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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portable Rehabilitation Interface (PoRI) + Conventional Therapy | Experimental | Participants will receive seven 20-minute sessions with the PoRI device within 10 days during the course of care in addition to conventional therapy (standard of care) for 1 hour per day, 5 days per week for 2 to 3 weeks. |
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| Conventional Therapy | No Intervention | Participants will receive 1 hour sessions, 5 days per week for 2 to 3 weeks using conventional therapy (standard of care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable Rehabilitation Interface (PoRI) | Device | Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (FMA) score | 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. | Baseline and Week 2-3 |
| Box-and-Block Tests (BBT) score | 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. | Baseline and Week 2-3 |
| Visual Analog Scale (VAS) Pain score | 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 | Baseline and Week 2-3 |
| Short Form McGill Pain Questionnaire (sfMPQ) score | 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). | Baseline and Week 2-3 |
| Mean Score Modified Ashworth Scale (MAS) | MAS used to assess spasticity level with total score range 0-4. Higher scores indicate more rigidity. | Baseline and Week 2-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Device usability and accessibility survey | Device usability and accessibility will be evaluated through a patient and researcher survey in the PoRi arm.. | Week 2-3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Necolle Morgado-Vega | Contact | 203-843-5733 | necolle.morgado-vega@yale.edu | |
| Gregory Roytman | Contact | 815-382-0687 | gregory.roytman@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Necolle Morgado-Vega | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital's Inpatient Rehabilitation Unit | Recruiting | Milford | Connecticut | 06460 | United States |
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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.
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