PoRI Clinical Trial for Post-Stroke Hand Rehabilitation
This study is testing a handheld device called the Portable Rehabilitation Interface (PoRI) for people who have had a stroke and are experiencing problems with hand movement. The PoRI device helps move the hand to improve its function. Researchers want to see how well the PoRI device works compared to standard hand therapy. To join, you must be an adult (18 years or older) who has had a stroke within the last two months and has some paralysis or difficulty with hand movement. You also need to be able to comfortably fit your hand into the device. The study will measure success by looking at changes in hand function using tests like the Fugl-Meyer Assessment (FMA) and Box-and-Block Tests (BBT), as well as pain levels, over a period of 2-3 weeks. The current status of this study is unclear, and it plans to enroll 12 participants.
- Study design
- This is a randomized clinical trial, meaning participants will be assigned by chance to receive either the PoRI device or conventional hand therapy. It plans to enroll 12 participants.
- What's involved
- You would participate in assessments at the beginning of the study (Baseline) and again 2-3 weeks later. These assessments include tests of hand function and pain levels.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 2-3 weeks after the start of the study, based on the primary endpoint timeframes.
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PoRI Clinical Trial
At a glance
Conditions
NCT07407023
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Yale New Haven Hospital's Inpatient Rehabilitation Unit
Milford, Connecticutno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Necolle Morgado-Vega · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Inclusion
Exclusion
What this trial measures
- Fugl-Meyer Assessment (FMA) scoreBaseline 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) scoreBaseline 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 scoreBaseline 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) scoreBaseline 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.