- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05106595
Bimanual Arm Training in Acute Stroke
Use of a Bimanual Arm Training Device in Acute Inpatient Stroke Rehabilitation, a Pre-post Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Specialty Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traditional Occupational Therapy
participants receiving traditional occupational therapy treatments and interventions provided in the inpatient rehabilitation setting.
This includes, but is not limited to , therapeutic activity, therapeutic exercise, neuromuscular re-education.
This group is retrospectively collected, and will not include participants who had access to the BAT.
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Bimanual Arm Trainer
Participants who are prospectively enrolled, who are appropriate for BAT use.
Participants will receive additional traditional occupational therapy interventions, as deemed appropriate by treating therapists.
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tabletop/desktop device that couples bilateral simultaneous upper extremity movement with virtual reality games or activities via computer monitor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Within 72 hours of admission and up to 72 hours of discharge for all participants
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Within 72 hours of admission and Up to 72 hours of discharge for all participants in the BAT group
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Babunovic, DPT, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00303045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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