wi n g isc he mic str o ke: t he Fra mi n g ha m st u d y. J Str oke
Cere br ov asc Dis. 2 0 0 3; 1 2( 3): 1 1 9- 1 2 6.
1 0. 
Bra n dstater M E, de Br ui n H, G o wla n d C, Cl ar k B M. He mi ple gic gait: a nal ysis of te m p oral
varia bles. Arc h P hys Me d Re h a bil. 1 9 8 3; 6 4( 1 2): 5 8 3- 5 8 7.
1 1.  
Wall J C, T ur n b ull GI. Gait as y m metries i n resi d ual he mi ple gia. Arc h P hys Me d Re h a bil.
1 9 8 6; 6 7( 8): 5 5 0- 5 5 3.
1 2. 
Titia n o va E B, Tar k ka I M. As y m metr y i n wal ki n g perf or ma nce a n d p ost ural s wa y i n patie nts wit h
c hr o nic u nilateral cere bral i nfarcti o n. J Re h a bil Res Dev. 1 9 9 5; 3 2( 3): 2 3 6- 2 4 4.

Pr ot oc ol versi o n H o me St u d y, u p date d o n A pril 8, 2 0 1 9 
1 3. 
Balas u bra ma nia n C K, B o w de n M G, Ne pt u ne R R,  Ka utz S A. Relati o ns hi p bet wee n ste p le n gt h
as y m metr y a n d wal ki n g perf or ma nce i n s u bjects wit h c hr o nic he mi paresis. Arc h P hys Me d
Re h a bil. 2 0 0 7; 8 8( 1): 4 3- 4 9.
1 4.  
Ol ne y SJ, Griffi n M P, Mc Bri de I D. Te m p oral, ki ne matic, a n d ki netic va ria bles relate d t o gait
s pee d i n s u bjects wit h hemi ple gia: a re gressi o n a p pr oac h. P hys T her. 1 9 9 4; 7 4( 9): 8 7 2- 8 8 5.
1 5. 
B o w de n M G, Balas u bra ma nia n C K, Ne pt u ne R R, Ka utz S A. A n teri or- p osteri or gr o u n d reacti o n
f orces as a meas ure of paretic le g c o ntri b uti o n i n he mi paretic wal ki n g. Str oke. 2 0 0 6; 3 7( 3): 8 7 2-
8 7 6.
1 6.
Br o u wer B, Par vata ne ni K, Ol ne y SJ. A c o m paris o n of gait bi o mec ha nics a n d meta b olic
re q uire me nts of o ver gr o u n d a n d trea d mill wal ki n g i n pe o ple wit h str o ke. Cli n Bi o mec h ( Brist ol,
Av o n). 2 0 0 9; 2 4( 9): 7 2 9- 7 3 4.
1 7.  
Ka h n J H, H or n b y T G. Ra pi d a n d l o n g-ter m a d a ptati o ns i n gait s y m metr y f oll o wi n g u nilateral
ste p trai ni n g i n pe o ple wit h he mi paresis. P hys T her. 2 0 0 9; 8 9( 5): 4 7 4- 4 8 3.
1 8.
I ve y F M, Mac k o R F, R y a n A S, Hafer- M ac k o C E. Car di o vasc ular healt h a n d fit ness afte r str o ke.
T o p Str oke R e h a bil. 2 0 0 5; 1 2( 1): 1- 1 6.
1 9.
Kear ne y R E. C o nte xt de pe n de nce of i ntri nsic a n d refle x c o ntri b uti o ns t o a n kle stiff ness. Pa per
prese nte d at: First I nter nati o nal I E E E E M B S C o nfere nce o n Ne ural E n gi neeri n g, 2 0 0 3.
C o nfere nce Pr ocee di n gs.;  2 0- 2 2 Marc h 2 0 0 3, 2 0 0 3.
2 0. 
Br o nstei n A M, B u n da y K L, Re y n ol ds R. W h at t he " br o ke n escalat or" p he n o me n o n teac hes us
a b o ut bala nce. A n n N Y Ac a d Sci. 2 0 0 9; 1 1 6 4: 8 2- 8 8.
2 1.
Re y n ol ds R F, Br o nstei n A M. T he br o ke n escalat or p he n o me n o n. Aftereffect of wal ki n g o nt o a
m o vi n g platf or m. Ex p Br ai n Res. 2 0 0 3; 1 5 1( 3): 3 0 1- 3 0 8.
2 2. 
T orres- O vie d o G, Bastia n AJ. Seei n g is belie vi n g: effects of vis ual c o nte xt ual c ues o n lear ni n g
a n d tra nsfer of l oc o m ot or a da ptati o n. J Ne ur osci. 2 0 1 0; 3 0( 5 0): 1 7 0 1 5- 1 7 0 2 2.
2 3.  
Gra n ger C V, De utsc h A, Li n n R T. Rasc h a nal ys is of t he F u ncti o nal I n de pe n de nce Meas ure ( FI M)
Master y  Test. Arc h P hys Me d Re h a bil. 1 9 9 8; 7 9( 1): 5 2- 5 7.
2 4.  
A n derss o n A G, Ka m we n d o K, Sei ger A, A p pelr os P. H o w t o i de ntif y p ote ntial fa llers i n a str o ke
u nit: vali dit y i n de xes of 4 test met h o ds. J Re h a bil Me d. 2 0 0 6; 3 8( 3): 1 8 6- 1 9 1.
8