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
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
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.
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
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
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).
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
No
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
Email
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
No
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BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:
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