- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331407
Effect of Robot Rehabilitation Exercise Training on Motor Control After Stroke
April 18, 2019 updated by: Columbia University
Stroke is a leading cause of neurological disability worldwide, often causing significant weakening and paresis of the affected arm.
National spending on post-stroke rehabilitation is project to expand 20% to 35% through 2010.
As a new tool for therapists, robotic stroke therapy devices have the potential to be a cost-effective device aid to physical therapy and enable novel modes of exercise not currently available.
While recent studies have shown chronic patients benefit from repetitive practice, it is not clear whether they improved via a reduction in impairment or increased functional compensation because there is a lack of standard treatment and scales to assess rehabilitation efficacy in chronic stroke patients.
This study aims to reconcile difference performance measurements in robotic rehabilitation to assess the outcome of robotic rehabilitation training.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia Univeristy, Neurological Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hemiparesis of the upper extremity
- Diagnosis of a first clinically apparent ischemic stroke at least 6 months prior to study entry
- Age 18 years or older
- Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory disturbances and/or pain.
Exclusion Criteria:
- Inability to understand and/or follow instructions
- Pain in shoulder or arm
- Other neurological or musculoskeletal target organ disorder
- Inability to give informed consent personally
- Previous or current contracture of the upper extremity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robot arm rehabilitation therapy
Arm training using the ReoGo robotic device, 3 times a week for 3 weeks.
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Training with the ReoGo device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance
Time Frame: From baseline to within 1 week post-therapy
|
Arm motor control was assessed through analysis of reaching movements to targets.
We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance).
This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.
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From baseline to within 1 week post-therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer (FM) Upper Extremity Motor Assessment
Time Frame: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
|
The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination.
Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66.
A higher score indicates a better outcome.
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baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
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Action Research Arm Test
Time Frame: baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
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The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement.
Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class.
Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57.
A higher score indicates a better outcome.
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baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Krakauer, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
January 1, 2015
First Submitted That Met QC Criteria
January 2, 2015
First Posted (Estimate)
January 6, 2015
Study Record Updates
Last Update Posted (Actual)
May 7, 2019
Last Update Submitted That Met QC Criteria
April 18, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAD3437
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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