Treadmill Training in People With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239026
• Other study ID #: H22192
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Georgia State University
• Contact: Feng Yang, PhD
• Phone: 404-413-8357
• Email: fyang[@]gsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Advanced treadmill walking
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
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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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.	Baseline and post-intervention (about 1 hour following the baseline)
Secondary	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.	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.	Baseline and post-intervention (about 1 hour following the baseline)
Secondary	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.	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.	Baseline and post-intervention (about 1 hour following the baseline)
Secondary	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.	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.	Baseline and post-intervention (about 1 hour following the baseline)