Health TrialsbyHealthPanel

PoRI Clinical Trial

ConditionsPost StrokePost Stroke Hand Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Portable Rehabilitation Interface (PoRI)

    Device

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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Portable Rehabilitation Interface (PoRI) + Conventional TherapyExperimental treatment 1 intervention
Group B: Conventional TherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and Week 2-3
2

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.

Time frame
Baseline and Week 2-3
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

Time frame
Baseline and Week 2-3
4

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).

Time frame
Baseline and Week 2-3

Secondary outcomes

1

Device usability and accessibility survey

Device usability and accessibility will be evaluated through a patient and researcher survey in the PoRi arm..

Time frame
Week 2-3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov
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