Clinical trial NCT05239026: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Baseline and post-intervention (about 1 hour following the baseline)
Secondary outcomes:
measure: 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.
timeFrame: Baseline and post-intervention (about 1 hour following the baseline)
measure: 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.
timeFrame: Baseline and post-intervention (about 1 hour following the baseline)
measure: 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.
timeFrame: Baseline and post-intervention (about 1 hour following the baseline)
measure: 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.
timeFrame: Baseline and post-intervention (about 1 hour following the baseline)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Feng Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: