PoRI Clinical Trial

NCT07407023 | Recruiting FDA Device

• 1 other identifier: 2000041770
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Stroke; Post Stroke Hand Rehabilitation

Keywords

sensorimotor hand dysfunction

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (1)

• Device usability and accessibility survey

  Week 2-3

Study Arms (2)

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.

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)

Interventions

Portable Rehabilitation Interface (PoRI) DEVICE

Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction

Portable Rehabilitation Interface (PoRI) + Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 2 days and a maximum of 2 months have passed since the stroke event
• /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.

You may not qualify if:

• Less than 2 days or greater than 2 months have passed since the stroke event
• /5 muscle strength
• Vulnerable populations.
• Inability of fingers and wrist to stretch to neutral during passive range of motion

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital's Inpatient Rehabilitation Unit

Milford, Connecticut, 06460, United States

RECRUITING

Study Officials

• Necolle Morgado-Vega

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Necolle Morgado-Vega

CONTACT

203-843-5733; necolle.morgado-vega@yale.edu

Gregory Roytman

CONTACT

815-382-0687; gregory.roytman@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)