Feasibility Study on PoRi Device

Yale University

Status: Completed

Conditions: Hand Spasticity

Treatments: Device: Portable Rehabilitation (PoRi) device

Study type: Interventional

Funder types: Other

Identifiers

NCT06842901

2000039568

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Hand Spasticity

Experimental group

Description:

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.

Treatment:

Device: Portable Rehabilitation (PoRi) device