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

NCT04851886 | Recruiting FDA Device

• 1 other identifier: 2021P000197
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks

  Standard assessment of the severity of upper-limb motor impairments

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

Secondary Outcomes (2)

• Change from baseline Wolf Motor Function Test (WMFT) at 7-8 weeks

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

• Change from baseline Motor Activity Log (MAL) at 7-8 weeks

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

Study Arms (2)

Individual robot-assisted upper-limb rehabilitation

ACTIVE COMPARATOR

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).

Device: BURT

Group robot-assisted upper-limb rehabilitation

EXPERIMENTAL

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.

Device: BURT + PostureCheck

Interventions

BURT DEVICE

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

Individual robot-assisted upper-limb rehabilitation

BURT + PostureCheck 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)

Group robot-assisted upper-limb rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Barrett Technology: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Bonato, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Tabb, PT

CONTACT

6179526388; dtabb1@mgb.org

Federico Bauducco, MS

CONTACT

6179526388; fbauducco@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Model Details: 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

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 21, 2021
• Study Start: April 26, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)