Hand Spasticity
Conditions
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.
Interventions
DEVICEPortable Rehabilitation (PoRi) device
Once the calibration is complete, the device moves the fingers to close and open the hand for a total of 20 minutes.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The study population only includes participants who present for follow up management of hand spasticity at the Yale New Haven Hospital's Physical Medicine and Rehabilitation (PM&R) outpatient clinic or who are admitted to the Yale New Haven Hospital's Inpatient Rehabilitation Unit (IRU).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility assessed using the change in Modified Ashworth Scale (MAS) score | 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
| Measure | Time frame | Description |
|---|---|---|
| Device usability and accessibility survey | immediately following 20 minute intervention session | Device usability and accessibility will be evaluated through a patient and researcher survey. |
Countries
United States
Outcome results
None listed