Recruiting

PoRI vs. Conventional Therapy

Sponsor:

Yale University

Code:

NCT07407023

Conditions

Post Stroke

Post Stroke Hand Rehabilitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Portable Rehabilitation Interface (PoRI)

Study Details

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

Study ID

NCT07407023

Start date

Mar 23, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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)

Interventions

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 measure

  • Fugl-Meyer Assessment (FMA) score [ Time Frame: Baseline and Week 2-3 ]
  • Box-and-Block Tests (BBT) score [ Time Frame: Baseline and Week 2-3 ]
  • Visual Analog Scale (VAS) Pain score [ Time Frame: Baseline and Week 2-3 ]
  • Short Form McGill Pain Questionnaire (sfMPQ) score [ Time Frame: Baseline and Week 2-3 ]
  • Mean Score Modified Ashworth Scale (MAS) [ Time Frame: Baseline and Week 2-3 ]

Central Contacts and Locations

Central contacts

Necolle Morgado-Vega

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

Gregory Roytman

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

Locations

Yale New Haven Hospital's Inpatient Rehabilitation Unit

Recruiting

Milford, Connecticut, United States, 06460

More Information

Sponsor

Yale University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • sensorimotor hand dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-27.