NCT07407023 · Yale University
PoRI Clinical Trial
What this study is about
This randomly assigned clinical trial compares the Portable Rehabilitation Interface (PoRI) device for rehabilitation of hand motor function in post-stroke patients with conventional hand therapy.
View original scientific description
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
DEVICE
Portable Rehabilitation Interface (PoRI)
Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction
Primary outcome measures
Fugl-Meyer Assessment (FMA) score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline and Week 2-3
MAS used to assess spasticity level with total score range 0-4. Higher scores indicate more rigidity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Milford, Connecticut
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations