Status:
COMPLETED
Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Burke Medical Research Institute
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.
Detailed Description
Primary Hypothesis: The primary hypothesis is that robotic training compared with usual care and intensive comparison therapy will lead to improved upper extremity function. Eligible patients will be ...
Eligibility Criteria
Inclusion
- A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
- Age 18 years of age and older.
- Upper extremity Fugl-Meyer score \>=7 or \<=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
- Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
- Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
- Written informed consent to participate in the study.
Exclusion
- A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
- Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
- Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
- Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
- A complicating medical condition that would prevent completion of the trial.
- Unable to complete the nine-month study, e.g., extended planned vacation.
- Any other known pre-existing bone diseases that might increase the risk of bone fracture or other injury from intensive comparison therapy or robot-assisted therapy.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00372411
Start Date
December 1 2005
End Date
August 1 2009
Last Update
January 13 2014
Active Locations (5)
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1
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
2
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
3
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
4
Providence VA Medical Center
Providence, Rhode Island, United States, 02908-4799