Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm
Phase: NA
Conditions: Stroke
Sponsor: University of Minnesota

 
 
Efficacy of a Forearm Rotation Orthosis for Persons with a Hemiparetic Arm 
 
 
 
Study Protocol 
 
 
Date: 2/23/2017 
Chih-Huang Yu, MS, OT (Primary Investigator) 
Virgil Mathiowetz, PhD, OTR/L (Academic Advisor)  
Rehabilitation Science Program, University of Minnesota 
 
 

Table of Content 
Background and Rationale for study ………………………………………………………………. 1 
Methodology ………………………………………………………………………………………………… 3 
Study design …………………………………………………………………………………….… 3 
Objectives ………………………………………………………………………………………….. 4 
Study endpoints: primary and secondary endpoints …………….……………… 5 
Treatment Allocation …………………………………………………….…………………… 5 
Sample Size considerations …………………………………………….…………………... 7 
Participant selection: inclusion and exclusion criteria …………….…………… 7 
Study Plan …………………………………………………………………………….…………… 9 
Intervention ……………………………………………………….…………………… 9 
Potential risk of the orthosis ……………………………………………………. 14 
Data collection Plan and Schedule …………………….……………………… 15 
Evaluation ………………………………………………………………………………….………………… 15 
Data analysis  ………...………………………………………………………….…………….….. 15 
Data monitor ………………………………………………………………….….…….…………. 16 
Treatment Fidelity ……………………………………………………………………………………….... 17 
 
Project personnel training …………………………………………………………………… 17 
References ……………………………………………………………………………....……………………. 19 
Appendix A  …………………………………………………………………………………………………… 23 
 

Background and Rationale for Study 
Functional use of the upper limb during tasks requires coordination of joints of the 
upper extremity (van Andel, Wolterbeek, Doorenbosch, Veeger, & Harlaar, 2008).  Persons 
with central nervous system (CNS) dysfunction often have difficulty incorporating their 
affected limb effectively and efficiently into functional activities due to muscle weakness 
and/or spasticity (Gillen, 2011).  Poor functional use of the affected limb and/or motor 
recovery may lead to development of learned nonuse of the affected limb (Taub, Uswatte, & 
Pidikiti, 1999), compensatory movement patterns (Mackey, Walt, & Stott, 2006) as well as 
muscle or joint contracture (Milazzo & Gillen, 2011).  This may further interfere with their 
occupational performance and restrict life roles.   
Traditional rehabilitation interventions emphasize motor training on the reduction of 
spasticity (Gillen, 2011).  However, active movement and muscle strength of forearm 
supination are found strongly associated with motor function recovery, rather than 
spasticity (Braendvik, Elvrum, Vereijken, & Roeleveld, 2010; O’Dwyer, Ada, & Neilson, 
1996).  In contrast, task-oriented functional training trials, such as the occupational 
therapy (OT) task-oriented approach (Almhdawi, 2011; Flinn, 1995) and the Constraint-
Induced Movement Therapy (Page, Levine, & Leonard, 2005; Page, Levine, Leonard, 
Szaflarski, & Kissela, 2008; Taub, Uswatte, & Elbert, 2002; Taub et al., 2006; Wolf et al., 
2008), have demonstrated promising evidence that persons with CNS dysfunction benefit 
from the training in improvement of increase functional use and motor function of the 
affected limb.  However, the role of forearm movements is not addressed in rehabilitation 
interventions literature.   

Orthosis for stroke 
Protocol Number: 1309M42881 
 
2 
Occupational therapists often employ orthotic interventions for persons with CNS 
dysfunction (Milazzo & Gillen, 2011; Watanabe, 2004).  Most orthotic designs are static and 
aimed at the wrist and/or hand with purposes of spasticity reduction, correction or 
prevention of deformity (Milazzo & Gillen, 2011).  However, the effects remain 
controversial (Lannin & Herbert, 2003).  Given that static orthoses may interfere with 
functional performance and may further develop muscle or joint contracture, 
compensatory movements or learned nonuse of the affected limb (Mell, Childress, & 
Hughes, 2005; Milazzo & Gillen, 2011), a dynamic or mobilization orthosis can be 
considered to assist or enhance functional use of the affected limb during functional tasks 
(Dunning et al., 2008; Farrell, Hoffman, Snyder, Guiliani, & Bohannon, 2007; Hoffman & 
Blakey, 2011; Lannin & Ada, 2011; Pitts & O’Brien, 2008).  However, research evidence 
regarding the effects of an orthosis that assists forearm movements for this population 
found in the literature is limited.   
The proposed research project will use a randomized clinical trial to investigate the 
efficacy of a forearm rotation orthosis combined with the OT task-oriented approach for 
persons with a hemeparetic arm on functional performance, motor function, and range of 
motion. We expect that the results would significantly improve participants’ functional 
performance and motor function as well as prevent or reduce secondary complications due 
to CNS dysfunction. The results may also benefit the rehabilitation professions in 
developing treatment protocols for this population.   
 
 
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
3 
Methodology 
Study design  
 
This study will employ a randomized, single-blinded, two-group, repeated measure 
design (Table 1).  
Table 1. Experimental design of the internal pilot study   
Group/Week 
Week 1 
Week 2-7 
Week 8 
Week 9-14 
Week 15 
M 
R 
A 
O1 
Orthosis 
O2 
Orthosis+OTTO 
O3 
M 
R 
B 
O1 
No treatment 
O2 
OTTO 
O3 
Note. M = matching with severity of motor function of the upper extremity; R = random 
assignment; O1,2,3 = time points for outcomes measures; Orthosis = six weeks of forearm 
rotation-assist orthotic intervention; OTTO = six weeks of OT task-oriented approach 
intervention. 
 
Objectives  
The primary purpose of this study is to investigate the efficacy of a forearm rotation 
orthosis combined with the OT task-oriented approach for persons with a hemiparetic arm. 
Hypotheses of this study are that 1) participants who wear the forearm rotation orthosis 
will demonstrate significantly greater improvement in functional performance and active 
range of motion of forearm rotators compared to those who do not; 2) all participants who 
receive the OT task-oriented approach intervention will demonstrate significant 
improvement in functional performance; and 3) all participants who receive the OT task-
oriented approach intervention will demonstrate significant improvement in motor 
function of the upper extremity.  
Study endpoints 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
4 
The primary endpoint is the functional improvement. “Functional improvement” 
represents improvement in the performance of everyday activities. The secondary 
endpoints are active range of motion and muscle strength, including grip and pinch, of the 
involved upper extremity as well as orthosis compliance.  
Outcome measures for the primary endpoint include the Canadian Occupational 
Performance Measure (COPM) for self-perceived functional performance and satisfaction 
with performance, the Wolf Motor Function Test (WMFT) for quantitatively measuring the 
motor function of the upper extremity, and the Motor Activity Log (MAL) for measuring 
participants’ actual use of the involved arm in the real world.  
Outcome measures used for the secondary endpoints include goniometric 
measurements for active and passive range of motion (ROM), hand-held dynamometry and 
manual muscle testing for muscle strength of the upper extremity, Jamar Dynamometer for 
grip strength, pinch gauge for pinch strength, as well as information collected by the Nike+ 
FuelBand regarding numbers of hours they wear the orthosis everyday throughout the 
study period for adherence with the orthosis.  
Treatment allocation 
 
Participants who are eligible and willing to participate in this study will first be 
matched with the severity of the motor function of the involved upper extremity measured 
by the upper extremity subscale of the Short Form Fugl-Meyer Motor Function Assessment. 
Participants will be classified as mild, moderate, and severe groups. Participants in each 
group will then be randomized in a 1:1 allocation ratio to either the Group A or B (Figure 
1). The primary investigator, Chih-Huang Yu, will randomly assign eligible participants at 
the screening session using sealed envelopes with an equal number of both intervention 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
5 
conditions to balance group size (10 for each matched group with 5 Group As and 5 Group 
Bs). 
 
