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Forearm Rotation Orthosis for Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987414
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Interventions Behavioral: occupational therapy task-oriented approach
Device: Forearm rotation orthosis
Other: No treatment
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 10 8
Completed 8 6
Not Completed 2 2
Arm/Group Title Group A Group B Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 8 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
5
  83.3%
13
  92.9%
>=65 years
0
   0.0%
1
  16.7%
1
   7.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 8 participants 6 participants 14 participants
53.88  (11.99) 58.5  (10.17) 55.86  (11.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Female
2
  25.0%
1
  16.7%
3
  21.4%
Male
6
  75.0%
5
  83.3%
11
  78.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  25.0%
0
   0.0%
2
  14.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
  75.0%
6
 100.0%
12
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 14 participants
8 6 14
1.Primary Outcome
Title Canadian Occupational Performance Measure (COPM) - Performance
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
2.Primary Outcome
Title Canadian Occupational Performance Measure (COPM) - Satisfaction
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
3.Primary Outcome
Title Wolf Motor Function Test (WMFT) - Time
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: seconds
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)
4.Primary Outcome
Title Wolf Motor Function Test (WMFT) - Function
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
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)
5.Primary Outcome
Title Motor Activity Log (MAL) - Amount of Use
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 1 (Pre-test) .46  (.42) 1.06  (.85)
Week 8 (Post-test 1) .56  (.57) 1.01  (.96)
Week 15 (Post-test 2) .81  (.64) 1.61  (1.22)
6.Primary Outcome
Title Motor Activity Log (MAL) - How Well
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 (Pre-test) .52  (.47) 1.15  (.75)
Week 8 (Post-test 1) .56  (.54) 1.18  (1.19)
Week 15 (Post-test 2) .86  (.66) 1.63  (1.2)
7.Secondary Outcome
Title Goniometric Measurements - Shoulder Flexion
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: degrees
Week 1 (Pre-test) 103.5  (30.56) 99  (41.91)
Week 8 (Post-test 1) 92.75  (33.52) 93  (29.15)
Week 15 (Post-test 2) 100.38  (38.06) 96  (29.5)
8.Secondary Outcome
Title Goniometric Measurements - Shoulder Abduction
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: degrees
Week 1 (Pre-test) 96  (33.56) 95.17  (32.33)
Week 8 (Post-test 1) 85.75  (25.27) 87.83  (26.28)
Week 15 (Post-test 2) 87.75  (31.35) 90.33  (27.34)
9.Secondary Outcome
Title Goniometric Measurements - Elbow Extension
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: degrees
Week 1 (Pre-test) 117.25  (17.52) 103.67  (33.21)
Week 8 (Post-test 1) 113.13  (21.01) 97.5  (21.36)
Week 15 (Post-test 2) 125.25  (10.31) 119.83  (30.22)
10.Secondary Outcome
Title Goniometric Measurements - Forearm Pronation
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: degrees
Week 1 (Pre-test) 63.13  (19.14) 67.67  (16.81)
Week 8 (Post-test 1) 61.63  (30.42) 64  (27.94)
Week 15 (Post-test 2) 65.63  (23.37) 59.17  (18.28)
11.Secondary Outcome
Title Goniometric Measurements - Forearm Supination
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: degrees
Week 1 (Pre-test) 38  (29.89) 51.33  (24.87)
Week 8 (Post-test 1) 38.13  (29.92) 47.5  (33.58)
Week 15 (Post-test 2) 55.13  (27.48) 53.33  (27.14)
12.Secondary Outcome
Title Goniometric Measurements - Wrist Extension
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: degrees
Week 1 (Pre-test) 20.25  (17.5) 36.67  (19.4)
Week 8 (Post-test 1) 23.13  (19.81) 40.38  (22.71)
Week 15 (Post-test 2) 26.25  (21.67) 39.17  (22.23)
13.Secondary Outcome
Title Upper Extremity Strength - Shoulder Flexion
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 14.91  (7.01) 14.48  (6.99)
Week 8 (Post-test 1) 15.13  (5.3) 18.06  (11.53)
Week 15 (Post-test 2) 17.36  (10.08) 21.13  (15.22)
14.Secondary Outcome
Title Upper Extremity Strength - Shoulder Abduction
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 15.1  (6.24) 17.82  (10.69)
Week 8 (Post-test 1) 15.32  (6.57) 16.99  (11.73)
Week 15 (Post-test 2) 17.65  (9.7) 18.68  (13.61)
15.Secondary Outcome
Title Upper Extremity Strength - Elbow Extension
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 12.9  (5.27) 13.97  (7.77)
Week 8 (Post-test 1) 11.98  (3.13) 16.43  (7.81)
Week 15 (Post-test 2) 12.81  (6.62) 17.56  (10.46)
16.Secondary Outcome
Title Upper Extremity Strength - Forearm Pronation
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 10.83  (4.99) 11.87  (5.49)
Week 8 (Post-test 1) 10.97  (3.6) 11.51  (6.3)
Week 15 (Post-test 2) 11.74  (6.29) 11.98  (9.96)
17.Secondary Outcome
Title Upper Extremity Strength - Forearm Supination
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 6.06  (4.86) 7.74  (3.74)
Week 8 (Post-test 1) 5.76  (3.56) 6.58  (3.12)
Week 15 (Post-test 2) 6.3  (3.36) 8.15  (3.74)
18.Secondary Outcome
Title Upper Extremity Strength - Wrist Extension
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 8.72  (6.13) 11.98  (7.2)
Week 8 (Post-test 1) 8.38  (5.76) 15.2  (11.59)
Week 15 (Post-test 2) 9.74  (6.17) 14.79  (11.31)
19.Secondary Outcome
Title Upper Extremity Strength - Grip
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 13.21  (7.06) 29.39  (18.83)
Week 8 (Post-test 1) 13.77  (9.62) 28.5  (22.33)
Week 15 (Post-test 2) 17.38  (6.79) 28.55  (17.76)
20.Secondary Outcome
Title Upper Extremity Strength - Palmar Pinch
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) .67  (1.28) 6.06  (6.5)
Week 8 (Post-test 1) .88  (1.1) 4.95  (6.71)
Week 15 (Post-test 2) 1.17  (1.73) 5.11  (5.78)
21.Secondary Outcome
Title Upper Extremity Strength - Lateral Pinch
Hide Description 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.
Time Frame Week 1, 8, and 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 6
Mean (Standard Deviation)
Unit of Measure: lbs
Week 1 (Pre-test) 6.94  (3.71) 17.72  (12.61)
Week 8 (Post-test 1) 7.32  (4.82) 16.72  (14.28)
Week 15 (Post-test 2) 9.27  (3.53) 16.84  (11.13)
Time Frame 15 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chih-Huang Yu
Organization: University of Minnesota
Phone: 6126262443
EMail: yuxxx648@umn.edu
Publications:
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
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01987414    
Other Study ID Numbers: 1309M42881
First Submitted: October 29, 2013
First Posted: November 19, 2013
Results First Submitted: August 6, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019