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Completed

NCT Number: NCT05239026

Treadmill Training in People With Parkinson's Disease

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

About this study

Impaired gait is prevalent and raises the fall risk in people with Parkinson's Disease (PwPD). Gait speed, step length, and cadence are three interrelated components of human gait, as speed is determined by step length and cadence. Auditory cues, such as metronomes, have been shown to aid training for PwPD. The purpose of this study is to examine if controlling cadence and speed improves overground gait parameters in PwPD better than only controlling speed. Two groups of PwPD will participate. Both groups will attend a single treadmill training session. Both groups will complete overground walking trials as a pre-test measurement. One group will receive treadmill training in which cadence, via a metronome, and speed are controlled, while only speed is controlled for the other group. Both groups will complete the same overground walking trials as a post-test measurements. The specific aim of this study is to determine the effects of metronome cues and gait speed versus gait speed alone treadmill training on spatiotemporal gait parameters when walking overground in PwPD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

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

    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.

Secondary outcomes

  1. 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.

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

    Step length, in meters, will be measured using a 9-camera Vicon motion capture system as the anteroposterior distance between heel markers at initial contact during overground walking. The Vicon motion capture system is valid and reliable to measure human body movement.

  2. 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.

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

    Step frequency is the number of steps taken during overground walking and reported as steps/min. The Vicon motion capture system is valid and reliable to counter the number of steps taken by a participant within a minute.

  3. 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.

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

    Dynamic gait stability is a unitless metric and will be calculated based on the Feasible Stability Region theoretical framework. The Feasible Stability Region framework has been valid and broadly used to quantify dynamic gait stability.

  4. 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.

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

    Ground reaction force will be be measured by two force plates (AMTI, MA) during overground walking and will be expressed in Newtons. AMTI force plates are valid and reliable to evaluate the ground reaction forces during human walking.

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Registry information

Official study title

Treadmill Training With Concurrently Controlled Speed and Cadence in People With Parkinson's Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2022
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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