BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

NCT04940403 | Not Yet Recruiting FDA Device

• 1 other identifier: 2021P001807
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Motor Activity Log- Amount of Use

  Self-reported measures of upper extremity activity performance in daily life (amount of use)

  Data will be collected at baseline and at 7-8 weeks

Secondary Outcomes (5)

• Fugl-Meyer Assessment, Upper-Extremity portion

  Data will be collected at baseline and at 7-8 weeks

• Wolf Motor Function Test

  Data will be collected at baseline and at 7-8 weeks

• Stroke Impact Scale

  Data will be collected at baseline and at 7-8 weeks

• Motor Activity Log- Quality of Use

  Data will be collected at baseline and at 7-8 weeks

• Upper-Extremity Accelerometry

  Data will be collected at baseline and at 7-8 weeks

Study Arms (2)

Unimanual robot-assisted upper-limb rehabilitation

ACTIVE COMPARATOR

Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will only train their hemiparetic arm (unimanual tasks only).

Device: Burt

Bimanual robot-assisted upper-limb rehabilitation

EXPERIMENTAL

Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will train their hemiparetic arm as well as interacting with the contralateral arm for bimanual tasks (unimanual + bimanual tasks).

Device: Burt + BurtVision

Interventions

Burt DEVICE

18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.

Unimanual robot-assisted upper-limb rehabilitation

Burt + BurtVision DEVICE

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

Bimanual robot-assisted upper-limb rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
• Individuals with open wounds or recent fracture (\<3 months) in the upper extremity, fragile skin or active infection;
• Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Bonato, PhD

  Harvard Medical School, Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Adans-Dester, PhD

CONTACT

617-952-6321; CADANS-DESTER@PARTNERS.ORG

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, HMS and Director, Motion Analysis Laboratory

Model Details: Study participants will be randomized to either 1) manual robot-assisted upper-limb rehabilitation, and 2) unimanual+bimanual robot-assisted upper-limb rehabilitation

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share