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NCT Number: NCT07407023

PoRI Clinical 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.

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Key information

Conditions

Post Stroke Post Stroke Hand Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital's Inpatient Rehabilitation Unit

Milford, Connecticut, 06460, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portable Rehabilitation Interface (PoRI)

Device

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

Primary outcomes

  1. Fugl-Meyer Assessment (FMA) score

    Time frame: Baseline and Week 2-3

    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.

  2. Box-and-Block Tests (BBT) score

    Time frame: Baseline and Week 2-3

    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.

  3. Visual Analog Scale (VAS) Pain score

    Time frame: Baseline and Week 2-3

    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

  4. Short Form McGill Pain Questionnaire (sfMPQ) score

    Time frame: Baseline and Week 2-3

    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).

  5. Mean Score Modified Ashworth Scale (MAS)

    Time frame: Baseline and Week 2-3

    MAS used to assess spasticity level with total score range 0-4. Higher scores indicate more rigidity.

Secondary outcomes

  1. Device usability and accessibility survey

    Time frame: Week 2-3

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

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Roytman

CONTACT

[email protected]

815-382-0687

Necolle Morgado-Vega

CONTACT

[email protected]

203-843-5733

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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