 
Figure 1. Study schematic for treatment allocation. 
 
 
 
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
6 
Sample size estimation 
We plan to enroll 30 participants in the study. Based on anticipated number of 
screen failures and/or withdrawals, the maximum number of participants whom we will 
consent in order to achieve the scientific objectives of this study is 40. Note that the 
number of participants described above is a rough estimate of the sample size needed, 
since there is no evidence to address the primary question of interest. This proposed 
project involves pilot/preliminary investigation, which will be used to calculate the effect 
sizes that need to be used for the future study. 
Participant selection  
The target population for this study is stroke patients who have a hemiparetic arm.  
Subjects will be recruited from a) local hospitals and institutions in the Twin Cities metro 
area, including advertising at Fairview hospitals and the stroke center at the North 
Memorial Hospital and b) the Onsite clinic at the University of Puget Sound at which the PI 
was a graduate from the occupational therapy program.  
Inclusive criteria in this study include: 
Participants  
1) Have a diagnosis of stroke for at least three months,  
2) Be 18 years of age or older,  
3) Have sufficient cognitive function to follow three-step verbal instruction  
     and provide independent consent,  
4) Have appropriate trunk and lower extremity function that does not 
     interfere with performance of the upper extremity,  
5) Have at least minimum voluntary movement in the upper extremity (10  

Orthosis for stroke 
Protocol Number: 1309M42881 
 
7 
     degrees of shoulder flex/abduction, 10 degrees of elbow  
     flexion/extension), and  
6) Not receive any rehabilitative interventions concurrent with the study.  
Exclusive criteria include:  
1) Severe joint deformities or contractures of the affected upper extremity 
that limit range of motion required for functional tasks,  
2) Capability of voluntarily extending the wrist and fingers through the full  
range,  
3) Have serious uncontrolled medical problems, such as seizures and visual  
      impairment.  
Interested persons, who begin pharmacological treatments for management of 
spasticity, such as Botox and Baclofen, before the study and sustain these throughout the 
study period, will be permitted to participate. Interested persons who use pharmacological 
treatment for spasticity reduction, such as Botox or Baclofen, and then stop treatment, are 
excluded until they are at least 4 months past their last use of the medications. Persons 
who enroll in the study while using Botox or Baclofen will be removed from the study if 
they stop that treatment during the study period.  Timeline for consenting is illustrated in 
Figure 2.  

Orthosis for stroke 
Protocol Number: 1309M42881 
 
8 
 
Figure 2. Timeline for consenting.  
Study plan 
Intervention. Participants in the Group A will experience the orthotic intervention 
followed by the orthosis plus OT task-oriented approach intervention. Participants in the 
Group B will first undergo a period of no treatment followed by the OT task-oriented 
approach only (Figure 3).  
 
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
9 
 
Figure 3. Flowchart for the proposed protocol.  
Use of the Nike + FuelBand as monitor and placebo. The Nike+ FuelBand will 
serve as a monitor for all participants throughout their study period. The FuelBand is a 
commercially available wristband designed to measure activities throughout a day. The 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
10 
wristband is available in three sizes. Researcher will adjust the length for each participant, 
by removing 8mm link or adding up to 16mm to each wristband.  
All participants will wear the Nike+ FuelBand at the wrist level throughout the study 
period and will be informed that the wristband is used to monitor their use of the arms 
during a day. Participants experiencing the orthotic intervention (Group A) will wear the 
forearm rotation orthosis on top of this wristband. All participants will receive weekly 
phone calls from the investigator reminding them to recharge the wristband because the 
wristband needs to be recharged by connecting to a computer or any device with USB port 
every 4-7 days.  
Conditions involving OT task-oriented approach intervention consists of 18 hours of 
intervention time (three one-hour or two 1.5-hour session per week) of functional and 
motor training. Each session will concentrate on how to engage the affected arm actively, 
effectively, and efficiently in functional tasks that are meaningful to the participant. 
Suggested evaluation and intervention procedures for the OT task-oriented approach are 
illustrated in Figure 4 and 5.  
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
11 
 
Figure 4. Flowchart for suggested evaluation procedure for OT task-oriented approach. 
Copied from Almhdawi (2011) with permission.   

