BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Sponsor
Spaulding Rehabilitation Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04940403
Collaborator
(none)
38
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Burt
  • Device: Burt + BurtVision
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Study participants will be randomized to either 1) manual robot-assisted upper-limb rehabilitation, and 2) unimanual+bimanual robot-assisted upper-limb rehabilitationStudy participants will be randomized to either 1) manual robot-assisted upper-limb rehabilitation, and 2) unimanual+bimanual robot-assisted upper-limb rehabilitation
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessor will be blinded to the treatment allocation.
Primary Purpose:
Treatment
Official Title:
BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Wolf Motor Function Test [Data will be collected at baseline and at 7-8 weeks]

    Assessment of arm functional limitations

  3. Stroke Impact Scale [Data will be collected at baseline and at 7-8 weeks]

    Self-reported measure of quality of life after stroke

  4. 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)

  5. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Spaulding Rehabilitation Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Bonato, Associate Professor, HMS and Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT04940403
Other Study ID Numbers:
  • 2021P001807
First Posted:
Jun 25, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021