- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04851886
PostureCheck: A Vision-based Compensatory-posture-detection Tool for Robot-assisted Upper-limb Therapy
May 10, 2023 updated by: Paolo Bonato, Spaulding Rehabilitation Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gregory Schiurring, BS
- Phone Number: 6179526331
- Email: gschiurring@partners.org
Study Contact Backup
- Name: Catherine Adans-Dester, PhD
- Phone Number: 6179526321
- Email: cadans-dester@partners.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
Robot-assisted upper-limb individual (i.e.
one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology
|
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.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Data will be collected at baseline and at 7-8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Standard assessment of functional limitations
|
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
|
Self-report of amount and quality of use of the stroke-affected upper limb
|
Data will be collected at baseline and at 7-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paolo Bonato, PhD, Harvard Medical School (HMS and HSDM)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2023
Primary Completion (Anticipated)
September 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
April 14, 2021
First Submitted That Met QC Criteria
April 19, 2021
First Posted (Actual)
April 21, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2023
Last Update Submitted That Met QC Criteria
May 10, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021P000197
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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