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Completed

NCT Number: NCT05401799

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

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.

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Key information

Age range

18 year–115 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaylord Hospital, Wallingford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BURT

Device

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

Other Occupational Therapy

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sunnyview Rehabilitation Hospital

Other

Collaborators

  • Gaylord Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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