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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Dynamic Standing Table

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 which gives periodic cues to the user to make stepping movements.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Nicolaas Bohnen, MD PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HUM00118467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No