Post-Physical Therapy Extension of In-Home Dynamic Standing Table Use in Parkinson Disease
|ClinicalTrials.gov Identifier: NCT03045211|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Dynamic Standing Table||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Post-Physical Therapy Extension of In-Home Dynamic Standing Table Use in Parkinson Disease|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: In-Home Standing Table
Participants in this arm will receive a dynamic standing table to be used in their home for at least two hours per day for at least five days per week for a 16-week period. Specific activities will be tracked with a logbook. PD subjects will be coached by a physical therapist on proper body positioning at the table, use of anti-fatigue mat, and optimal monitor height. The physical therapist will adhere to the "neutral body positioning" guidelines as provided by the OSHA. The physical therapist will also perform an in-home safety assessment of the office or room in which the table will be placed to ensure safety not only for the users but also for family members or children. The physical therapist will monitor each participant throughout the study by making biweekly compliance phone calls.
In addition, this group will received standard of care, which is weekly group exercise sessions during the 16-week period of table use.
Device: Dynamic Standing Table
The dynamic standing table is a height-adjustable standing table with an oscillating tabletop system. The tabletop system moves automatically and slowly (velocity of approximately 3 mm/s) from side-to-side in the horizontal plane (in a linear movement pattern) and facilitates stepping by the user to stay centered in front of the working table surface.
No Intervention: Standard of Care
this group will received standard of care only, which is weekly group exercise sessions during a 16-week period. Instructions, coaching, and compliance phone calls will also be provided to the participants of this arm such that both arms have the same amount of contact time with the physical therapist.
- Change in stride velocity during the instrumented Timed Up and Go test from week 6 to week 23 [ Time Frame: At week 6 (post-physical therapy); at week 23 (post 16-week table intervention) ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045211
|United States, Michigan|
|University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Nicolaas Bohnen, MD PhD||University of Michigan|