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BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Primary Purpose

Stroke

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Burt

Burt + BurtVision

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Unimanual robot-assisted upper-limb rehabilitation

Bimanual robot-assisted upper-limb rehabilitation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Motor Activity Log- Amount of Use

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

Secondary Outcome Measures

Fugl-Meyer Assessment, Upper-Extremity portion

Assessment of the severity of upper-limb motor impairments

Wolf Motor Function Test

Assessment of arm functional limitations

Stroke Impact Scale

Self-reported measure of quality of life after stroke

Motor Activity Log- Quality of Use

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

Upper-Extremity Accelerometry

Amount of arm use over 72 hours recording with wrist-worn sensors

Full Information

NCT ID

NCT04940403

First Posted

June 17, 2021

Last Updated

August 31, 2022

Sponsor

Spaulding Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04940403

Brief Title

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Official Title

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

Outcome assessor will be blinded to the treatment allocation.

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Unimanual robot-assisted upper-limb rehabilitation

Arm Type

Active Comparator

Arm Description

Arm Title

Bimanual robot-assisted upper-limb rehabilitation

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Burt

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Burt + BurtVision

Intervention Description

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

Primary Outcome Measure Information:

Title

Motor Activity Log- Amount of Use

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Fugl-Meyer Assessment, Upper-Extremity portion

Description

Assessment of the severity of upper-limb motor impairments

Time Frame

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

Title

Wolf Motor Function Test

Description

Assessment of arm functional limitations

Time Frame

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

Title

Stroke Impact Scale

Description

Self-reported measure of quality of life after stroke

Time Frame

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

Title

Motor Activity Log- Quality of Use

Description

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

Time Frame

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

Title

Upper-Extremity Accelerometry

Description

Amount of arm use over 72 hours recording with wrist-worn sensors

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Adans-Dester, PhD

Phone

617-952-6321

CADANS-DESTER@PARTNERS.ORG

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paolo Bonato, PhD

Organizational Affiliation

Harvard Medical School, Spaulding Rehabilitation Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

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