Trial Outcomes & Findings for Forearm Rotation Orthosis for Stroke (NCT NCT01987414)
NCT ID: NCT01987414
Last Updated: 2019-09-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Week 1, 8, and 15
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Group A
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Forearm Rotation Orthosis for Stroke
Baseline characteristics by cohort
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
53.88 year
STANDARD_DEVIATION 11.99 • n=5 Participants
|
58.5 year
STANDARD_DEVIATION 10.17 • n=7 Participants
|
55.86 year
STANDARD_DEVIATION 11.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1, 8, and 15Used 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) - Performance
Week 1 (Pre-test)
|
2.95 score on a scale
Standard Deviation .77
|
3.77 score on a scale
Standard Deviation 1.33
|
|
Canadian Occupational Performance Measure (COPM) - Performance
Week 8 (Post-test 1)
|
3.3 score on a scale
Standard Deviation 1.21
|
3.43 score on a scale
Standard Deviation 1.05
|
|
Canadian Occupational Performance Measure (COPM) - Performance
Week 15 (Post-test 2)
|
5.8 score on a scale
Standard Deviation 1.34
|
5.98 score on a scale
Standard Deviation 1.53
|
PRIMARY outcome
Timeframe: Week 1, 8, and 15Used 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) - Satisfaction
Week 1 (Pre-test)
|
2.73 score on a scale
Standard Deviation 1.11
|
3.17 score on a scale
Standard Deviation 1.48
|
|
Canadian Occupational Performance Measure (COPM) - Satisfaction
Week 8 (Post-test 1)
|
3.18 score on a scale
Standard Deviation 1.54
|
3.1 score on a scale
Standard Deviation 1.18
|
|
Canadian Occupational Performance Measure (COPM) - Satisfaction
Week 15 (Post-test 2)
|
5.93 score on a scale
Standard Deviation 1.19
|
5.65 score on a scale
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: Week 1, 8, and 15This 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) - Time
Week 1 (Pre-test)
|
66.25 seconds
Standard Deviation 17.99
|
40.38 seconds
Standard Deviation 40.45
|
|
Wolf Motor Function Test (WMFT) - Time
Week 8 (Post-test 1)
|
63.25 seconds
Standard Deviation 14.88
|
39.15 seconds
Standard Deviation 39.49
|
|
Wolf Motor Function Test (WMFT) - Time
Week 15 (Post-test 2)
|
61.41 seconds
Standard Deviation 15.57
|
44.65 seconds
Standard Deviation 39.36
|
PRIMARY outcome
Timeframe: Week 1, 8, and 15This 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) - Function
Week 1 (Pre-test)
|
2.07 score on a scale
Standard Deviation .35
|
2.8 score on a scale
Standard Deviation .94
|
|
Wolf Motor Function Test (WMFT) - Function
Week 8 (Post-test 1)
|
2.16 score on a scale
Standard Deviation .41
|
2.77 score on a scale
Standard Deviation 1.33
|
|
Wolf Motor Function Test (WMFT) - Function
Week 15 (Post-test 2)
|
2.16 score on a scale
Standard Deviation .36
|
2.9 score on a scale
Standard Deviation 1.33
|
PRIMARY outcome
Timeframe: Week 1, 8, and 15This 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Motor Activity Log (MAL) - Amount of Use
Week 1 (Pre-test)
|
.46 score on a scale
Standard Deviation .42
|
1.06 score on a scale
Standard Deviation .85
|
|
Motor Activity Log (MAL) - Amount of Use
Week 8 (Post-test 1)
|
.56 score on a scale
Standard Deviation .57
|
1.01 score on a scale
Standard Deviation .96
|
|
Motor Activity Log (MAL) - Amount of Use
Week 15 (Post-test 2)
|
.81 score on a scale
Standard Deviation .64
|
1.61 score on a scale
Standard Deviation 1.22
|
PRIMARY outcome
Timeframe: Week 1, 8, and 15This 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Motor Activity Log (MAL) - How Well
Week 1 (Pre-test)
|
.52 units on a scale
Standard Deviation .47
|
1.15 units on a scale
Standard Deviation .75
|
|
Motor Activity Log (MAL) - How Well
Week 8 (Post-test 1)
|
.56 units on a scale
Standard Deviation .54
|
1.18 units on a scale
Standard Deviation 1.19
|
|
