Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease
Completed · Not applicable
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT05586490
- Run by
- University of Michigan
- People needed
- 38
- Starts
- 2022-10-13
- Expected to finish
- 2023-12-14
- Last updated by the study team
- 2025-01-14
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parkinson's disease
- Willing and able to comply with study requirements
You may not qualify if…
- 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
Where it is running
- The University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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