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Completed

NCT Number: NCT05106595

Bimanual Arm Training in Acute Stroke

Recent studies have shown that completing bilateral simultaneous movements during upper extremity practice may result in facilitation of coactivation and interhemispheric activation of both the ipsilesional and contralesional brain areas, with one limb entraining the other and enabling the limbs to function as a unit. Other research has proposed that the use of virtual-reality (VR) activities during treatment sessions can improve upper extremity function following stroke as it is motivating, challenging, offers external feedback that may facilitate motor learning, and allows for the "high-intensity, repetitious practice necessary to drive recovery". Coupling bilateral simultaneous upper extremity movement and virtual-reality activities is the Bimanual Arm Trainer (BAT), a non-powered mechanical device by which the non-paretic upper extremity moves the paretic arm. The purpose of this study is to determine the effectiveness of the Bimanual Arm Trainer (BAT) compared to traditional occupational therapy treatment sessions as these relate to upper extremity functional return following stroke, as measured by scores on the Action Research Arm Test (ARAT) and Upper Extremity Fugl-Meyer Assessment (UE-FMA) measures. The investigators plan to use retrospective data for a pre-implementation group, comparing this data to prospectively collected post-implementation data. ARAT scores are routinely collected and will be used for comparison between groups. UE-FMA measures are commonly used in this area of research, and will be taken to provide additional context for the post-implementation group.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Upper Extremity Paresis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Specialty Hospital

Baltimore, Maryland, 21224, United States

About this study

The medical charts of patients with a diagnosis of stroke will be reviewed retroactively to determine if there is a significant difference in improvement of upper extremity function (measured by ARAT and UE-FMA scores) following traditional occupational therapy services vs. use of the bimanual arm trainer. Medical charts of patients from November 2019 to November 2020 will be reviewed to obtain ARAT scores of patients who received traditional occupational therapy services. The Bimanual Arm Trainer was obtained in April 23, 2020; however, due to the pandemic, it was not able to be utilized until November 13, 2020. Patients from Review Board-approval onward will be assessed for ARAT and FMA-UE scores while using the device.

Duration: A minimum of 10 minutes for 3 separate sessions with Occupational Therapy for BAT participation. 15-30 minutes with Occupational Therapy (OT) within 3 days of admission and discharge for ARAT administration. The investigators anticipate that without mixed retrospective/prospective collection sample (post intervention application), the investigators will be able to reach the investigators' target participant number in 12 months after approval.

This study will not use a placebo or non-treatment group. The investigators will compare data retrospectively to patients who received standard care prior to the BAT being accessible within the investigators' rehabilitation department. Once the BAT was obtained and training occurred on the unit among staff members, the device was considered standard of care treatment to qualifying stroke patients; therefore, there is not a placebo group in the prospective portion of this study. Appropriate patient's will receive treatment sessions on the BAT regardless of participation in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of acute stroke.
  • Score of <17 on admission ARAT.
  • Participation ≥ 3 BAT training sessions.

Exclusion criteria

  • Impaired cognition impacting ability to participate in virtual reality system
  • Pain resulting in poor tolerance of range of motion.
  • Impaired sitting balance or poor tolerance of sitting in upright posture in chair without armrests.
  • Spasticity in the affected upper extremity Modified Ashworth Scale (MAS) of 3 or greater.

Treatment and study plan

Bimanual Arm Trainer

Device

tabletop/desktop device that couples bilateral simultaneous upper extremity movement with virtual reality games or activities via computer monitor

Primary outcomes

  1. Change in Action Research Arm Test score

    Time frame: Within 72 hours of admission and up to 72 hours of discharge for all participants

    a standardized tool that assesses UE functional limitations based off of 19 action-based items. Scores range from a minimum of 0 to a maximum of 57 points, with higher scores reflecting greater upper extremity functioning.

Secondary outcomes

  1. Change in Upper Extremity Fugl-Meyer Assessment score

    Time frame: Within 72 hours of admission and Up to 72 hours of discharge for all participants in the BAT group

    The UE-FMA is a body-functional level assessment of upper arm movement and sensation. Scores range from a minimum of o to a maximum of 66 points, with higher scores reflecting greater control of movement.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Use of a Bimanual Arm Training Device in Acute Inpatient Stroke Rehabilitation, a Pre-post Cohort Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2021
Registry last updated
Nov 18, 2023

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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