StrokeNCT01987414

Forearm Rotation Orthosis for Stroke

A study testing occupational therapy task-oriented approach, Forearm rotation orthosis and No treatment in people with Stroke, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm. Hypotheses of this study are: 1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: occupational therapy task-oriented approach, Forearm rotation orthosis and No treatment
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of stroke for at least three months
Be 18 years of age or older
Have sufficient cognitive function to follow three-step verbal instruction and provide independent consent
Have appropriate trunk and lower extremity function that does not interfere with performance of the upper extremity
Have at least minimum voluntary movement in the upper extremity (10 degrees of shoulder flex/ abduction, 10 degrees of elbow flexion/extension)
Not receive any rehabilitative interventions concurrent with the study

Who cannot join

Severe joint deformities or contractures of the affected upper extremity that limit range of motion required for functional tasks
Capability of voluntarily extending the wrist and fingers through the full range
Other rehabilitation interventions concurrent with the study
Have serious uncontrolled medical problems, such as seizures and visual impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Rehabilitation Building, University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm

Hypotheses of this study are:

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;
all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

Read the detailed description

Persons with central nervous system (CNS) dysfunction often have difficulty incorporating their affected limb effectively and efficiently into functional tasks due to muscle weakness and/or spasticity. This may further interfere with their performance of everyday activities and restrict life roles. Traditional rehabilitation interventions emphasize spasticity reduction. However, active movement and muscle strength of forearm supination are found strongly related to motor function, rather than spasticity. In contrast, task-oriented movement training trials have demonstrated promising evidence that persons with CNS dysfunction benefit from the training in improvement of motor function and increase functional use of the affected limb.

Orthotic intervention is one therapeutic option for this population. Most orthotic designs for this population are static, developed for sympton reduction or deformity prevention, and aimed at the wrist and hand. However, its effects on spasticity reduction remain controversial. Given that static orthotics may interfere with functional performance and further develop the learned nonuse of the affected limb, a dynamic or mobilization orthosis would be appropriate for enhancing functional performance. Moreover, an orthosis that assists forearm rotation is speculated to enhance functional performance. This study will examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm.

Conditions: Stroke
Being tested: occupational therapy task-oriented approach, Forearm rotation orthosis, No treatment
Keywords: Stroke, Cardiovascular Accident, Task-oriented approach, Orthosis, occupational therapy
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

occupational therapy task-oriented approachBehavioural
Also called OT task-oriented approach
It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
Forearm rotation orthosisDevice
The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.
No treatmentOther
Also called control
Participants will maintain their daily routines during the no treatment period.

Study groups in NCT01987414
Study group	Role	What they receive
Group A	Experimental	Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks) Receives: Behavioral: occupational therapy task-oriented approach; Device: Forearm rotation orthosis
Group B	Active comparator	no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks) Receives: Behavioral: occupational therapy task-oriented approach; Other: No treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Canadian Occupational Performance Measure (COPM) - Performance
Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Canadian Occupational Performance Measure (COPM) - Satisfaction
Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Wolf Motor Function Test (WMFT) - Time
This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. The number of seconds required to complete the task is recorded. If the participant exceeds 120 seconds, no additional time will be added and 120 seconds will be recorded. The total score is calculated as a mean of score (in seconds) from the 15 tasks. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Wolf Motor Function Test (WMFT) - Function
This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. Participants are scored on their ease of completing each task. Scores range from 1 to 3, with higher scores representing greater ease of task completion. The total score is mean value of the 15 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Motor Activity Log (MAL) - Amount of Use
This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how often they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normally use non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Motor Activity Log (MAL) - How Well
This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how well they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normal use of non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15

Secondary outcomes (15)

Goniometric Measurements - Shoulder Flexion
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Goniometric Measurements - Shoulder Abduction
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Goniometric Measurements - Elbow Extension
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Goniometric Measurements - Forearm Pronation
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Goniometric Measurements - Forearm Supination
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Goniometric Measurements - Wrist Extension
A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Shoulder Flexion
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Shoulder Abduction
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Elbow Extension
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Forearm Pronation
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Forearm Supination
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Wrist Extension
A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Grip
A Jamar Dynamometer will be used to measure grip strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Palmar Pinch
A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15
Upper Extremity Strength - Lateral Pinch
A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Measured: Week 1, 8, and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Jun 2018

First posted19 Nov 2013 (estimated)
Study startAug 2015
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01987414
Sponsor's protocol ID: 1309M42881
Status last verified: Sep 2019
First submitted: 29 Oct 2013
Last updated: 6 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Information gathered from outcome measures will be shared with other researchers at request. Study PI will seek approval from IRB at the University of Minnesota for means of sharing. Researchers will need to contact the study PI to obtain the information.

