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

NCT ID: NCT04851886

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individual robot-assisted upper-limb rehabilitation

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).

Group Type: ACTIVE_COMPARATOR

BURT

Intervention Type: DEVICE

Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology

Group robot-assisted upper-limb rehabilitation

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.

Group Type: EXPERIMENTAL

BURT + PostureCheck

Intervention Type: DEVICE

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)

Interventions

BURT

Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology

Intervention Type: DEVICE

BURT + PostureCheck

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barrett Technology

UNKNOWN

Sponsor Role: collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

Director, Motion Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Central Contacts

Catherine Adans-Dester, PhD

Role: CONTACT

cadans-dester@partners.org

6179526321

Gregory Schiurring, BS

Role: CONTACT

gschiurring@partners.org

6179526331

Other Identifiers

2021P000197

Identifier Type: -

Identifier Source: org_study_id