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Influence of Timing on Motor Learning

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01769326
First received: November 16, 2012
Last updated: June 5, 2017
Last verified: June 2017
Results First Received: February 15, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Outcomes Assessor;   Primary Purpose: Treatment
Condition: Cerebrovascular Accident
Interventions: Other: Conventional hand exercise
Device: MusicGlove
Other: Conventional Arm Exercise
Device: Resonating Arm Exerciser

  Participant Flow
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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
MusicGlove Group

Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program

MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.

Control Group for Music Glove

Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.

Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers

Resonating Arm Exerciser (RAE)

Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program

Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

Control Group for RAE

Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.

Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises


Participant Flow:   Overall Study
    MusicGlove Group   Control Group for Music Glove   Resonating Arm Exerciser (RAE)   Control Group for RAE
STARTED   11   12   9   8 
COMPLETED   9   8   8   8 
NOT COMPLETED   2   4   1   0 
Lost to Follow-up                1                2                0                0 
unrelated injry                1                1                0                0 
got a job                0                1                0                0 
Got sick and could not complete study                0                0                1                0 



  Baseline Characteristics
  Hide 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.
There were 40 participants enrolled in the study, however 7 of them did not complete the study. We listed the 7 and their reasons of not completing study in section "participant flow overview".

Reporting Groups
  Description
MusicGlove Group

Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program

MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.

Control Group for Music Glove

Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.

Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers

Resonating Arm Exerciser (RAE)

Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program

Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.

Control Group for RAE

Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.

Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises

Total Total of all reporting groups

Baseline Measures
   MusicGlove Group   Control Group for Music Glove   Resonating Arm Exerciser (RAE)   Control Group for RAE   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   8   8   8   33 
Age 
[Units: Years]
Mean (Full Range)
 60 
 (45 to 74) 
 59 
 (35 to 74) 
 61 
 (32 to 80) 
 54 
 (39 to 76) 
 60 
 (32 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      4  44.4%      3  37.5%      2  25.0%      1  12.5%      10  30.3% 
Male      5  55.6%      5  62.5%      6  75.0%      7  87.5%      23  69.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      1  11.1%      1  12.5%      1  12.5%      1  12.5%      4  12.1% 
Not Hispanic or Latino      8  88.9%      7  87.5%      7  87.5%      7  87.5%      29  87.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      2  22.2%      2  25.0%      2  25.0%      2  25.0%      8  24.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  12.5%      0   0.0%      1  12.5%      2   6.1% 
White      6  66.7%      4  50.0%      5  62.5%      4  50.0%      19  57.6% 
More than one race      1  11.1%      1  12.5%      1  12.5%      1  12.5%      4  12.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   9   8   8   8   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Motor and Strength Outcome Measure Using Box and Block Test   [ Time Frame: From baseline to 1 month post therapy ]

2.  Primary:   Motor and Strength Outcome Measure Using Fugl-Meyer Score   [ Time Frame: From baseline to 1 month post therapy ]

3.  Other Pre-specified:   Range of Motion of Shoulder Joint   [ Time Frame: 1 month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: Steven Cramer, M.D.
Organization: University of California Irvine
phone: (949) 824-8748
e-mail: scramer@uci.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven C. Cramer, MD, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01769326     History of Changes
Other Study ID Numbers: HS# 2008-6432
R43HD074331-01 ( U.S. NIH Grant/Contract )
Study First Received: November 16, 2012
Results First Received: February 15, 2017
Last Updated: June 5, 2017