Orthosis for stroke 
Protocol Number: 1309M42881 
 
12 
 
Figure 5. Flowchart for suggest treatment for OT task-oriented approach. Copied from 
Almhdawi (2011) with permission. 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
13 
The forearm rotation orthosis (Figure 6) is consisted of a commercial fabric wrist 
orthosis and a Latex-free neoprene strap. This orthosis is designed to assist forearm 
rotation without limiting functional elbow flexion and extension. During the phase of 
orthotic intervention only, participants will be asked to wear the orthosis on top of the 
Nike+ FuelBand  of their affected arm during functional tasks within their context. The 
primary investigator will make three bi-weekly phone calls during the experiment phase 
for enhancing adherence with orthosis and reminding them to recharge the wristband. 
Participants will also be asked to wear the orthosis and the wristband for the following 
experiment phase, including research visits, and will be encouraged to continue wear it 
within their context. However, they will be asked not to wear the orthosis at evaluation 
sessions to maintain the integrity of the design.  
 
Figure 6. The forearm rotation orthosis.  
 
Potential risk of the orthosis. No risks regarding using the neoprene for a dynamic 
orthosis were identified in the literature. Using the forearm rotation orthosis for the 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
14 
proposed study, we hypothesize that possible risks may include but not be limited: 1) skin 
irritation over contact areas, 2) increased muscle soreness when increased use of the arm, 
and/or 3) movement restriction of the involved upper extremity during functional tasks. 
Participants will need to remove the orthosis immediately and report to the primary 
investigator if any of above symptoms develops. Information regarding possible risks of 
use of the orthosis is included in the consent form as well as the written instructions 
(Appendix A). The primary investigator will provide verbal education and written 
instructions regarding orthosis use and care to the participants after orthosis fabrication.   
Data collection plan and schedule. The timing of screening, randomization, and 
follow-up visits are illustrated in Figure 2. The primary investigator will screen potential 
participants’ eligibility using the Mini-Mental Status Examination (MMSE), the Short Form 
Fugl-Meyer (S-FM), and ROM. There will be three time points for data collection (pretest, 
posttest 1, and posttest 2). Trained occupational therapy students recruited from the 
University of Minnesota and University of Puget Sound will serve as the blinded evaluators 
to implement all assessments except the COPM for each research site.  The primary 
investigator will administer the COPM to obtain information that will be used to guide 
future interventions.  
Evaluation 
Data analysis 
The R software will be used for data analyses. Descriptive statistics will be used to 
analyze the demographic data, baseline information, and adherence with orthosis wearing. 
The linear mixed-effects model regression will be used as the omnibus test for examination 
of effect of intervention involving orthosis across time in comparison of that without. The 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
15 
systematic or fixed effects of this study are group assignment and time. Main effect of the 
two factors and the interaction effect between the two will be explored. Study participants 
will be considered and added into the model as the random effects.  
General linear regression model will be used to determine effects of experimental 
conditions between the two groups. Data obtained from the pretest will first be used to 
examine if there are differences in outcome measures between the two groups. It will also 
serve as a covariate while examining difference between the two groups at the posttest 1. 
Data from the posttest 1 will serve as a covariate while examining difference between the 
two groups at the posttest 2. The paired t test will be used to examine difference within 
each group for each intervention period across time.  
Interim monitoring of the data will occur after 16 participants complete the study. If 
the study results indicate a significant decline in functional performance for either group 
across the 12-week study, the study will be terminated.  If there are serious adverse effects, 
the study would be terminated.  
Data monitor 
The academic advisor, Virgil Mathiowetz, is the founder of the OT task-oriented 
approach. He will monitor study procedures to ensure fidelity to the OT task-oriented 
approach. The academic advisor will work closely with the study investigators for safety 
monitoring throughout the study period.  He will supervise the primary investigator, Chih-
Huang Yu, with the development and implementation of the treatment plan for study 
participants.  The principle investigator will train the blinded evaluators of both sites on all 
assessment tools until total agreement is achieved.  The blinded assessor will execute all 
evaluations and the primary investigator will complete the data entry accumulatively. The 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
16 
academic advisor will also check and monitor the accuracy of data collection, data entry, 
and data analyses. 
All information gathered for the study will be converted into digital files and 
uploaded within 24 hours to the “Box” secure storage operated by the University of 
Minnesota. The Box is an online storage space that allows storing Protected Health 
Information (PHI). Only the principle investigator has the access to “Box” as it requires 
duo-factor authentication to log in. Information on the “Box” is at http://box.umn.edu 
Subjects’ name and contact information will be kept in a separate file from the data 
gathered from the study using an ID code.  All printed documents will be converted into 
digital files and uploaded to Box. Printed documents will then be immediately shredded.  
Identifying materials such as the consent forms gathered from the University of 
Minnesota site will be kept in a locked file cabinet in the rehabilitation science graduate 
student office, which requires security code for access. Personnel from the department 
have access to the office. However, only the primary investigator has access to locked file 
cabinet that keeps the study information.  Identifying materials such as the consent forms 
obtained from the onsite clinic at the University of Puget Sound will be kept in a locked file 
in the Occupational Therapy Department at the University of Puget Sound, WEY 106.  Data 
collected from this study will be maintained for three years after completion of the study, 
then shredded. 
Treatment Fidelity 
Project personnel training 
 
