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Does More Practice Improve Arm Movement After Stroke?

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ClinicalTrials.gov Identifier: NCT01146379
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Catherine E. Lang, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stroke
Intervention Other: Intensive task-specific upper extremity rehabilitation
Enrollment 85
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 21 22 21 21
Completed 20 21 21 20
Not Completed 1 1 0 1
Arm/Group Title Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 20 21 21 20 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
59.9  (12.8) 62.1  (8.6) 60.0  (8.3) 60.9  (13.4) 60.7  (10.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
Female
7
  35.0%
5
  23.8%
10
  47.6%
8
  40.0%
30
  36.6%
Male
13
  65.0%
16
  76.2%
11
  52.4%
12
  60.0%
52
  63.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
Caucasian
10
  50.0%
11
  52.4%
10
  47.6%
11
  55.0%
42
  51.2%
Non-caucasian
10
  50.0%
10
  47.6%
11
  52.4%
9
  45.0%
40
  48.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
20 21 21 20 82
Dominant side  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
Right
18
  90.0%
16
  76.2%
19
  90.5%
18
  90.0%
71
  86.6%
Left
2
  10.0%
5
  23.8%
2
   9.5%
2
  10.0%
11
  13.4%
Affected side  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
Right
11
  55.0%
10
  47.6%
10
  47.6%
13
  65.0%
44
  53.7%
Left
9
  45.0%
11
  52.4%
11
  52.4%
7
  35.0%
38
  46.3%
Time since stroke  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants 21 participants 21 participants 20 participants 82 participants
12
(6 to 180)
13
(6 to 221)
13
(6 to 54)
11.5
(6 to 144)
12.5
(6 to 221)
1.Primary Outcome
Title Change in Action Research Arm Test (ARAT) Score Per Week
Hide Description 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.
Time Frame 9 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 20 21 21 20
Mean (Standard Error)
Unit of Measure: change in units on a scale/week
0.4  (0.15) -0.05  (0.21) 0.31  (0.22) 0.66  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Movement Dose, 3200 Total Reps, Medium Movement Dose, 6400 Total Reps, High Movement Dose, 9600 Total Reps, Individual Maximum High Movement Dose
Comments The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Movement Dose, 3200 Total Reps, Medium Movement Dose, 6400 Total Reps
Comments This analysis then asked which groups were different from the Low Movement Dose group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .036
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Low Movement Dose, 3200 Total Reps, High Movement Dose, 9600 Total Reps
Comments This analysis asked if the Low Movement Dose group was different from the High Movement Dose group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.679
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Low Movement Dose, 3200 Total Reps, Individual Maximum High Movement Dose
Comments This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%)   0/21 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Movement Dose, 3200 Total Reps Medium Movement Dose, 6400 Total Reps High Movement Dose, 9600 Total Reps Individual Maximum High Movement Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%)   0/21 (0.00%)   0/20 (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
Name/Title: Dr. Catherine Lang
Organization: Washington University School of Medicine
Phone: 314-286-1945
Publications:
Responsible Party: Catherine E. Lang, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01146379     History of Changes
Other Study ID Numbers: 10-0230
First Submitted: June 3, 2010
First Posted: June 17, 2010
Results First Submitted: October 31, 2016
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017