BURT
Device18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
NCT Number: NCT04940403
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Data will be collected at baseline and at 7-8 weeks
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
Assessment of the severity of upper-limb motor impairments
Time frame: Data will be collected at baseline and at 7-8 weeks
Assessment of arm functional limitations
Time frame: Data will be collected at baseline and at 7-8 weeks
Self-reported measure of quality of life after stroke
Time frame: Data will be collected at baseline and at 7-8 weeks
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
Amount of arm use over 72 hours recording with wrist-worn sensors
Contact information is provided by the study sponsor or research team.
Spaulding Rehabilitation Hospital
Other
BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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