Interventionists. The principle investigator, Chih-Huang Yu, serves as the primary 
interventionist. He will provide the Occupational Therapy Task-Oriented Approach (OTTO) 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
17 
based interventions for most participants throughout the study period. He will work 
closely and regularly with Dr. Virgil Mathiowetz, the theorist behind the OTTO approach 
and the academic advisor, to ensure fidelity to the OTTO, monitor safety during the study 
period, and supervise the primary interventionist for the development and implementation 
of the OTTO based treatment plan.  
 
The primary interventionist will develop treatment plans for all participants using 
the Canadian Occupational Performance Measure. The secondary investigator, Matthew 
White, functions as a backup therapist when the primary interventionist is not available. He 
is a certified occupational therapist working at the Courage Kenny Research Institute and 
has participated in the previous clinical trial of OTTO. 
 
Prior to data collection, the primary and the secondary investigators will discuss the 
concepts and procedures of OTTO based interventions. The primary interventionist will 
observe the backup therapist implementing the first one or two sessions for each study 
participant and discuss the content of treatment afterwards. The two will communicate via 
face-to-face and email discussions. If the secondary investigator becomes unavailable 
during the period of study, a third therapist will be sought and the same training procedure 
will be implemented.  
 
Blinded evaluator. The blinded evaluators are occupational therapy students at 
University of Minnesota and University of Puget Sound. Each evaluator will conduct all 
evaluations for the same study participants, except the Canadian Occupational Performance 
Measure. The primary investigator will work with blinded evaluators on the 
implementation of the Wolf Motor Function Test, Motor Activity Log, ROM, and strength 
assessments.  Inter-rater reliability:  Prior to enrollment of the first participant, 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
18 
measurements between the primary investigator and the blinded evaluators will be within 
the standard error of measurement for each outcome measure prior to the enrollment of 
the first participant. 
 
