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Recruiting NCT07407023

PoRI Clinical Trial

No phase Interventional Post Stroke Post Stroke Hand Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Portable Rehabilitation Interface (PoRI).
Who it may be relevant to
Registry conditions: Post Stroke, Post Stroke Hand Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Clinical Trial of (PoRI) Post-Stroke Hand Rehabilitation Device

Overview

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.

Interventions

  • Device 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 measures

  • 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]
Secondary outcome measures (1)
  • Device usability and accessibility survey [Time frame: Week 2-3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Yale New Haven Hospital's Inpatient Rehabilitation Unit — Milford

Identifiers

NCT: NCT07407023 · 2000041770

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