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

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

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.

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.

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