 
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
19 
References 
Almhdawi, K. (2011). Effect of occupational therapy task-oriented approach in upper  
 
extremity post-stroke rehabilitation. (Unpublished PhD). University of Minnesota,  
 
MN, USA. 
Braendvik, S. M., Elvrum, A. G., Vereijken, B., & Roeleveld, K. (2010). Relationship between  
neuromuscular body functions and upper extremity activity in children with cerebral palsy.  
Developmental Medicine & Child Neurology, 52, e29-e34. doi:10.1111/j.1469- 
8749.2009.03490.x 
Dunning, K., Berberich, A., Albers, B., Mortellite, K., Levine, P. G., Hill Hermann, V. A., & Page, S. 
J. (2008). A four-week, task-specific neuroprosthesis program for a person with no active 
wrist or finger movement because of chronic stroke. Physical Therapy, 88, 397-405. 
doi:10.2522/ptj.20070087 
Farrell, J. F., Hoffman, H. B., Snyder, J. L., Giuliani, C. A., & Bohannon, R. W. (2007). Orthotic 
aided training of the paretic upper limb in chronic stroke: Results of a phase 1 trial. 
NeuroRehabilitation, 22, 99-103. 
Flinn, N. (1995). A task-oriented approach to the treatment of a client with hemiplegia. 
American Journal of Occupational Therapy, 49(6), 560-569. 
Gillen, G. (2011). Upper extremity function and management. In G. Gillen (Ed.), Stroke 
rehabilitation: A function-based approach (3rd ed., pp. 218-279). St. Louis: Mosby. 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
20 
Hoffman, H. B. & Blakey, G. L. (2011). New design of dynamic orthoses for neurological 
conditions. NeuroRehabilitation, 28, 55-61. doi:10.3233/NRE-2011-0632 
Lannin, N. A., Horsley, S. A., Herbert, R., McCluskey, A., & Cusick, A. (2003). Splinting the hand in 
the functional position after brain impairment: A rondomized, controlled trial. Archives 
Physical Medicine and Rehabilitation, 84, 297-302.  
Lannin, N. A. & Ada, L. (2011). Neurorehabilitation splinting: Theory and principles of clinical use. 
NeuroRehabilitation, 28, 21-28. doi:10.3233/NRE-2011-0628 
Mackey, A. H., Walt, S. E., & Stott, N. S. (2006). Deficits in upper-limb task performance in 
children with hemiplegic cerebral palsy as defined by 3-Dimensional kinematics. Archives 
Physical Medicine and Rehabilitation, 87, 207-215. doi:10.1016/j.apmr2005.10.023 
Mell, A. G., Childress, B. L., & Hughes, R. E. (2005). The effect of wearing a wrist splint on 
shoulder kinematics during object manipulation. Archives Physical Medicine and 
Rehabilitation, 86, 1661-1664. doi:10.1016/j.apmr.2005.02.008 
Milazzo, S., & Gillen, G. (2011). Splinting applications. In G. Gillen (Ed.), Stroke rehabilitation: A 
function-based approach (3rd ed., pp. 326-349). St. Louis: Mosby. 
O'Dwyer, N. J., Ada, L., & Neilson, P. D. (1996). Spasticity and muscle contracture following 
stroke. Brain, 119, 1737-1749.  

