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NCT05106595 · ClinicalTrials.gov registry record
Bimanual Arm Training in Acute Stroke
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 54
- Enrollment target
NCT05106595: Completed study, sponsored by Johns Hopkins University.
NCT05106595 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 54 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05106595 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 54 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DEVICE Bimanual Arm Trainer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2023-11-14 |
What the finished NCT05106595 record still lists
NCT05106595 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Bimanual Arm Trainer is the first listed.
NCT05106595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05106595 about?
NCT05106595 is a clinical study titled "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 ...
What is the current status of trial NCT05106595?
This trial is currently completed. The enrollment target is 54 participants. The study started on 2022-05-10. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT05106595?
The interventions under investigation include: Bimanual Arm Trainer (DEVICE).
Who is sponsoring clinical trial NCT05106595?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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