Motor Activity Log (MAL) - How Well
Week 15 (Post-test 2)
|
.86 units on a scale
Standard Deviation .66
|
1.63 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Goniometric Measurements - Shoulder Flexion
Week 1 (Pre-test)
|
103.5 degrees
Standard Deviation 30.56
|
99 degrees
Standard Deviation 41.91
|
|
Goniometric Measurements - Shoulder Flexion
Week 8 (Post-test 1)
|
92.75 degrees
Standard Deviation 33.52
|
93 degrees
Standard Deviation 29.15
|
|
Goniometric Measurements - Shoulder Flexion
Week 15 (Post-test 2)
|
100.38 degrees
Standard Deviation 38.06
|
96 degrees
Standard Deviation 29.5
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Goniometric Measurements - Shoulder Abduction
Week 1 (Pre-test)
|
96 degrees
Standard Deviation 33.56
|
95.17 degrees
Standard Deviation 32.33
|
|
Goniometric Measurements - Shoulder Abduction
Week 8 (Post-test 1)
|
85.75 degrees
Standard Deviation 25.27
|
87.83 degrees
Standard Deviation 26.28
|
|
Goniometric Measurements - Shoulder Abduction
Week 15 (Post-test 2)
|
87.75 degrees
Standard Deviation 31.35
|
90.33 degrees
Standard Deviation 27.34
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Goniometric Measurements - Elbow Extension
Week 1 (Pre-test)
|
117.25 degrees
Standard Deviation 17.52
|
103.67 degrees
Standard Deviation 33.21
|
|
Goniometric Measurements - Elbow Extension
Week 8 (Post-test 1)
|
113.13 degrees
Standard Deviation 21.01
|
97.5 degrees
Standard Deviation 21.36
|
|
Goniometric Measurements - Elbow Extension
Week 15 (Post-test 2)
|
125.25 degrees
Standard Deviation 10.31
|
119.83 degrees
Standard Deviation 30.22
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Goniometric Measurements - Forearm Pronation
Week 1 (Pre-test)
|
63.13 degrees
Standard Deviation 19.14
|
67.67 degrees
Standard Deviation 16.81
|
|
Goniometric Measurements - Forearm Pronation
Week 8 (Post-test 1)
|
61.63 degrees
Standard Deviation 30.42
|
64 degrees
Standard Deviation 27.94
|
|
Goniometric Measurements - Forearm Pronation
Week 15 (Post-test 2)
|
65.63 degrees
Standard Deviation 23.37
|
59.17 degrees
Standard Deviation 18.28
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Goniometric Measurements - Forearm Supination
Week 1 (Pre-test)
|
38 degrees
Standard Deviation 29.89
|
51.33 degrees
Standard Deviation 24.87
|
|
Goniometric Measurements - Forearm Supination
Week 8 (Post-test 1)
|
38.13 degrees
Standard Deviation 29.92
|
47.5 degrees
Standard Deviation 33.58
|
|
Goniometric Measurements - Forearm Supination
Week 15 (Post-test 2)
|
55.13 degrees
Standard Deviation 27.48
|
53.33 degrees
Standard Deviation 27.14
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Goniometric Measurements - Wrist Extension
Week 1 (Pre-test)
|
20.25 degrees
Standard Deviation 17.5
|
36.67 degrees
Standard Deviation 19.4
|
|
Goniometric Measurements - Wrist Extension
Week 8 (Post-test 1)
|
23.13 degrees
Standard Deviation 19.81
|
40.38 degrees
Standard Deviation 22.71
|
|
Goniometric Measurements - Wrist Extension
Week 15 (Post-test 2)
|
26.25 degrees
Standard Deviation 21.67
|
39.17 degrees
Standard Deviation 22.23
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Shoulder Flexion
Week 1 (Pre-test)
|
14.91 lbs
Standard Deviation 7.01
|
14.48 lbs
Standard Deviation 6.99
|
|
Upper Extremity Strength - Shoulder Flexion
Week 8 (Post-test 1)
|
15.13 lbs
Standard Deviation 5.3
|
18.06 lbs
Standard Deviation 11.53
|
|
Upper Extremity Strength - Shoulder Flexion
Week 15 (Post-test 2)
|
17.36 lbs
Standard Deviation 10.08
|
21.13 lbs
Standard Deviation 15.22
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Shoulder Abduction
Week 1 (Pre-test)
|
15.1 lbs
Standard Deviation 6.24
|
17.82 lbs
Standard Deviation 10.69
|
|
Upper Extremity Strength - Shoulder Abduction
Week 8 (Post-test 1)
|
15.32 lbs
Standard Deviation 6.57
|
16.99 lbs
Standard Deviation 11.73
|
|
Upper Extremity Strength - Shoulder Abduction
Week 15 (Post-test 2)
|
17.65 lbs
Standard Deviation 9.7
|
18.68 lbs
Standard Deviation 13.61
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Elbow Extension
Week 1 (Pre-test)
|
12.9 lbs
Standard Deviation 5.27
|
13.97 lbs
Standard Deviation 7.77
|
|
Upper Extremity Strength - Elbow Extension
Week 8 (Post-test 1)
|
11.98 lbs
Standard Deviation 3.13
|
16.43 lbs
Standard Deviation 7.81
|
|
Upper Extremity Strength - Elbow Extension
Week 15 (Post-test 2)
|
12.81 lbs
Standard Deviation 6.62
|
17.56 lbs
Standard Deviation 10.46
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Forearm Pronation
Week 1 (Pre-test)
|
10.83 lbs
Standard Deviation 4.99
|
11.87 lbs
Standard Deviation 5.49
|
|
Upper Extremity Strength - Forearm Pronation
Week 8 (Post-test 1)
|
10.97 lbs
Standard Deviation 3.6
|
11.51 lbs
Standard Deviation 6.3
|
|
Upper Extremity Strength - Forearm Pronation
Week 15 (Post-test 2)
|
11.74 lbs
Standard Deviation 6.29
|
11.98 lbs
Standard Deviation 9.96
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Forearm Supination
Week 1 (Pre-test)
|
6.06 lbs
Standard Deviation 4.86
|
7.74 lbs
Standard Deviation 3.74
|
|
Upper Extremity Strength - Forearm Supination
Week 8 (Post-test 1)
|
5.76 lbs
Standard Deviation 3.56
|
6.58 lbs
Standard Deviation 3.12
|
|
Upper Extremity Strength - Forearm Supination
Week 15 (Post-test 2)
|
6.3 lbs
Standard Deviation 3.36
|
8.15 lbs
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Wrist Extension
Week 1 (Pre-test)
|
8.72 lbs
Standard Deviation 6.13
|
11.98 lbs
Standard Deviation 7.2
|
|
Upper Extremity Strength - Wrist Extension
Week 8 (Post-test 1)
|
8.38 lbs
Standard Deviation 5.76
|
15.2 lbs
Standard Deviation 11.59
|
|
Upper Extremity Strength - Wrist Extension
Week 15 (Post-test 2)
|
9.74 lbs
Standard Deviation 6.17
|
14.79 lbs
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Grip
Week 1 (Pre-test)
|
13.21 lbs
Standard Deviation 7.06
|
29.39 lbs
Standard Deviation 18.83
|
|
Upper Extremity Strength - Grip
Week 8 (Post-test 1)
|
13.77 lbs
Standard Deviation 9.62
|
28.5 lbs
Standard Deviation 22.33
|
|
Upper Extremity Strength - Grip
Week 15 (Post-test 2)
|
17.38 lbs
Standard Deviation 6.79
|
28.55 lbs
Standard Deviation 17.76
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Palmar Pinch
Week 1 (Pre-test)
|
.67 lbs
Standard Deviation 1.28
|
6.06 lbs
Standard Deviation 6.5
|
|
Upper Extremity Strength - Palmar Pinch
Week 8 (Post-test 1)
|
.88 lbs
Standard Deviation 1.1
|
4.95 lbs
Standard Deviation 6.71
|
|
Upper Extremity Strength - Palmar Pinch
Week 15 (Post-test 2)
|
1.17 lbs
Standard Deviation 1.73
|
5.11 lbs
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Week 1, 8, and 15A 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.
Outcome measures
| Measure |
Group A
n=8 Participants
Forearm rotation orthosis (6 weeks); Forearm rotation orthosis plus occupational therapy task-oriented approach (6 weeks)
occupational therapy 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 orthosis: 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.
|
Group B
n=6 Participants
no treatment (6 weeks); occupational therapy task-oriented approach (6 weeks)
occupational therapy 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.
No treatment: Participants will maintain their daily routines during the no treatment period.
|
|---|---|---|
|
Upper Extremity Strength - Lateral Pinch
Week 1 (Pre-test)
|
6.94 lbs
Standard Deviation 3.71
|
17.72 lbs
Standard Deviation 12.61
|
|
Upper Extremity Strength - Lateral Pinch
Week 8 (Post-test 1)
|
7.32 lbs
Standard Deviation 4.82
|
16.72 lbs
Standard Deviation 14.28
|
|
Upper Extremity Strength - Lateral Pinch
Week 15 (Post-test 2)
|
9.27 lbs
Standard Deviation 3.53
|
16.84 lbs
Standard Deviation 11.13
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place