Status:
COMPLETED
Evaluation of Robot Assisted Neuro-Rehabilitation
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Massachusetts Institute of Technology
University of Maryland, College Park
Conditions:
Stroke
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm f...
Detailed Description
After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinema...
Eligibility Criteria
Inclusion
- Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses
- Adequate language, and cognitive function to participate in training, testing, and informed consent process
- The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38
- Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke
- Men or women over 21 years of age
Exclusion
- Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
- Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
- Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions
- Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer
- Botox injection to the study arm within 3 months of enrollment or during the study period
- Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
Key Trial Info
Start Date :
April 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2015
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01253018
Start Date
April 27 2011
End Date
January 30 2015
Last Update
October 30 2019
Active Locations (1)
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1
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201