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

NCT03045211 | Completed

• 1 other identifier: HUM00118467
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

In-Home Standing Table

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Dynamic Standing Table DEVICE

The dynamic standing table is a height-adjustable standing table which gives periodic cues to the user to make stepping movements.

In-Home Standing Table

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Functional Neuroimaging, Cognitive and Mobility Laboratory

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nicolaas Bohnen, MD PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 7, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)