Post-Physical Therapy Extension of In-Home Dynamic Standing Table Use in Parkinson Disease

Parkinson Disease

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.

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.

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United States