BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Device: Burt + BurtVision; Device: Burt

• Registration Number: NCT04940403
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02
• Study Start: 2023-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimanual robot-assisted upper-limb rehabilitation	Burt + BurtVision	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).
Unimanual robot-assisted upper-limb rehabilitation	Burt	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).

Primary Outcome Measures

Name	Time	Method
Motor Activity Log- Amount of Use	Data will be collected at baseline and at 7-8 weeks	Self-reported measures of upper extremity activity performance in daily life (amount of use)

Secondary Outcome Measures

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