BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation

Sunnyview Rehabilitation Hospital

Status: Completed

Conditions: Cerebral Vascular Accident; Stroke; Stroke, Acute; Cerebral Vascular Accident (CVA)/Stroke

Treatments: Device: BURT; Procedure: Other Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05401799

22-0324-1

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 115 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

82 participants in 2 patient groups

Conventional Upper Extremity Neuroeducation

Active Comparator group

Description:

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

Treatment:

Procedure: Other Occupational Therapy

BURT Upper Extremity

Experimental group

Description:

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.

Treatment:

Procedure: Other Occupational Therapy

Device: BURT