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OpenTrials
Completed

NCT Number: NCT06842901

Feasibility Study on PoRi Device

This study is a feasibility study of a new device that moves the hand of patients with spasticity to reduce hand muscle tone. The device's ability to improve spasticity before and after a 20-minute session with the device at Yale New Haven Hospital's outpatient clinic of Physical Medicine & Rehabilitation, or the Inpatient Rehabilitation Unit.

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Key information

Conditions

Hand Spasticity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

, Yale New Haven Hospital's Physical Medicine & Rehabilitation (PM&R) outpatient clinic, New Haven, Connecticut, United States

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About this study

Each patient will participate in a single 20 minute session, during which the device will extend and flex finger muscles. Each participant's duration will be approximately 1 hour during clinic, including time to address any further questions, to calibrate the device, and to measure the Modified Ashworth Score (MAS) before and after the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Modified Ashworth Scale (MAS) score of at least 1
  • Participants with paralysis or motor function problems of the fingers of one or both hands.

Exclusion criteria

  • Minors (below age 18)
  • Vulnerable populations
  • Inability of fingers and wrist to stretch to neutral during passive range of motion

Treatment and study plan

Portable Rehabilitation (PoRi) device

Device

Once the calibration is complete, the device moves the fingers to close and open the hand for a total of 20 minutes.

Primary outcomes

  1. Feasibility assessed using the change in Modified Ashworth Scale (MAS) score

    Time frame: immediately prior to intervention session and immediately following 20 minute intervention session

    Muscle tone is rated on a 6-point scale (0, 1, 1+, 2, 3, 4) with higher scores indicating greater spasticity.

Secondary outcomes

  1. Device usability and accessibility survey

    Time frame: immediately following 20 minute intervention session

    Device usability and accessibility will be evaluated through a patient and researcher survey.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Feasibility Study on Portable Rehabilitation (PoRi) Device in Hand Spasticity

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Dec 19, 2025

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.