NCT05106595Completed
Bimanual Arm Training in Acute Stroke
Use of a Bimanual Arm Training Device in Acute Inpatient Stroke Rehabilitation, a Pre-post Cohort Study
Source: ClinicalTrials.gov · Last updated 18 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 54 (actual)
- First submitted
- 20 Oct 2021
- Start date
- 10 May 2022
- Primary completion date
- 14 Nov 2023
- Lead sponsor
- Johns Hopkins University
- Diseases
- Stroke
- NCT number
- NCT05106595
What you commit to
- Study type: Observational
- Participants enrolled: 54
- From 10 May 2022 to the primary completion date, 14 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- Diagnosis of acute stroke.
- Score of \<17 on admission ARAT.
- Participation ≥ 3 BAT training sessions.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Specialty Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.