BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

ConditionStroke

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorSpaulding Rehabilitation Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;

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);

Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;

Trial design

Design model

Parallel

Treatments tested in this trial

Burt
Device
18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
Burt + BurtVision
Device
18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.

Treatment groups

38 Participants

are divided into 2 treatment groups

Group A: Unimanual robot-assisted upper-limb rehabilitationActive comparator 1 intervention

Group B: Bimanual robot-assisted upper-limb rehabilitationExperimental treatment 1 intervention

Trial outcomes