Treadmill Training in People With Parkinson's Disease

NCT05239026 | Completed

• 1 other identifier: H22192
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study will explore if coupling speed and cadence during treadmill training elicit more benefits than controlling speed alone in individuals with Parkinson's disease.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Gait Speed Determined based on the Time Measured by A Stop Watch and the 10-meter Walking Distance at Post-intervention Assessment Which Is about One Hour Later Than the Baseline Test.

  Gait speed will be calculated as the 10-meter walking distance divided by the time used to cover this distance and reported in meters/second. A 10-meter walkway is valid and reliable as an assessment of gait speed. A stop watch is a valid and reliable way to measure the walking time.

  Baseline and post-intervention (about 1 hour following the baseline)

Secondary Outcomes (4)

• Change from Baseline in the Step Length Determined by the Vicon Motion Capture System at Post-intervention Assessment Which Is about One Hour Later Than the Baseline Test.

  Baseline and post-intervention (about 1 hour following the baseline)

• Change from Baseline in the Step Cadence as Assessed by the Vicon Motion Capture System at Post-intervention Assessment Which Is about One Hour Later Than the Baseline Test.

  Baseline and post-intervention (about 1 hour following the baseline)

• Change from Baseline in Dynamic Gait Stability Assessed by the Feasible Stability Region Theory at Post-intervention Assessment Which Is about One Hour Later Than the Baseline Test.

  Baseline and post-intervention (about 1 hour following the baseline)

• Change from Baseline in Ground Reaction Force Assessed by Force Plates at Post-intervention Assessment Which Is about One Hour Later Than the Baseline Test.

  Baseline and post-intervention (about 1 hour following the baseline)

Study Arms (2)

Advanced Training Group

EXPERIMENTAL

This arm will receive a single session treadmill training session in which both cadence and treadmill speed are controlled.

Behavioral: Advanced treadmill walking

Traditional Training Group

EXPERIMENTAL

This arm will receive a single session treadmill training session in which only treadmill speed is controlled.

Behavioral: Traditional treadmill walking

Interventions

Advanced treadmill walking BEHAVIORAL

Participants will walking on a treadmill for 6 5-minute Blocks. The cadence will be progressively reduced for the first 3 Blocks. Speed will progressively increase during Blocks 4-6 while cadence from Block 3 is maintained.

Advanced Training Group

Traditional treadmill walking BEHAVIORAL

Participants will walking on a treadmill for 6 5-minute Blocks. Participants will walk at self-selected cadence during Blocks 1-3. Speed will progressively increase during Blocks 4-6.

Traditional Training Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can read and understand English
• Between the ages of 18-89 years old
• Diagnosed with Parkinson's Disease
• Stage 1-3 based on the Hoehn and Yahr
• Able to walk overground more than 15m independently
• Able to walk on a treadmill for at least 15 minutes independently

You may not qualify if:

• Diagnosed with any uncontrolled cardiorespiratory or metabolic disease
• Experience any other known neurologic disorders that affect their ability to walk
• Diagnosed with any visual or communication disorders
• Suffered a lower extremity injury within the last 6 months

Sponsors & Collaborators

• Georgia State University: lead

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, 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

• Feng Yang, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 14, 2022
• Study Start: March 21, 2022
• Primary Completion: May 31, 2024
• Study Completion: July 9, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)