- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05239026
Treadmill Training in People With Parkinson's Disease
May 31, 2023 updated by: Feng Yang, PhD, Georgia State University
Treadmill Training With Concurrently Controlled Speed and Cadence 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Feng yang, PhD
- Phone Number: 404-413-8357
- Email: fyang@gsu.edu
Study Contact Backup
- Name: Rebecca Ban, MS
- Email: rban1@student.gsu.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Recruiting
- Georgia State University
-
Contact:
- Feng yang, PhD
- Phone Number: 404-413-8357
- Email: fyang@gsu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Advanced Training Group
This arm will receive a single session treadmill training session in which both cadence and treadmill speed are controlled.
|
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.
|
Experimental: Traditional Training Group
This arm will receive a single session treadmill training session in which only treadmill speed is controlled.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and post-intervention (about 1 hour following the baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and post-intervention (about 1 hour following the baseline)
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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.
|
Baseline and post-intervention (about 1 hour following the baseline)
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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)
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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.
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Baseline and post-intervention (about 1 hour following the baseline)
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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)
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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.
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Baseline and post-intervention (about 1 hour following the baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Feng Yang, PhD, Georgia State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2022
Primary Completion (Estimated)
October 30, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
January 6, 2022
First Submitted That Met QC Criteria
February 3, 2022
First Posted (Actual)
February 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2023
Last Update Submitted That Met QC Criteria
May 31, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H22192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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