- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00011583
Robot Assisted Upper Limb Neuro-Rehabilitation
Our long term objectives are to understand the mechanisms of motor impairment following neurologic injury and to develop interventions to improve motor recovery. A series of complementary, overlapping clinical trials and development activities will validate and optimize the use of robot-assisted upper limb therapy for neuro rehabilitation.
We have developed a robotic system that assists or resists elbow and shoulder movements in three dimensional space. In addition to unilateral exercise modes, a novel bimanual mode enables hemiparetic subjects to practice mirror image upper limb exercises.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Temple, Texas, United States, 76504
- Central Texas Veterans Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Stroke patients
Exclusion Criteria:
Unable to follow instructions; medically unstable.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
1 hour/day of mechanically-assisted upper limb therapy
|
1 hour/day of mechanically-assisted upper limb therapy
|
Active Comparator: 2
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
|
1 hour/day of upper limb therapy that includes exposure to, but no manipulation by the robot
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fugl-Meyer score
Time Frame: end of training, 6-month follow-up
|
end of training, 6-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Charles Burgar, MD, Central Texas Veterans Health Care System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2156
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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