Post StrokeNCT07407023
PoRI Clinical Trial
A study testing Portable Rehabilitation Interface (PoRI) in people with Post Stroke and Post Stroke Hand Rehabilitation, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Stroke, Post Stroke Hand Rehabilitation
- What is being tested?
- Portable Rehabilitation Interface (PoRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital's Inpatient Rehabilitation Unit
Milford, Connecticut, 06460
About this study
Official title: Randomized Clinical Trial of (PoRI) Post-Stroke Hand Rehabilitation Device
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.
- Conditions
- Post Stroke, Post Stroke Hand Rehabilitation
- Being tested
- Portable Rehabilitation Interface (PoRI)
- Keywords
- sensorimotor hand dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable Rehabilitation Interface (PoRI)Device
Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Portable Rehabilitation Interface (PoRI) |
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: Baseline and Week 2-3
Secondary outcomes (1)
Device usability and accessibility survey
Device usability and accessibility will be evaluated through a patient and researcher survey in the PoRi arm..
Measured: Week 2-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start23 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post StrokeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Necolle Morgado-Vega, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407023
- Sponsor's protocol ID
- 2000041770
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of (PoRI) Post-Stroke Hand Rehabilitation Device
- ClinicalTrials.gov ID
- NCT07407023
- Acronym / sponsor ID
- 2000041770
- Conditions
- Post Stroke, Post Stroke Hand Rehabilitation
- Keywords
- sensorimotor hand dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Portable Rehabilitation Interface (PoRI) + Conventional Therapy | Experimental | Device: Portable Rehabilitation Interface (PoRI)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. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable Rehabilitation Interface (PoRI)Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction | Device | Portable Rehabilitation Interface (PoRI) + Conventional Therapy |
Primary outcome
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.
1 secondary outcome
Device usability and accessibility survey
Time frame: Week 2-3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Necolle Morgado-Vega principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable Rehabilitation Interface (PoRI) in people with Post Stroke and Post Stroke Hand Rehabilitation, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Necolle Morgado-Vega (203-843-5733, necolle.morgado-vega@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) score (time frame: Baseline and Week 2-3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.