Publications

Braendvik SM, Elvrum AK, Vereijken B, Roeleveld K. Relationship between neuromuscular body functions and upper extremity activity in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e29-34. doi: 10.1111/j.1469-8749.2009.03490.x. Epub 2009 Oct 7.
PubMed 19811515
O'Dwyer NJ, Ada L, Neilson PD. Spasticity and muscle contracture following stroke. Brain. 1996 Oct;119 ( Pt 5):1737-49. doi: 10.1093/brain/119.5.1737.
PubMed 8931594
Dunning K, Berberich A, Albers B, Mortellite K, Levine PG, Hill Hermann VA, Page SJ. A four-week, task-specific neuroprosthesis program for a person with no active wrist or finger movement because of chronic stroke. Phys Ther. 2008 Mar;88(3):397-405. doi: 10.2522/ptj.20070087. Epub 2008 Jan 10.
PubMed 18187493
Page SJ, Levine P, Leonard AC. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2005 Mar;19(1):27-32. doi: 10.1177/1545968304272701.
PubMed 15673841
Page SJ, Levine P, Leonard A, Szaflarski JP, Kissela BM. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Phys Ther. 2008 Mar;88(3):333-40. doi: 10.2522/ptj.20060029. Epub 2008 Jan 3.
PubMed 18174447
Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.
PubMed 16514097
Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. doi: 10.1097/01.phm.0000141130.58285.da.
PubMed 15448577
Lannin NA, Horsley SA, Herbert R, McCluskey A, Cusick A. Splinting the hand in the functional position after brain impairment: a randomized, controlled trial. Arch Phys Med Rehabil. 2003 Feb;84(2):297-302. doi: 10.1053/apmr.2003.50031.
PubMed 12601664
Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
PubMed 11994754
Gillen G. Upper extremity function and management. In G. Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 218-279). St. Louis: Mosby, 2011.
Milazzo S, Gillen G. Splinting applications. In G Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 326-349). St. Louis: Mosby, 2011
Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.
PubMed 18077218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm
ClinicalTrials.gov ID: NCT01987414
Acronym / sponsor ID: 1309M42881
Conditions: Stroke
Keywords: Stroke, Cardiovascular Accident, Task-oriented approach, Orthosis, occupational therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: Aug 2015 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 19 Nov 2013 (estimated)
Results: Posted 6 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypotheses of this study are:

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;
all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Behavioral: occupational therapy task-oriented approach, Device: Forearm rotation orthosisForearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
Group B	Active comparator	Behavioral: occupational therapy task-oriented approach, Other: No treatmentno treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Have a diagnosis of stroke for at least three months
Be 18 years of age or older
Have sufficient cognitive function to follow three-step verbal instruction and provide independent consent
Have appropriate trunk and lower extremity function that does not interfere with performance of the upper extremity
Have at least minimum voluntary movement in the upper extremity (10 degrees of shoulder flex/ abduction, 10 degrees of elbow flexion/extension)

Key exclusion criteria (4 listed)

Severe joint deformities or contractures of the affected upper extremity that limit range of motion required for functional tasks
Capability of voluntarily extending the wrist and fingers through the full range
Other rehabilitation interventions concurrent with the study
Have serious uncontrolled medical problems, such as seizures and visual impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
occupational therapy task-oriented approachAlso: OT task-oriented approachIt is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.	Behavioural	Group A, Group B
Forearm rotation orthosisThe forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.	Device	Group A
No treatmentAlso: controlParticipants will maintain their daily routines during the no treatment period.	Other	Group B

Primary outcome

Canadian Occupational Performance Measure (COPM) - Performance
Time frame: Week 1, 8, and 15
Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Canadian Occupational Performance Measure (COPM) - Satisfaction
Time frame: Week 1, 8, and 15
Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Wolf Motor Function Test (WMFT) - Time
Time frame: Week 1, 8, and 15
This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. The number of seconds required to complete the task is recorded. If the participant exceeds 120 seconds, no additional time will be added and 120 seconds will be recorded. The total score is calculated as a mean of score (in seconds) from the 15 tasks. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Wolf Motor Function Test (WMFT) - Function
Time frame: Week 1, 8, and 15
This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. Participants are scored on their ease of completing each task. Scores range from 1 to 3, with higher scores representing greater ease of task completion. The total score is mean value of the 15 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Motor Activity Log (MAL) - Amount of Use
Time frame: Week 1, 8, and 15
This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how often they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normally use non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.
Motor Activity Log (MAL) - How Well
Time frame: Week 1, 8, and 15
This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how well they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normal use of non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.

15 secondary outcomes

Goniometric Measurements - Shoulder Flexion
Time frame: Week 1, 8, and 15
Goniometric Measurements - Shoulder Abduction
Time frame: Week 1, 8, and 15
Goniometric Measurements - Elbow Extension
Time frame: Week 1, 8, and 15
Goniometric Measurements - Forearm Pronation
Time frame: Week 1, 8, and 15
Goniometric Measurements - Forearm Supination
Time frame: Week 1, 8, and 15
Goniometric Measurements - Wrist Extension
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Shoulder Flexion
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Shoulder Abduction
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Elbow Extension
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Forearm Pronation
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Forearm Supination
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Wrist Extension
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Grip
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Palmar Pinch
Time frame: Week 1, 8, and 15
Upper Extremity Strength - Lateral Pinch
Time frame: Week 1, 8, and 15

Results and safety

Results posted to the registry on 6 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	10	8
Group B	8	6

