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

February 16, 2024 updated by: Casey Cowan, Sunnyview Rehabilitation Hospital

Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • Wallingford, Connecticut, United States, 06492
        • Enrolling by invitation
        • Gaylord Hospital
    • New York
      • Schenectady, New York, United States, 12308
        • Recruiting
        • Sunnyview Rehabilitation Hospital
        • Principal Investigator:
          • Casey Cowan, MS OTR/L
        • Sub-Investigator:
          • Emily Steenburgh, MS OTR/L
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 115 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: 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.
Experimental: 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.
Procedure: 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.
Device: BURT
Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UE Motor Assessment Scale (UE-MAS)
Time Frame: T2(Day 20-23) - 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.
T2(Day 20-23) - T0 (Day 4-6)
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.
T1 (Day 12-14) - T0 (Day 4-6)
Manual Muscle Testing (MMT)
Time Frame: T2(Day 20-23) - 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.
T2(Day 20-23) - T0 (Day 4-6)
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.
T1 (Day 12-14) - T0 (Day 4-6)
Modified Ashworth Scale (MAS)
Time Frame: T2(Day 20-23) - T0 (Day 4-6)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
T2(Day 20-23) - T0 (Day 4-6)
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.
T1 (Day 12-14) - T0 (Day 4-6)
9 Hole Peg Test (9HPT)
Time Frame: T2(Day 20-23) - T0 (Day 4-6)
The 9HPT is a standardized test that measures manual dexterity.
T2(Day 20-23) - T0 (Day 4-6)
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.
T1 (Day 12-14) - T0 (Day 4-6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GG Scores for Self-Care Items
Time Frame: Change from admission to discharge, up to 55 days
standardized assessments of functional independence for feeding, bathing, toileting, footwear, upper and lower body dressing and oral hygiene.
Change from admission to discharge, up to 55 days
GG Scores for Mobility items
Time Frame: Change from admission to discharge, up to 55 days
standardized assessments of functional independence for bed mobility and transfers.
Change from admission to discharge, up to 55 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnyview Rehabilitation Hospital

Collaborators

Gaylord Hospital

Investigators

  • Principal Investigator: Casey Cowan, MS OTR/L, Sunnyview Rehabilitation Hospital
  • Principal Investigator: Emily Steenburgh, MS OTR/L, Sunnyview Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/
  • 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.
  • Figueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/
  • Figueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0324-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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