MedDataX Logo

Feasibility Study on PoRi Device

NCT ID: NCT06842901

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2025-07-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hand Spasticity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study population only includes participants who present for follow up management of hand spasticity at the Yale New Haven Hospital's Physical Medicine and Rehabilitation (PM\&R) outpatient clinic or who are admitted to the Yale New Haven Hospital's Inpatient Rehabilitation Unit (IRU).
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Portable Rehabilitation (PoRi) device

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Necolle Morgado-Vega

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

New Haven, Connecticut, United States

Site Status

Yale New Haven Hospital's Inpatient Rehabilitation Unit

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2000039568

Identifier Type: -

Identifier Source: org_study_id