Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
Study Overview
Brief Summary
This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone. The device's ability to improve spasticity before and after a 20-minute session with the device at Yale New Haven Hospital's outpatient clinic of Physical Medicine & Rehabilitation, or the Inpatient Rehabilitation Unit.
Detailed Description
Each patient will participate in a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and to measure the Modified Ashworth Score (MAS) before and after the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Modified Ashworth Scale (MAS) score of at least 1
- •Participants with paralysis or motor function problems of the fingers of one or both hands.
Exclusion Criteria
- •Minors (below age 18)
- •Vulnerable populations
- •Inability of fingers and wrist to stretch to neutral during passive range of motion
Arms & Interventions
Hand Spasticity
Each participant will have a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and data collection.
Intervention: Portable Rehabilitation (PoRi) device (Device)
Outcomes
Primary Outcomes
Feasibility assessed using the change in Modified Ashworth Scale (MAS) score
Time Frame: immediately prior to intervention session and immediately following 20 minute intervention session
Muscle tone is rated on a 6-point scale (0, 1, 1+, 2, 3, 4) with higher scores indicating greater spasticity.
Secondary Outcomes
- Device usability and accessibility survey(immediately following 20 minute intervention session)