PoRI Clinical Trial

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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)
  • Device: Portable Rehabilitation Interface (PoRI)
    Handheld device known as the Portable Rehabilitation Interface (PoRI) that moves the hand of patients with sensorimotor hand dysfunction

Recruiting Locations

Yale New Haven Hospital's Inpatient Rehabilitation Unit
Milford, Connecticut 06460

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Necolle Morgado-Vega
203-843-5733
necolle.morgado-vega@yale.edu