Clinical trial NCT05401799: BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation
Official title: Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Acute
Cerebral Vascular Accident
Cerebral Vascular Accident (CVA)/Stroke
Keywords: BURT
Upper extremity function
Inpatient rehabilitation
Upper extremity robotics
Lead sponsor: Sunnyview Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Gaylord Hospital
First posted: 2022-06-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: UE Motor Assessment Scale (UE-MAS)
timeFrame: T2(Day 20-23) - T0 (Day 4-6)
measure: UE Motor Assessment Scale (UE-MAS)
timeFrame: T1 (Day 12-14) - T0 (Day 4-6)
measure: Manual Muscle Testing (MMT)
timeFrame: T2(Day 20-23) - T0 (Day 4-6)
measure: Manual Muscle Testing (MMT)
timeFrame: T1 (Day 12-14) - T0 (Day 4-6)
measure: Modified Ashworth Scale (MAS)
timeFrame: T2(Day 20-23) - T0 (Day 4-6)
measure: Modified Ashworth Scale (MAS)
timeFrame: T1 (Day 12-14) - T0 (Day 4-6)
measure: 9 Hole Peg Test (9HPT)
timeFrame: T2(Day 20-23) - T0 (Day 4-6)
measure: 9 Hole Peg Test (9HPT)
timeFrame: T1 (Day 12-14) - T0 (Day 4-6)
Secondary outcomes:
measure: GG Scores for Self-Care Items
timeFrame: Change from admission to discharge, up to 55 days
measure: GG Scores for Mobility items
timeFrame: Change from admission to discharge, up to 55 days
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Gaylord Hospital
state: Connecticut
city: Schenectady
country: United States
facility: Sunnyview Rehabilitation Hospital
state: New York
Study officials:
affiliation: Sunnyview Rehabilitation Hospital
name: Casey Cowan, MS OTR/L
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnyview Rehabilitation Hospital
name: Emily Steenburgh, MS OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/
citation: Zelter L. 2010. Motor Assessment Scale (MAS). https://strokengine.ca/en/assessments/motor-assessment-scale-mas/#:~:text=The%20Motor%20Assessment%20Scale%20(MAS,leakage%20from%20a%20blood%20vessel.
citation: Figueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/
citation: Figueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/