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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Low Movement Dose, 3200 Total Reps   Medium Movement Dose, 6400 Total Reps   High Movement Dose, 9600 Total Reps   Individual Maximum High Movement Dose
STARTED   21   22   21   21 
COMPLETED   20   21   21   20 
NOT COMPLETED   1   1   0   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Low Movement Dose, 3200 Total Reps   Medium Movement Dose, 6400 Total Reps   High Movement Dose, 9600 Total Reps   Individual Maximum High Movement Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   21   21   20   82 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.9  (12.8)   62.1  (8.6)   60.0  (8.3)   60.9  (13.4)   60.7  (10.8) 
Gender 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
         
Race           
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 
[Units: Participants]
         
United States   20   21   21   20   82 
Dominant side 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Months]
Median (Full Range)
 12 
 (6 to 180) 
 13 
 (6 to 221) 
 13 
 (6 to 54) 
 11.5 
 (6 to 144) 
 12.5 
 (6 to 221) 


  Outcome Measures

1.  Primary:   Change in Action Research Arm Test (ARAT) Score Per Week   [ Time Frame: 9 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: langc@wustl.edu


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