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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045211
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Nicolaas Bohnen, MD, PhD, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Dynamic Standing Table Not Applicable

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 has developed a sit-stand desk system that enhances upright standing activity with weight-shifting movements. The "dynamic standing table" has a tabletop that oscillates in the horizontal plane, which cues users to make periodic side-to-side body weight shifting adjustments. 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. Preliminary data shows that patients with moderate PD can complete sessions of at least 3 hours without significant difficulty and may have motor and cognitive benefits from using this table. 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. The incremental addition of the dynamic table use is expected to more effectively reduce post-physical therapy sedentary behavior compared to the standard of care alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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 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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045211


Locations
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United States, Michigan
University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Nicolaas Bohnen, MD PhD University of Michigan

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Responsible Party: Nicolaas Bohnen, MD, PhD, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03045211    
Other Study ID Numbers: HUM00118467
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases