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

NCT ID: NCT05586490

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2023-12-14

Brief 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.

Detailed Description

The primary purpose of this feasibility study is to assess human user acceptance of the device during 2 lab sessions (aim 1) from which the persons will proceed to 5 lab sessions (aim 2) and during in-home use (aim 3). The in-home aim will also include control persons to allow exploratory collection of clinical data that may provide preliminary outcome data to properly power a future phase 2 randomized clinical trial. The open label extension will provide information on the efficacy of using the device long-term.

While 45 persons may appear to be a larger than normal number for a device feasibility trial, because Parkinsons patients have a wide range of clinical symptoms, in order to acquire any meaningful data, some "spread" must be achieved. For example, 3 individuals in several different symptomatic categories. Further, there is some chance of attrition. Lastly, to be clear, details of device design may continue to be modified throughout the study.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP)

Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use the experimental device in home feasibility testing (aim 3). This arm will be asked to participate in the open label extension.

Group Type: EXPERIMENTAL

Multifunctional RehabilitationDevice (MRD)

Intervention Type: DEVICE

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

In-home feasibility testing (alternate device)

Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2).

This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension.

Group Type: ACTIVE_COMPARATOR

Multifunctional RehabilitationDevice (MRD)

Intervention Type: DEVICE

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

existing standard rehabilitation device

Intervention Type: DEVICE

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

In-home feasibility testing (no device in at home portion)

Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3)

Group Type: OTHER

Multifunctional RehabilitationDevice (MRD)

Intervention Type: DEVICE

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

Interventions

Multifunctional RehabilitationDevice (MRD)

Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP

Intervention Type: DEVICE

existing standard rehabilitation device

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

Intervention Type: DEVICE

Other Intervention Names

MRD

Eligibility Criteria

Inclusion Criteria

• Parkinson's disease
• Willing and able to comply with study requirements

Exclusion Criteria

• Parkinson's disease dementia
• Parkinsonism plus syndromes
• Inability to stand, step, or walk without an assistive device
• History of symptoms in stance that preclude safe and comfortable participation, such as severe dizziness and lightheadedness, severe orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema, or medication side effects
• History of symptomatic cardiovascular or pulmonary disease interfering with stance
• History of active rheumatic arthritis
• History of uncontrolled chronic pain syndrome
• Any other history of medical or psychiatric comorbidity precluding safe participation in the project
• Venous stasis or severe varicosities

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Chatkaew Pongmala

Research Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chatkaew Pongmala, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R41NS1129418

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00216022a

Identifier Type: -

Identifier Source: org_study_id