Orthosis for stroke 
Protocol Number: 1309M42881 
 
21 
Page, S. J., Levine, P., & Leonard, A. C. (2005). Modified constraint-induced therapy in acute 
stroke: A randomized controlled pilot study. Neurorehabilitation and Neural Repair, 19(1), 
27-32. doi:10.1177/1545968304272701 
Page, S. J., Levine, P., Leonard, A., Szaflarski, J. P., & Kissela, B. M. (2008). Modified constraint-
induced therapy in chronic stroke: Results of a single-blinded randomized controlled trial. 
Physical Therapy, 88, 333-340. doi:10.2522/ptj.20060029 
Pitts, D. G. & O’Brien, S. P. (2008). Splinting the hand to enhance motor control and brain 
plasticity. Top Stroke Rehabilitation, 15(5), 456-467. doi:10.1310/tsr1505-456 
Taub, E., Uswatte, G., & Elbert, T. (2002). New treatment in neurorehabilitation founded on 
basic research. Nature Reviews, 3, 228-236. doi:10.1038/nrn754 
Taub, E., Uswatte, G., King, D. K., Morris, D., Crago, J. E., & Chatterjee, A. (2006). A placebo-
controlled trial of constraint-induced movement therapy of upper extremity after stroke. 
Stroke, 37, 1045-1049. doi:10.1161/01.STR.0000206463.66461.97 
Taub, E., Uswatte, G., & Pidikiti, R. (1999). Constraint-induced movement therapy: A new family of 
techniques with broad application to physical rehabilitation—A clinical review. Journal of 
Rehabilitation Research and Development, 36(3), 237-251.  
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
22 
van Andel, C. J., Wolterbeek, N., Doorenbosch, C. A. M., Veeger, D., & Harlaar, J. (2008). Complete 
3D kinematics of upper extremity functional tasks. Gait & Posture,27, 120-127. 
doi:10.1016/j.gaitpost.2007.03.002 
Watanabe, T. (2004). The role of therapy in spasticity management. American Journal of 
Physical Medicine and Rehabilitation, 83, S45-S49. 
doi:10.1097/01.PHM.0000140130.58285.DA 
Wolf, S. L., Winstein, C. J., Miller, J. P., Thompson, P. A., Taub, E., Uswatte, G., Morris, B., …  
 
Clark, P. C. (2008). Retention of upper limb function in stroke survivors who have  
 
received constraint-induced movement therapy: the EXCITE randomized trial.  
 
Lancet Neurology, 7, 33-40.  
 
 

Orthosis for stroke 
Protocol Number: 1309M42881 
 
23 
Appendix A 
 
Instructions*for*orthosis/splint*use*and*care*
!
The*forearm*rotation*splint*that*you*will*wear*on*your*weaker*arm*combines*a*wrist*splint*and*a*
neoprene*strap*
o The!wrist!splint!has!a!single!pull!lace!closures.!It!allows!you!to!easily!put!it!on!and!adjust!
with!one!hand.!!
o The!neoprene!strap!is!Latex9free.!This!elastic!strap!will!assist!the!forearm!rotation!
movement!of!your!weaker!arm.!!
*
How*to*put*on*the*splint:**
• 1st!!Put!on!the!wrist!splint!and!fasten!the!Velcro!strap!of!the!splint.!(Figure!1!and!2)!
• 2nd!Attach!one!end!of!the!strap!to!the!wrist!splint!at!the!wrist*level!of!the!pinky&side.!(Figure!3)!
• 3rd!Straighten!your!elbow!with!your!palm!facing!the!ceiling.!(Figure!4)!
• 4th!Wrap!the!strap!at!an!angle!around!the!forearm,!continuing!up!to!the!elbow.!(Figure!5)!Do*not*
wrap*the*strap*too*tight.!You!don’t!want!to!restrict!circulation.!!
• 5th!Attach!the!end!of!the!strap!to!itself.!!(Figure!6)!
****************
****************
*
Figure!1.!!!!!!
!
!
!
!!!!!Figure!2.!! !
!
!
!
Figure!3.!!
*
****************
********************
*
Figure!4.!!
!
!
!
!!!!!Figure!5.!!!! !
!
!
!
Figure!6.!!
*
*
Stop*using*the*splint*if*you*have:*
• Swelling!of!the!weaker!arm,!or!!
• An!allergic!reaction!producing!redness,!itching,!burning!or!
!
!
other!skin!problems,!or!
• Find!the!splint!uncomfortable,!or!
• Have!an!open!wound!that!would!come!in!contact!with!the!
!
!
splint.!
If!you!have!any!of!these!problems,!please!also!contact!the!
researcher,!Chih9Huang!(Jeffrey)!Yu,!immediately!at!(425)998595517.!!
!
Care*and*cleaning:**
• Please!hand!wash!the!splint!in!warm%water%and%mild%soap!as!needed.!!
• Do*not*wring.!Lay!flat!on!towel.!!Dry!at!room!temperature.!Be!sure!the!material!is!completely!dry!
before!reapplying.!!
• Do*not*use*ointments*or*oils!under!the!material.!!