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| Name | Class |
|---|---|
| Barrett Technology | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BURT | Device | Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Wolf Motor Function Test (WMFT) 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Tabb, PT | Contact | 6179526388 | dtabb1@mgb.org | |
| Federico Bauducco, MS | Contact | 6179526388 | fbauducco@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Recruiting | Charlestown | Massachusetts | 02129 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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
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| 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) |
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |