Trial Outcomes & Findings for Does More Practice Improve Arm Movement After Stroke? (NCT NCT01146379)
NCT ID: NCT01146379
Last Updated: 2017-02-24
Results Overview
The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
9 weeks
Results posted on
2017-02-24
Participant Flow
Participant milestones
| Measure |
Low Movement Dose, 3200 Total Reps
Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Medium Movement Dose, 6400 Total Reps
Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
High Movement Dose, 9600 Total Reps
Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Individual Maximum High Movement Dose
Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
21
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does More Practice Improve Arm Movement After Stroke?
Baseline characteristics by cohort
| Measure |
Low Movement Dose, 3200 Total Reps
n=20 Participants
Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Medium Movement Dose, 6400 Total Reps
n=21 Participants
Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
High Movement Dose, 9600 Total Reps
n=21 Participants
Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Individual Maximum High Movement Dose
n=20 Participants
Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Gender
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Non-caucasian
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
20 participants
n=4 Participants
|
82 participants
n=21 Participants
|
|
Dominant side
Right
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Dominant side
Left
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Affected side
Right
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Affected side
Left
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Time since stroke
|
12 months
n=5 Participants
|
13 months
n=7 Participants
|
13 months
n=5 Participants
|
11.5 months
n=4 Participants
|
12.5 months
n=21 Participants
|
PRIMARY outcome
Timeframe: 9 weeksThe Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.
Outcome measures
| Measure |
Low Movement Dose, 3200 Total Reps
n=20 Participants
Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Medium Movement Dose, 6400 Total Reps
n=21 Participants
Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
High Movement Dose, 9600 Total Reps
n=21 Participants
Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
Individual Maximum High Movement Dose
n=20 Participants
Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
|
|---|---|---|---|---|
|
Change in Action Research Arm Test (ARAT) Score Per Week
|
0.4 change in units on a scale/week
Standard Error 0.15
|
-0.05 change in units on a scale/week
Standard Error 0.21
|
0.31 change in units on a scale/week
Standard Error 0.22
|
0.66 change in units on a scale/week
Standard Error 0.20
|
Adverse Events
Low Movement Dose, 3200 Total Reps
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Movement Dose, 6400 Total Reps
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Movement Dose, 9600 Total Reps
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Maximum High Movement Dose
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
Dr. Catherine Lang
Washington University School of Medicine
Phone: 314-286-1945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place