Trial Search Results

Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients

This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

US Department of Veterans Affairs

Collaborator: Burke Medical Research Institute

Stanford Investigator(s):

Intervention(s):

  • Device: Robot-Assisted Therapy - MIT-MANUS System
  • Other: Intensive Comparison Therapy
  • Other: Usual Care

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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 Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting