search
Back to results

PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BURT
BURT + PostureCheck
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Have had a history of ischemic cerebrovascular accident (CVA) within middle cerebral artery (MCA) or anterior cerebral artery (ACA) territory
  • CVA occurred between six months and six years ago
  • Moderate to severe UE impairment, FMA-UE score between 15 and 45
  • Mini-Mental State Examination (MMSE) score >23 and being able to safely follow three-step commands

Exclusion Criteria:

  • Advanced musculoskeletal pathology or recent fractures in the impaired UE
  • Previous diagnosis of neurological diseases other than stroke
  • Severe limitation of passive range of motion or spasticity (Modified Ashworth Scale for spasticity at <3 for UE muscles)
  • Hemorrhagic CVA or involvement of the posterior cerebral artery
  • Aphasia sufficient to limit ability to express needs or discomfort verbally or non-verbally
  • Impaired visual acuity (Severe visual impairments as assessed by the NIH Stroke Scale Visual Field subscale. (score >0))
  • Severe hemispatial neglect as assessed by the Line Bisection Test (score >2)
  • Severely impaired trunk control (<4)
  • Individuals who present with the following on the intended limb:
  • Open wounds
  • Fragile skin
  • Under contact precautions due to an active infection
  • Participation in another therapy focused on recovery of the impaired arm
  • Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices, that are not US-certified
  • Any Condition that would prevent safe use of the Burt system; such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination
  • Current pregnancy (self-report)
  • The concern is strictly towards women who are in the 2nd or 3rd trimester and the eventuality of the arm of the BURT accidentally impacting the woman's belly. The system does have safety features (including a virtual safety wall, to keep the device away from the patient's body) but we are taking this as an extra precaution against any potential harm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Individual robot-assisted upper-limb rehabilitation

    Group robot-assisted upper-limb rehabilitation

    Arm Description

    Participants randomized to this arm of the study will undergo 18 sessions of robot-assisted upper-limb rehabilitation. During the sessions, a therapist will administer one-on-one therapy (i.e. each study volunteer will work with a single therapist).

    Participants randomized to this arm of the study will also undergo 18 sessions of robot-assisted upper-limb rehabilitation. However, a therapist will administer the intervention as group therapy with up to three subjects participating in the session at the same time. To facilitate the deliver of the therapeutic intervention, the robot will be equipped with a camera system (called PostureCheck) designed to track the quality of the exercises.

    Outcomes

    Primary Outcome Measures

    Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
    Standard assessment of the severity of upper-limb motor impairments

    Secondary Outcome Measures

    Change from baseline Wolf Motor Function Test (WMFT) at 7-8 weeks
    Standard assessment of functional limitations
    Change from baseline Motor Activity Log (MAL) at 7-8 weeks
    Self-report of amount and quality of use of the stroke-affected upper limb

    Full Information

    First Posted
    April 14, 2021
    Last Updated
    May 10, 2023
    Sponsor
    Spaulding Rehabilitation Hospital
    Collaborators
    Barrett Technology
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04851886
    Brief Title
    PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy
    Official Title
    PostureCheck: A Vision-based Compensatory-posture-detection Tool to Enhance Performance of the BURT Upper-extremity Stroke-therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spaulding Rehabilitation Hospital
    Collaborators
    Barrett Technology

    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 overall objective of this study is to assess whether robot-assisted upper-limb group rehabilitation can be effectively delivered by using a camera-based system equipped with machine learning algorithms to track the quality of the exercise performance and provide feedback accordingly. To address this question, we plan to carry out a randomized clinical trial to compare outcomes in subjects receiving robot-assisted upper-limb rehabilitation during individual (i.e., one-on-one) sessions and in subjects receiving robot-assisted upper-limb rehabilitation during group (i.e., up to three subjects) sessions.
    Detailed Description
    The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the PostureCheck (a camera-based system equipped with machine learning algorithms to track the quality of the exercise performance) on motor gains in group and individual 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: individual- or group-therapy using a covariate-adaptive allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and proprioceptive deficits, 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) one-on-one robot-assisted upper-limb rehabilitation, and 2) group (up to three subjects per session) robot-assisted upper-limb rehabilitation
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individual robot-assisted upper-limb rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    Participants randomized to this arm of the study will undergo 18 sessions of robot-assisted upper-limb rehabilitation. During the sessions, a therapist will administer one-on-one therapy (i.e. each study volunteer will work with a single therapist).
    Arm Title
    Group robot-assisted upper-limb rehabilitation
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm of the study will also undergo 18 sessions of robot-assisted upper-limb rehabilitation. However, a therapist will administer the intervention as group therapy with up to three subjects participating in the session at the same time. To facilitate the deliver of the therapeutic intervention, the robot will be equipped with a camera system (called PostureCheck) designed to track the quality of the exercises.
    Intervention Type
    Device
    Intervention Name(s)
    BURT
    Intervention Description
    Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology
    Intervention Type
    Device
    Intervention Name(s)
    BURT + PostureCheck
    Intervention Description
    Robot-assisted upper-limb group (i.e. up to three subjects) rehabilitation will be delivered using the BURT system by Barrett Technology + PostureChek (a camera-based system to track the quality of the exercises)
    Primary Outcome Measure Information:
    Title
    Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
    Description
    Standard assessment of the severity of upper-limb motor impairments
    Time Frame
    Data will be collected at baseline and at 7-8 weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline Wolf Motor Function Test (WMFT) at 7-8 weeks
    Description
    Standard assessment of functional limitations
    Time Frame
    Data will be collected at baseline and at 7-8 weeks
    Title
    Change from baseline Motor Activity Log (MAL) at 7-8 weeks
    Description
    Self-report of amount and quality of use of the stroke-affected upper limb
    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: Have had a history of ischemic cerebrovascular accident (CVA) within middle cerebral artery (MCA) or anterior cerebral artery (ACA) territory CVA occurred between six months and six years ago Moderate to severe UE impairment, FMA-UE score between 15 and 45 Mini-Mental State Examination (MMSE) score >23 and being able to safely follow three-step commands Exclusion Criteria: Advanced musculoskeletal pathology or recent fractures in the impaired UE Previous diagnosis of neurological diseases other than stroke Severe limitation of passive range of motion or spasticity (Modified Ashworth Scale for spasticity at <3 for UE muscles) Hemorrhagic CVA or involvement of the posterior cerebral artery Aphasia sufficient to limit ability to express needs or discomfort verbally or non-verbally Impaired visual acuity (Severe visual impairments as assessed by the NIH Stroke Scale Visual Field subscale. (score >0)) Severe hemispatial neglect as assessed by the Line Bisection Test (score >2) Severely impaired trunk control (<4) Individuals who present with the following on the intended limb: Open wounds Fragile skin Under contact precautions due to an active infection Participation in another therapy focused on recovery of the impaired arm Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices, that are not US-certified Any Condition that would prevent safe use of the Burt system; such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination Current pregnancy (self-report) The concern is strictly towards women who are in the 2nd or 3rd trimester and the eventuality of the arm of the BURT accidentally impacting the woman's belly. The system does have safety features (including a virtual safety wall, to keep the device away from the patient's body) but we are taking this as an extra precaution against any potential harm
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Catherine Adans-Dester, PhD
    Phone
    6179526321
    Email
    cadans-dester@partners.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gregory Schiurring, BS
    Phone
    6179526331
    Email
    gschiurring@partners.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paolo Bonato, PhD
    Organizational Affiliation
    Harvard Medical School (HMS and HSDM)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy

    We'll reach out to this number within 24 hrs