Back to resultsInnovative Modalities for Restoring Upper Limb Function Post Stroke
Primary Purpose
Cerebrovascular Accident
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motor Learning
Robotics
surface FES
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Stroke, electric stimulation, robotics, motor learning
Eligibility Criteria
Inclusion Criteria:
- >1 year post stroke no acute, uncontrolled medical condition single stroke
Exclusion Criteria:
- pacemaker other neurological condition more than one stroke
Sites / Locations
- Louis Stokes Cleveland Department of Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Motor Learning
Robotics and Motor Learning
Motor learning and FES
Arm Description
subjects are provided with intensive motor learning training of the upper limb
subject are provided with intensive motor learning and robotics training of the upper limb
subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb
Outcomes
Primary Outcome Measures
Fugl Meyer
impairment measure of coordination of the upper limb
Secondary Outcome Measures
Full Information
NCT ID
NCT01725659
First Posted
November 9, 2012
Last Updated
November 9, 2012
Sponsor
Malcom Randall VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01725659
Brief Title
Innovative Modalities for Restoring Upper Limb Function Post Stroke
Official Title
Innovative Modalities for Restoring Upper Limb Function Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Malcom Randall VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Stroke, electric stimulation, robotics, motor learning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motor Learning
Arm Type
Experimental
Arm Description
subjects are provided with intensive motor learning training of the upper limb
Arm Title
Robotics and Motor Learning
Arm Type
Experimental
Arm Description
subject are provided with intensive motor learning and robotics training of the upper limb
Arm Title
Motor learning and FES
Arm Type
Experimental
Arm Description
subjects are provided with intensive motor learning and surface FES (Functional Electrical Stimulation) of the upper limb
Intervention Type
Other
Intervention Name(s)
Motor Learning
Intervention Description
training of the hemiplegic upper limb with motor learning
Intervention Type
Other
Intervention Name(s)
Robotics
Intervention Description
subjects perform training of hemiplegic arm using an upper extremity robot
Intervention Type
Other
Intervention Name(s)
surface FES
Intervention Description
subjects are provided with surface FES to the hemiplegic upper limb
Primary Outcome Measure Information:
Title
Fugl Meyer
Description
impairment measure of coordination of the upper limb
Time Frame
after 12 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>1 year post stroke no acute, uncontrolled medical condition single stroke
Exclusion Criteria:
pacemaker other neurological condition more than one stroke
Facility Information:
Facility Name
Louis Stokes Cleveland Department of Veterans Affairs Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
12. IPD Sharing Statement
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Innovative Modalities for Restoring Upper Limb Function Post Stroke
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