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