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Search / Trial NCT04940403

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Launched by SPAULDING REHABILITATION HOSPITAL · Jun 24, 2021

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new system called BurtVision™, which is designed to help people who have had a stroke improve the use of their arms. The Burt robotic arm assists patients in moving their upper limbs, while BurtVision uses fun augmented reality games to encourage patients to practice activities using one hand or both hands. The researchers want to see how well this system works for arm rehabilitation by comparing training that focuses on using just one hand versus training that includes both hands.

To participate in this study, you must be between 18 and 80 years old and have had a stroke at least six months but no more than five years ago. You should also have some movement ability in your affected hand and be able to understand instructions. People who are currently receiving upper-limb rehabilitation or have certain medical conditions, like severe muscle stiffness or communication difficulties, will not be eligible. If you join the trial, you will be using the BurtVision system during your rehabilitation sessions, which could make your therapy more engaging and enjoyable!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Male or female, 18-80 years old;
  • 2. Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
  • 3. Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
  • 4. Some active pro-supination range of motion;
  • 5. Some active metacarpal-phalangeal joint in the hemiparetic hand;
  • 6. Intact cognitive function to understand the robotic therapy procedures (MMSE\>23 and able to follow 3 step command) during initial evaluation visit;
  • Exclusion Criteria:
  • 1. Undergoing upper-limb rehabilitation therapy during the period of the study.
  • 2. Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
  • 3. Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
  • 4. Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
  • 5. Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
  • 6. Individuals with open wounds or recent fracture (\<3 months) in the upper extremity, fragile skin or active infection;
  • 7. Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.

About Spaulding Rehabilitation Hospital

Spaulding Rehabilitation Hospital is a leading academic medical center dedicated to advancing the field of rehabilitation medicine. Affiliated with Harvard Medical School, Spaulding is renowned for its commitment to patient-centered care, innovative research, and comprehensive rehabilitation services. The hospital actively conducts clinical trials to explore novel therapies and improve outcomes for individuals with disabilities and chronic conditions. Through collaboration with multidisciplinary teams and a focus on evidence-based practices, Spaulding Rehabilitation Hospital aims to enhance the quality of life for its patients while contributing to the advancement of rehabilitation science.

Locations

Patients applied

0 patients applied

Trial Officials

Paolo Bonato, PhD

Principal Investigator

Harvard Medical School, Spaulding Rehabilitation Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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