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NCT04940403Not yet recruiting

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
38 (estimated)
First submitted
17 Jun 2021
Start date
Sept 2026
Primary completion date
Feb 2027
Lead sponsor
Spaulding Rehabilitation Hospital
Diseases
Stroke
NCT number
NCT04940403

What you commit to

  • Study type: Interventional
  • Planned participants: 38
  • From Sept 2026 to the primary completion date, Feb 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Undergoing upper-limb rehabilitation therapy during the period of the study.

Other illness

  • 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);
  • Individuals with open wounds or recent fracture (\<3 months) in the upper extremity, fragile skin or active infection;

Other

  • Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
  • Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
  • Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
  • Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.

Who the study is looking for

  • Male or female, 18-80 years old;
  • Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
  • Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
  • Some active pro-supination range of motion;
  • Some active metacarpal-phalangeal joint in the hemiparetic hand;
  • Intact cognitive function to understand the robotic therapy procedures (MMSE\>23 and able to follow 3 step command) during initial evaluation visit;

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.