Stroke, Acute Clinical Trial
Official title:
Use of a Bimanual Arm Training Device in Acute Inpatient Stroke Rehabilitation, a Pre-post Cohort Study
NCT number | NCT05106595 |
Other study ID # | IRB00303045 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 10, 2022 |
Est. completion date | November 14, 2023 |
Verified date | November 2023 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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 | Completed |
Enrollment | 54 |
Est. completion date | November 14, 2023 |
Est. primary completion date | November 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Specialty Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Action Research Arm Test score | 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. | Within 72 hours of admission and up to 72 hours of discharge for all participants | |
Secondary | Change in Upper Extremity Fugl-Meyer Assessment score | 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. | Within 72 hours of admission and Up to 72 hours of discharge for all participants in the BAT group |
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