BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

NCT ID: NCT04940403

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-06-01

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.

Detailed Description

The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unimanual robot-assisted upper-limb rehabilitation

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).

Group Type: ACTIVE_COMPARATOR

Burt

Intervention Type: DEVICE

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

Bimanual robot-assisted upper-limb rehabilitation

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).

Group Type: EXPERIMENTAL

Burt + BurtVision

Intervention Type: DEVICE

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

Interventions

Burt

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

Intervention Type: DEVICE

Burt + BurtVision

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

Associate Professor, HMS and Director, Motion Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School, Spaulding Rehabilitation Hospital

Central Contacts

Catherine Adans-Dester, PhD

Role: CONTACT

CADANS-DESTER@PARTNERS.ORG

617-952-6321

Other Identifiers

2021P001807

Identifier Type: -

Identifier Source: org_study_id