Genetic Influences on Response to Gait Rehabilitation in Parkinson's Disease

NCT03607695 | Completed Results

• 2 other identifiers: E2553-PI21RX002553-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The aging Veteran population, together with high exposure to Agent Orange or other herbicides during military service, has made diseases such as Parkinson's disease (PD), currently affecting more than 80,000 Veterans, a major health issue in the Veterans' health system. Mobility and cognitive limitations are a common problem in PD and are associated with significant disability, increased fall risk, reduced quality of life, and increased caregiver burden. While less is known about its benefit on cognition, physical therapy has proven to be an effective treatment to mitigate mobility limitations, though the response to rehabilitation interventions is highly variable. The proposed research will inform the investigators' understanding of the impact of certain genetic profiles associated with learning impairments on motor and cognitive benefits in response to gait rehabilitation, and will provide an important foundation for more personalized and improved gait rehabilitation programs for different subgroups of PD patients.

Conditions

Parkinson's Disease

Keywords

gait; exercise; cognition; genetics

Outcome Measures

Primary Outcomes (2)

• Gait Speed (m/s)

  The investigators will use the APDM Movement Monitoring system to assess gait speed (m/s) during straight-line walking as a measure of gait function.

  measured at baseline, 2 weeks, 10 weeks and 16 weeks

• Montreal Cognitive Assessment Score

  The investigators will use the Montreal Cognitive Assessment (MoCA; score range=0-30, with 30 indicating better cognitive function) as a reflection of global cognitive function

  measured at baseline and at 10 weeks

Study Arms (1)

Gait training

EXPERIMENTAL

1 hour walking exercise on a treadmill

Other: Gait training

Interventions

Gait training OTHER

Walking on a treadmill and receiving audio cues to improve gait

Gait training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Have a Hoehn \& Yahr score of 3
• Have the ability to walk 400 m without physical assistance from a device or another person
• Do not have other health conditions (e.g., orthopedic, cardiopulmonary) that impact the ability to safely participate in a moderately intense gait training program
• The investigators will exclude those patients presenting clinical diagnosis of dementia.
• The investigators will exclude those patients presenting conditions (cardiac, renal, or metabolic) that would pose a risk to their health by exercising.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Washington: collaborator

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This trial was impacted by local and institutional restrictions on research implemented during the start of the COVID-19 pandemic. Restrictions on research activities impacted recruitment and impacted data collection for some participants.

Results Point of Contact

• Title: Valerie E. Kelly, PT, PhD
• Organization: University of Washington

vekelly@uw.edu

206-598-5350

Study Officials

• Ignacio Fernandez-Mata

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The intervention is a 10-week gait, treadmill-training program. The sessions are 1 hour long, twice a week.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: July 31, 2018
• Study Start: February 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 27, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)