StrokeNCT04851886
PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy
A study testing BURT and BURT + PostureCheck in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- BURT and BURT + PostureCheck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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))
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
Daniel Tabb, PT, 617-952-6388, dtabb1@mgb.org
Federico Bauducco, MS, 617-952-6388, fbauducco@mgb.org
About this study
Official title: PostureCheck: A Vision-based Compensatory-posture-detection Tool to Enhance Performance of the BURT Upper-extremity Stroke-therapy
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.
- Conditions
- Stroke
- Being tested
- BURT, BURT + PostureCheck
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BURTDevice
Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology
BURT + PostureCheckDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: BURT + PostureCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
Standard assessment of the severity of upper-limb motor impairments
Measured: 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
Standard assessment of functional limitations
Measured: Data will be collected at baseline and at 7-8 weeks
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
Measured: Data will be collected at baseline and at 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start26 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Barrett Technology
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851886
- Sponsor's protocol ID
- 2021P000197
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PostureCheck: A Vision-based Compensatory-posture-detection Tool to Enhance Performance of the BURT Upper-extremity Stroke-therapy
- ClinicalTrials.gov ID
- NCT04851886
- Acronym / sponsor ID
- 2021P000197
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Barrett Technology
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Individual robot-assisted upper-limb rehabilitation | Active comparator | Device: BURTParticipants 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 robot-assisted upper-limb rehabilitation | Experimental | Device: BURT + PostureCheckParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BURTRobot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology | Device | Individual robot-assisted upper-limb rehabilitation |
| BURT + PostureCheckRobot-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) | Device | Group robot-assisted upper-limb rehabilitation |
Primary outcome
Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks
Time frame: Data will be collected at baseline and at 7-8 weeks
Standard assessment of the severity of upper-limb motor impairments
2 secondary outcomes
Change from baseline Wolf Motor Function Test (WMFT) at 7-8 weeks
Time frame: Data will be collected at baseline and at 7-8 weeks
Change from baseline Motor Activity Log (MAL) at 7-8 weeks
Time frame: Data will be collected at baseline and at 7-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paolo Bonato, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BURT and BURT + PostureCheck in people with Stroke, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Tabb, PT (6179526388, dtabb1@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE) at 7-8 weeks (time frame: Data will be collected at baseline and at 7-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.