Primary outcome: Canadian Occupational Performance Measure (COPM) - Performance

Time frame: Week 1, 8, and 15. Mean (Standard Deviation). Unit: score on a scale

Measure	Group A n = 8	Group B n = 6
Week 1 (Pre-test)	2.95 (.77)	3.77 (1.33)
Week 8 (Post-test 1)	3.3 (1.21)	3.43 (1.05)
Week 15 (Post-test 2)	5.8 (1.34)	5.98 (1.53)

Primary outcome: Canadian Occupational Performance Measure (COPM) - Satisfaction

Time frame: Week 1, 8, and 15. Mean (Standard Deviation). Unit: score on a scale

Measure	Group A n = 8	Group B n = 6
Week 1 (Pre-test)	2.73 (1.11)	3.17 (1.48)
Week 8 (Post-test 1)	3.18 (1.54)	3.1 (1.18)
Week 15 (Post-test 2)	5.93 (1.19)	5.65 (1.29)

Primary outcome: Wolf Motor Function Test (WMFT) - Time

Time frame: Week 1, 8, and 15. Mean (Standard Deviation). Unit: seconds

Measure	Group A n = 8	Group B n = 6
Week 1 (Pre-test)	66.25 (17.99)	40.38 (40.45)
Week 8 (Post-test 1)	63.25 (14.88)	39.15 (39.49)
Week 15 (Post-test 2)	61.41 (15.57)	44.65 (39.36)

Primary outcome: Wolf Motor Function Test (WMFT) - Function

Time frame: Week 1, 8, and 15. Mean (Standard Deviation). Unit: score on a scale

Measure	Group A n = 8	Group B n = 6
Week 1 (Pre-test)	2.07 (.35)	2.8 (.94)
Week 8 (Post-test 1)	2.16 (.41)	2.77 (1.33)
Week 15 (Post-test 2)	2.16 (.36)	2.9 (1.33)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Group B	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19811515Braendvik SM, Elvrum AK, Vereijken B, Roeleveld K. Relationship between neuromuscular body functions and upper extremity activity in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e29-34. doi: 10.1111/j.1469-8749.2009.03490.x. Epub 2009 Oct 7.
Background: PubMed 8931594O'Dwyer NJ, Ada L, Neilson PD. Spasticity and muscle contracture following stroke. Brain. 1996 Oct;119 ( Pt 5):1737-49. doi: 10.1093/brain/119.5.1737.
Background: PubMed 18187493Dunning K, Berberich A, Albers B, Mortellite K, Levine PG, Hill Hermann VA, Page SJ. A four-week, task-specific neuroprosthesis program for a person with no active wrist or finger movement because of chronic stroke. Phys Ther. 2008 Mar;88(3):397-405. doi: 10.2522/ptj.20070087. Epub 2008 Jan 10.
Background: PubMed 15673841Page SJ, Levine P, Leonard AC. Modified constraint-induced therapy in acute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2005 Mar;19(1):27-32. doi: 10.1177/1545968304272701.
Background: PubMed 18174447Page SJ, Levine P, Leonard A, Szaflarski JP, Kissela BM. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Phys Ther. 2008 Mar;88(3):333-40. doi: 10.2522/ptj.20060029. Epub 2008 Jan 3.
Background: PubMed 16514097Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.
Background: PubMed 15448577Watanabe T. The role of therapy in spasticity management. Am J Phys Med Rehabil. 2004 Oct;83(10 Suppl):S45-9. doi: 10.1097/01.phm.0000141130.58285.da.
Background: PubMed 12601664Lannin NA, Horsley SA, Herbert R, McCluskey A, Cusick A. Splinting the hand in the functional position after brain impairment: a randomized, controlled trial. Arch Phys Med Rehabil. 2003 Feb;84(2):297-302. doi: 10.1053/apmr.2003.50031.
Background: PubMed 11994754Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
BackgroundGillen G. Upper extremity function and management. In G. Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 218-279). St. Louis: Mosby, 2011.
BackgroundMilazzo S, Gillen G. Splinting applications. In G Gillen (Ed.), Stroke rehabilitation: A function-based approach (3rd ed., pp. 326-349). St. Louis: Mosby, 2011
Background: PubMed 18077218Wolf SL, Winstein CJ, Miller JP, Thompson PA, Taub E, Uswatte G, Morris D, Blanton S, Nichols-Larsen D, Clark PC. Retention of upper limb function in stroke survivors who have received constraint-induced movement therapy: the EXCITE randomised trial. Lancet Neurol. 2008 Jan;7(1):33-40. doi: 10.1016/S1474-4422(07)70294-6.
Individual participant dataSharing planned: No. Information gathered from outcome measures will be shared with other researchers at request. Study PI will seek approval from IRB at the University of Minnesota for means of sharing. Researchers will need to contact the study PI to obtain the information.

Related trials for Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chih-Huang Yu, MS principal investigator

Rehabilitation Science Program at the University of Minnesota

Virgil Mathiowetz, PhD study director

Program in Occupational Therapy, University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing occupational therapy task-oriented approach, Forearm rotation orthosis and No treatment in people with Stroke, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (COPM) - Performance (time frame: Week 1, 8, and 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987414, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.