Parkinson Disease Clinical Trial
Official title:
Post-Physical Therapy Extension of In-Home Dynamic Standing Table Use in Parkinson Disease
NCT number | NCT03045211 |
Other study ID # | HUM00118467 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | April 2020 |
Verified date | September 2020 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
When postural imbalance and gait difficulties emerge in subjects with Parkinson disease, patients are typically referred for a number of physical therapy sessions. However, there is a critical gap in clinical practice on what to do once patients have completed their therapy sessions. To fill this gap, the study team has developed a standing table with a tabletop system that encourages weight shifting during upright standing ("dynamic standing table"), and therefore may be a unique means to increase daily physical activity by integrating the system with routine desktop activities of daily living. The purpose of this study is to determine whether a post-physical therapy in-home physical activity program using the dynamic standing table (as an adjunct to post-physical therapy standard of care-weekly physical activity group sessions) is effective in sustaining the mobility benefits of physical therapy in individuals with Parkinson disease.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - Presence of Parkinson's disease. PD diagnosis following the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD, consistent with the typical nigrostriatal denervation pattern on VMAT2. - Hoehn and Yahr stages 2-4 and/or presence of PIGD features, such as history of (near) falls, slow gait, and/or freezing of gait. - Available space to place table in their home (approximately 6 ft x 5 ft area). Exclusion Criteria: - Inability to stand or walk without an assistive device. - History of symptoms in stance that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain. - History of significant symptomatic cardiovascular or pulmonary disease. - History of active symptomatic rheumatic arthritis. - History of stroke or other focal brain conditions with residual sensorimotor deficits interfering with stance functions. - History of chronic pain syndrome requiring daily narcotic analgesics. - Evidence of dementia. - Venous stasis or severe varicosities |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in stride velocity during the instrumented Timed Up and Go test from week 6 to week 23 | Instrumented Timed Up and Go, Subject starts in seated position rises from chair and walks 3 meters, then returns to chair in a seated position | At week 6 (post-physical therapy); at week 23 (post 16-week table intervention) |
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