An interventional study of Burt and Burt + BurtVision in Stroke, sponsored by Spaulding Rehabilitation Hospital. Not yet recruiting. 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
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 38 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →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.
Exclusion Criteria:
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).
Device: Burt
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).
Device: Burt + BurtVision
18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.
Motor Activity Log- Amount of Use
Self-reported measures of upper extremity activity performance in daily life (amount of use)
Time frame: Data will be collected at baseline and at 7-8 weeks
Fugl-Meyer Assessment, Upper-Extremity portion
Assessment of the severity of upper-limb motor impairments
Time frame: Data will be collected at baseline and at 7-8 weeks
Wolf Motor Function Test
Assessment of arm functional limitations
Time frame: Data will be collected at baseline and at 7-8 weeks
Stroke Impact Scale
Self-reported measure of quality of life after stroke
Time frame: 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)
Time frame: 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
Time frame: Data will be collected at baseline and at 7-8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital