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Treadmill Training in People With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced treadmill walking
Traditional treadmill walking
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georgia State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Advanced Training Group

Traditional Training Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 6, 2022
Last Updated
May 31, 2023
Sponsor
Georgia State University
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1. Study Identification

Unique Protocol Identification Number
NCT05239026
Brief Title
Treadmill Training in People With Parkinson's Disease
Official Title
Treadmill Training With Concurrently Controlled Speed and Cadence in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Training Group
Arm Type
Experimental
Arm Description
This arm will receive a single session treadmill training session in which both cadence and treadmill speed are controlled.
Arm Title
Traditional Training Group
Arm Type
Experimental
Arm Description
This arm will receive a single session treadmill training session in which only treadmill speed is controlled.
Intervention Type
Behavioral
Intervention Name(s)
Advanced treadmill walking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional treadmill walking
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline and post-intervention (about 1 hour following the baseline)
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline and post-intervention (about 1 hour following the baseline)
Title
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.
Description
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.
Time Frame
Baseline and post-intervention (about 1 hour following the baseline)
Title
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.
Description
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.
Time Frame
Baseline and post-intervention (about 1 hour following the baseline)
Title
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.
Description
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.
Time Frame
Baseline and post-intervention (about 1 hour following the baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Yang, PhD
Phone
404-413-8357
Email
fyang@gsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Ban, MS
Email
rban1@student.gsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Yang, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Yang, PhD
Phone
404-413-8357
Email
fyang@gsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Treadmill Training in People With Parkinson's Disease

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