Feasibility Study on PoRi Device

December 17, 2025 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • , Yale New Haven Hospital's Physical Medicine & Rehabilitation (PM&R) outpatient clinic
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital's Inpatient Rehabilitation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand Spasticity
Each participant will have 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 data collection.
Device: Portable Rehabilitation (PoRi) device
Once the calibration is complete, the device moves the fingers to close and open the hand for a total of 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately prior to intervention session and immediately following 20 minute intervention session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately following 20 minute intervention session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Necolle Morgado-Vega, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000039568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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