Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 82
- Locations
- 4
- Primary Endpoint
- 9 Hole Peg Test (9HPT)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 115 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inpatient at Sunnyview Rehabilitation Hospital
- •>/= 18 years
- •Unilateral stroke
- •UE paresis affected arm with 3-/5 or less manual muscle testing throughout
Exclusion Criteria
- •>30 days post stroke
- •Severe Neglect
- •Bilateral stroke
- •Prior stroke with residual deficits
- •Patients receiving prism adaptation treatment
- •Comorbid neurological disorders
- •Upper limb comorbidities that could limit functional improvement (UE arthritis pain, UE fracture, fixed contracture not allowing for proper device alignment)
- •Severe shoulder subluxation that cannot be accommodated by the device
- •Severe osteoporosis
- •Unable to follow simple directions
- •Unable to tolerate sitting 30 minutes
- •Expected length of stay (LOS) < 15 days.
Arms & Interventions
Conventional Upper Extremity Neuroeducation
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
Intervention: Other Occupational Therapy (Procedure)
BURT Upper Extremity
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.
Intervention: BURT (Device)
BURT Upper Extremity
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.
Intervention: Other Occupational Therapy (Procedure)
Outcomes
Primary Outcomes
9 Hole Peg Test (9HPT)
Time Frame: T1 (Day 12-14) - T0 (Day 4-6)
The 9HPT is a standardized test that measures manual dexterity.
UE Motor Assessment Scale (UE-MAS)
Time Frame: T1 (Day 12-14) - T0 (Day 4-6)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Modified Ashworth Scale (MAS)
Time Frame: T1 (Day 12-14) - T0 (Day 4-6)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Manual Muscle Testing (MMT)
Time Frame: T1 (Day 12-14) - T0 (Day 4-6)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Secondary Outcomes
- GG Scores for Mobility items(Change from admission to discharge, up to 55 days)
- GG Scores for Self-Care Items(Change from admission to discharge, up to 55 days)
Investigators
Casey Cowan
Occupational Therapist
Sunnyview Rehabilitation Hospital