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

NCT ID: NCT05401799

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-02-17

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Other Occupational Therapy

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

BURT

Intervention Type: DEVICE

Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.

Other Occupational Therapy

Intervention Type: PROCEDURE

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.

Interventions

BURT

Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.

Intervention Type: DEVICE

Other Occupational Therapy

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 115 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaylord Hospital

UNKNOWN

Sponsor Role: collaborator

Sunnyview Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Casey Cowan

Occupational Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Casey Cowan, MS OTR/L

Role: PRINCIPAL_INVESTIGATOR

Sunnyview Rehabilitation Hospital

Emily Steenburgh, MS OTR/L

Role: PRINCIPAL_INVESTIGATOR

Sunnyview Rehabilitation Hospital

Locations

Gaylord Hospital

Wallingford, Connecticut, United States

Sunnyview Rehabilitation Hospital

Schenectady, New York, United States

Countries

United States

References

Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Figueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/

Reference Type: BACKGROUND

Figueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/

Reference Type: BACKGROUND

Other Identifiers

22-0324-1

Identifier Type: -

Identifier Source: org_study_id