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RecruitingNCT04851886Updated Apr 2, 2026

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

An interventional study of BURT and BURT + PostureCheck in Stroke, sponsored by Spaulding Rehabilitation Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's planned enrollment of 42 is below the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    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).

    Device: BURT

  • Experimental
    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.

    Device: BURT + PostureCheck

Interventions

  • DeviceBURT

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

  • DeviceBURT + 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)

06

What researchers measure

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

    Time frame: Data will be collected at baseline and at 7-8 weeks

Secondary outcomes

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

    Standard assessment of functional limitations

    Time frame: Data will be collected at baseline and at 7-8 weeks

  2. 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

    Time frame: Data will be collected at baseline and at 7-8 weeks

07

Study locations

1 of 1 sites recruiting
  • Spaulding Rehabilitation Hospital
    Charlestown, Massachusetts 02129, United States
    • Daniel Tabb, PT · Contact · dtabb1@mgb.org · 617-952-6388
    • Federico Bauducco, MS · Contact · fbauducco@mgb.org · 617-952-6388
    • Paolo Bonato, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04851886
Lead sponsor
Spaulding Rehabilitation Hospital
Collaborators
Barrett Technology
Responsible party
Paolo Bonato (Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital) — Principal investigator
First posted
Apr 21, 2021
Start date
Apr 26, 2024
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 2, 2026

Study contacts

Daniel Tabb, PT
Contact
dtabb1@mgb.org
6179526388
Federico Bauducco, MS
Contact
fbauducco@mgb.org
6179526388
Paolo Bonato, PhD
principal investigator · Harvard Medical School (HMS and HSDM)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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