Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.
The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after 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: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unimanual robot-assisted upper-limb rehabilitation | Active Comparator | Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will only train their hemiparetic arm (unimanual tasks only). |
|
| Bimanual robot-assisted upper-limb rehabilitation | Experimental | Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will train their hemiparetic arm as well as interacting with the contralateral arm for bimanual tasks (unimanual + bimanual tasks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Burt | Device | 18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor Activity Log- Amount of Use | Self-reported measures of upper extremity activity performance in daily life (amount of use) | Data will be collected at baseline and at 7-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment, Upper-Extremity portion | Assessment of the severity of upper-limb motor impairments | Data will be collected at baseline and at 7-8 weeks |
| Wolf Motor Function Test | Assessment of arm functional limitations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Adans-Dester, PhD | Contact | 617-952-6321 | CADANS-DESTER@PARTNERS.ORG |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Harvard Medical School, Spaulding Rehabilitation Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Study participants will be randomized to either 1) manual robot-assisted upper-limb rehabilitation, and 2) unimanual+bimanual robot-assisted upper-limb rehabilitation
Not provided
Not provided
Outcome assessor will be blinded to the treatment allocation.
| Burt + BurtVision | Device | 18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision. |
|
| Data will be collected at baseline and at 7-8 weeks |
| Stroke Impact Scale | Self-reported measure of quality of life after stroke | Data will be collected at baseline and at 7-8 weeks |
| Motor Activity Log- Quality of Use | Self-reported measures of upper extremity activity performance in daily life (quality of use) | Data will be collected at baseline and at 7-8 weeks |
| Upper-Extremity Accelerometry | Amount of arm use over 72 hours recording with wrist-worn sensors | Data will be collected at baseline and at 7-8 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |