An interventional study of BURT and Other Occupational Therapy in Stroke, Stroke, Acute and Cerebral Vascular Accident, sponsored by Sunnyview Rehabilitation Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years to 115 Years. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Sunnyview Rehabilitation Hospital · Not applicable, Interventional, and Treatment
The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Activities are directed by therapists and encourage patient involvement through video game activities providing active proprioceptive, vibrational, visual and auditory feedback. Engaging and colorful games are beneficial in holding patients' interest, and gravity assistance may also allow for increased repetition in the face of patient fatigue.
In this prospective study, the investigators will determine if a standardized BURT Upper Extremity (UE) program can be consistently implemented within an acute inpatient rehabilitation facility (IRF). In addition, the investigators will see if patients who receive BURT have improved UE mobility and function as a result. The investigators will also study the perceived enjoyment and value of the intervention by patients, and perceived value by therapists.
Because BURT therapy is able to provide more repetitions of upper extremity movement in a shorter length of time than conventional therapy, the investigators hypothesize that patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor coordination, activities of daily living and mobility during their time in an IRF than patients receiving conventional therapy.
In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or BURT therapy. Meaningful clinical benchmarks for upper extremity function, tone, fine motor coordination, activities of daily living and mobility will be assessed using the Upper Extremity Motor Assessment Scale (UE-MAS)(Zelter, 2010), manual muscle testing (MMT), Modified Ashworth Scale (MAS) (Figueiredo, 2011) and the 9-hole peg test (9HPT)(Figueiredo, 2011). The investigators also hypothesize that patients in the BURT cohort will report greater value/usefulness and interest/enjoyment.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 82 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Sunnyview Rehabilitation Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
>30 days post stroke
74 patients will receive the standard occupational therapy sessions that they would normally receive during their IRF stay. UE neuroeducation sessions are typically focused on improving strength and mobility of the upper arm. Clinicians will not be given instructions on how to run their sessions, however they will not be allowed to use BURT. Other devices that would normally be used during neuro-educational sessions (including X-cite, electrical stimulation and RT-300) will be allowed for use in this group. The therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur
Procedure: Other Occupational Therapy
As part of routine therapy, 74 patients will receive up to 5 sessions per week of BURT UE therapy in place of conventional neuro re-education. Patients in this arm of the study will receive any conventional therapy during the remainder of their treatment sessions. When using BURT, therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur.
Device: BURT · Procedure: Other Occupational Therapy
Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.
Standard occupational therapy sessions will be 60-90 minutes a day and are UE neuroeducation sessions are typically focused on improving strength and mobility of the hemipelagic arm.
UE Motor Assessment Scale (UE-MAS)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Time frame: T2(Day 20-23) - T0 (Day 4-6)
UE Motor Assessment Scale (UE-MAS)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
Manual Muscle Testing (MMT)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Time frame: T2(Day 20-23) - T0 (Day 4-6)
Manual Muscle Testing (MMT)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
Modified Ashworth Scale (MAS)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Time frame: T2(Day 20-23) - T0 (Day 4-6)
Modified Ashworth Scale (MAS)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
9 Hole Peg Test (9HPT)
The 9HPT is a standardized test that measures manual dexterity.
Time frame: T2(Day 20-23) - T0 (Day 4-6)
9 Hole Peg Test (9HPT)
The 9HPT is a standardized test that measures manual dexterity.
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
GG Scores for Self-Care Items
standardized assessments of functional independence for feeding, bathing, toileting, footwear, upper and lower body dressing and oral hygiene.
Time frame: Change from admission to discharge, up to 55 days
GG Scores for Mobility items
standardized assessments of functional independence for bed mobility and transfers.
Time frame: Change from admission to discharge, up to 55 days
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Sunnyview Rehabilitation Hospital