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Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease

NCT05586490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-01-14

Study results available
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Summary

The researchers have developed a multifunctional rehabilitation device that will be tested in this feasibility trial across three sub-studies: (i) dual session in-lab; (ii) multi-session in-lab and (iii) in the participant's home. A long-term outcome is to test possible benefits of this device (if accepted by the user Parkinson population) on motor and cognitive functions in a clinical trial in a future study. Participants who receive a device during the in-home trial will have the option to keep the device for up to two years in an open label extension. During this extension, participants can optionally provide feedback on their user experience such as discomfort.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Multifunctional RehabilitationDevice (MRD)

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

DEVICE

existing standard rehabilitation device

existing standard rehabilitation device to be used for in-home comparison testing for aim 3

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • Chatkaew Pongmala, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-12-14
Completion
2023-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586490 on ClinicalTrials.gov