NCT05401799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

May 10, 2022

Last Update Submit

May 16, 2025

Conditions

StrokeStroke, AcuteCerebral Vascular AccidentCerebral Vascular Accident (CVA)/Stroke

Keywords

BURTUpper extremity functionInpatient rehabilitationUpper extremity robotics

Outcome Measures

Primary Outcomes (8)

  • UE Motor Assessment Scale (UE-MAS)

    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)

    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)

    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)

    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)

    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)

    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)

    The 9HPT is a standardized test that measures manual dexterity.

    T2(Day 20-23) - T0 (Day 4-6)

  • 9 Hole Peg Test (9HPT)

    The 9HPT is a standardized test that measures manual dexterity.

    T1 (Day 12-14) - T0 (Day 4-6)

Secondary Outcomes (2)

  • GG Scores for Self-Care Items

    Change from admission to discharge, up to 55 days

  • GG Scores for Mobility items

    Change from admission to discharge, up to 55 days

Study Arms (2)

Conventional Upper Extremity Neuroeducation

ACTIVE COMPARATOR

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

BURT Upper Extremity

EXPERIMENTAL

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.

Device: BURTProcedure: Other Occupational Therapy

Interventions

BURTDEVICE

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

BURT Upper Extremity
Other Occupational TherapyPROCEDURE

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 ExtremityConventional Upper Extremity Neuroeducation

Eligibility Criteria

Age18 Years - 115 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient at Sunnyview Rehabilitation Hospital
  • \>/= 18 years
  • Unilateral stroke
  • UE paresis affected arm with 3-/5 or less manual muscle testing throughout

You may not qualify if:

  • \>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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Sunnyview Rehabilitation Hospital

Schenectady, New York, 12308, United States

Location

Related Publications (4)

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

    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.

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Casey Cowan, MS OTR/L

    Sunnyview Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

  • Emily Steenburgh, MS OTR/L

    Sunnyview Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

May 10, 2022

First Posted

June 2, 2022

Study Start

September 1, 2022

Primary Completion

February 17, 2025

Study Completion

February 17, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)