Post Stroke, Post Stroke Hand Rehabilitation
Conditions
Keywords
sensorimotor hand dysfunction
Brief summary
This randomized clinical trial compares the Portable Rehabilitation Interface (PoRI) device for rehabilitation of hand motor function in post-stroke patients with conventional hand therapy.
Interventions
DEVICEPortable Rehabilitation Interface (PoRI)
Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study population only includes patients who present for follow up management of sensorimotor hand dysfunction (muscle strength less than or equal to 3/5) at the Yale New Haven Hospital's Physical Medicine & Rehabilitation (PM&R) department's Inpatient Rehabilitation Unit.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Between 2 days and a maximum of 2 months have passed since the stroke event * 0-3/5 muscle strength * Participants with paralysis or sensorimotor function problems of the fingers of one or both hands. * Participants must be able to fit their hand comfortably into the device.
Exclusion criteria
* Less than 2 days or greater than 2 months have passed since the stroke event * 4-5/5 muscle strength * Vulnerable populations. * Inability of fingers and wrist to stretch to neutral during passive range of motion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA) score | Baseline and Week 2-3 | Fugl-Meyer Assessment (FMA) score to assess function with a total score of 100 points. Higher scores mean better recovery, with 0-50 indicating severe impairment and 95-100 showing minimal impairment in motor function, guiding rehabilitation progress. |
| Box-and-Block Tests (BBT) score | Baseline and Week 2-3 | A Box-and-Block Test (BBT) score is the total number of small blocks a person moves from one section of a divided box to another within 60 seconds. More blocks moved equals greater dexterity. |
| Visual Analog Scale (VAS) Pain score | Baseline and Week 2-3 | The VAS pain scale is a tool for assessing pain intensity. Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 100: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-100) being the VAS pain score |
| Short Form McGill Pain Questionnaire (sfMPQ) score | Baseline and Week 2-3 | The sfMPQ is scored by summing the values of words that best describe a person's pain. The score ranges from 0 (no pain) to 45 (severe pain). |
| Mean Score Modified Ashworth Scale (MAS) | Baseline and Week 2-3 | MAS used to assess spasticity level with total score range 0-4. Higher scores indicate more rigidity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device usability and accessibility survey | Week 2-3 | Device usability and accessibility will be evaluated through a patient and researcher survey in the PoRi arm.. |
Countries
United States
Contacts
CONTACTNecolle Morgado-Vega
CONTACTGregory Roytman
PRINCIPAL_INVESTIGATORNecolle Morgado-Vega
Yale University
Outcome results
None listed