PoRI Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Post Stroke; Post Stroke Hand Rehabilitation
• Intervention / Treatment: Device: Portable Rehabilitation Interface (PoRI)

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Necolle Morgado-Vega; Phone Number: 203-843-5733; Email: necolle.morgado-vega@yale.edu
• Study Contact Backup: Name: Gregory Roytman; Phone Number: 815-382-0687; Email: gregory.roytman@yale.edu

Study Locations

• United States
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Recruiting
      • Yale New Haven Hospital's Inpatient Rehabilitation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable Rehabilitation Interface (PoRI) + Conventional Therapy; 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); Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction
No Intervention: Conventional Therapy; Participants will receive 1 hour sessions, 5 days per week for 2 to 3 weeks using conventional therapy (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Necolle Morgado-Vega, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: sensorimotor hand dysfunction
• Other Study ID Numbers: 2000041770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No