N/A
N=18
Forearm Rotation Orthosis for Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01987414 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Canadian Occupational Performance Measure (COPM) - Performance — 2.95; 3.77; 3.3; 3.43 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- occupational therapy task-oriented approach (Behavioral); Forearm rotation orthosis (Device); No treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Canadian Occupational Performance Measure (COPM) - Performance |
2.95; 3.77; 3.3; 3.43; 5.8; 5.98 | — |
| PRIMARY Canadian Occupational Performance Measure (COPM) - Satisfaction |
2.73; 3.17; 3.18; 3.1; 5.93; 5.65 | — |
| PRIMARY Wolf Motor Function Test (WMFT) - Time |
66.25; 40.38; 63.25; 39.15; 61.41; 44.65 | — |
| PRIMARY Wolf Motor Function Test (WMFT) - Function |
2.07; 2.8; 2.16; 2.77; 2.16; 2.9 | — |
| PRIMARY Motor Activity Log (MAL) - Amount of Use |
.46; 1.06; .56; 1.01; .81; 1.61 | — |
| PRIMARY Motor Activity Log (MAL) - How Well |
.52; 1.15; .56; 1.18; .86; 1.63 | — |
| SECONDARY Goniometric Measurements - Shoulder Flexion |
103.5; 99; 92.75; 93; 100.38; 96 | — |
| SECONDARY Goniometric Measurements - Shoulder Abduction |
96; 95.17; 85.75; 87.83; 87.75; 90.33 | — |
| SECONDARY Goniometric Measurements - Elbow Extension |
117.25; 103.67; 113.13; 97.5; 125.25; 119.83 | — |
| SECONDARY Goniometric Measurements - Forearm Pronation |
63.13; 67.67; 61.63; 64; 65.63; 59.17 | — |
| SECONDARY Goniometric Measurements - Forearm Supination |
38; 51.33; 38.13; 47.5; 55.13; 53.33 | — |
| SECONDARY Goniometric Measurements - Wrist Extension |
20.25; 36.67; 23.13; 40.38; 26.25; 39.17 | — |
| SECONDARY Upper Extremity Strength - Shoulder Flexion |
14.91; 14.48; 15.13; 18.06; 17.36; 21.13 | — |
| SECONDARY Upper Extremity Strength - Shoulder Abduction |
15.1; 17.82; 15.32; 16.99; 17.65; 18.68 | — |
| SECONDARY Upper Extremity Strength - Elbow Extension |
12.9; 13.97; 11.98; 16.43; 12.81; 17.56 | — |
| SECONDARY Upper Extremity Strength - Forearm Pronation |
10.83; 11.87; 10.97; 11.51; 11.74; 11.98 | — |
| SECONDARY Upper Extremity Strength - Forearm Supination |
6.06; 7.74; 5.76; 6.58; 6.3; 8.15 | — |
| SECONDARY Upper Extremity Strength - Wrist Extension |
8.72; 11.98; 8.38; 15.2; 9.74; 14.79 | — |
| SECONDARY Upper Extremity Strength - Grip |
13.21; 29.39; 13.77; 28.5; 17.38; 28.55 | — |
| SECONDARY Upper Extremity Strength - Palmar Pinch |
.67; 6.06; .88; 4.95; 1.17; 5.11 | — |
| SECONDARY Upper Extremity Strength - Lateral Pinch |
6.94; 17.72; 7.32; 16.72; 9.27; 16.84 | — |
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. 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 occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
3. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01987414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.