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

University of Michigan

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: existing standard rehabilitation device; Device: Multifunctional RehabilitationDevice (MRD)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05586490

HUM00216022a

1R41NS1129418 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Multifunctional RehabilitationDevice (MRD)

In-home feasibility testing (alternate device)

Active Comparator group

Description:

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.

Treatment:

Device: Multifunctional RehabilitationDevice (MRD)

Device: existing standard rehabilitation device

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

Other group

Description:

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)

Treatment:

Device: Multifunctional RehabilitationDevice (MRD)