Clinical trial NCT03045211: Post-Physical Therapy Extension of In-Home Dynamic Standing Table Use in Parkinson Disease
Official title: Post-Physical Therapy Extension of In-Home Dynamic Standing Table Use in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Axial motor dysfunctions in Parkinson disease (PD) are least responsive to dopaminergic therapy and incline many patients towards a sedentary lifestyle. This places PD patients at increased risk for the negative consequences of physical inactivity. When PD patients develop postural imbalance and gait difficulties, including falls, they are generally referred to physical therapy for optimal management. Although these patients do benefit from physical therapy, there is a critical gap in clinical practice on what to do next once the physical therapy sessions are over. Clinical experience shows that most patients return to a sedentary lifestyle indicating an urgent need for post-physical therapy in-home physical activity programs in PD with postural imbalance and gait difficulties to preserve mobility functions. Recent advances in physical activity research tout non-exercise physical activity approaches to promote healthy lifestyle modifications. Non-exercise physical activities are activities of daily living, like cleaning, shopping, and standing, other than intentional exercise. For PD patients with postural imbalance and gait difficulties, normal upright standing and weight-shifting (stepping) for longer periods of time may be an ideal form of non-exercise physical activity. It activates lower extremity muscles and encourages postural activity. To promote this type of non-exercise physical activity, the study team applies a "dynamic standing table", which periodically cues users to make steps. Dynamic standing would represent a minimal level of physical activity compared to sitting, which is pervasive in PD subjects with postural imbalance and gait difficulties. Use of the dynamic standing table can easily be incorporated with routine desktop activities, such as computer use, reading, or watching TV and may promote physical activity. 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 compared with post-physical activity standard of care alone in individuals with Parkinson disease and postural imbalance and gait difficulties. The study team is testing the exploratory hypothesis that post-physical therapy gains in mobility functions in PD patients with postural imbalance and gait difficulties will be preserved better with in-home dynamic standing table use compared to a control group. After consulting with regulatory specialists, this device was determined to be 510k exempt and falls under part 890 Physical Medicine devices Subpart F- Physical Medicine therapeutic devices. Sec. 890.5370 Nonmeasuring exercise equipment.

Eligibility criteria: 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

Primary outcomes:
measure: Change in stride velocity during the instrumented Timed Up and Go test from week 6 to week 23
timeFrame: At week 6 (post-physical therapy); at week 23 (post 16-week table intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nicolaas Bohnen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: