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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Burt; Device: Burt + BurtVision

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.

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Adans-Dester, PhD; Phone Number: 617-952-6321; Email: CADANS-DESTER@PARTNERS.ORG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Device: Burt; 18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
Experimental: 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).	Device: Burt + BurtVision; 18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment, Upper-Extremity portion	Assessment of the severity of upper-limb motor impairments	Data will be collected at baseline and at 7-8 weeks
Wolf Motor Function Test	Assessment of arm functional limitations	Data will be collected at baseline and at 7-8 weeks
Stroke Impact Scale	Self-reported measure of quality of life after stroke	Data will be collected at baseline and at 7-8 weeks
Motor Activity Log- Quality of Use	Self-reported measures of upper extremity activity performance in daily life (quality of use)	Data will be collected at baseline and at 7-8 weeks
Upper-Extremity Accelerometry	Amount of arm use over 72 hours recording with wrist-worn sensors	Data will be collected at baseline and at 7-8 weeks

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Paolo Bonato, PhD, Harvard Medical School, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021P001807

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes