Parkinson DiseaseNCT05239026
Treadmill Training in People With Parkinson's Disease
A study testing Advanced treadmill walking and Traditional treadmill walking in people with Parkinson Disease, run by Georgia State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Advanced treadmill walking and Traditional treadmill walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 9 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Advanced treadmill walking, Traditional treadmill walking
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced treadmill walkingBehavioural
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 walkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Training Group | Experimental | This arm will receive a single session treadmill training session in which both cadence and treadmill speed are controlled. Receives: Behavioral: Advanced treadmill walking |
| Traditional Training Group | Experimental | This arm will receive a single session treadmill training session in which only treadmill speed is controlled. Receives: Behavioral: Traditional treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention (about 1 hour following the baseline)
Secondary outcomes (4)
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.
Measured: Baseline and post-intervention (about 1 hour following the baseline)
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.
Measured: Baseline and post-intervention (about 1 hour following the baseline)
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.
Measured: Baseline and post-intervention (about 1 hour following the baseline)
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.
Measured: Baseline and post-intervention (about 1 hour following the baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start21 Mar 2022
- Primary completion31 May 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Yang, PhD, Georgia State University
- Investigators
- Feng Yang, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239026
- Sponsor's protocol ID
- H22192
- Status last verified
- Jul 2024
- First submitted
- 6 Jan 2022
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Training With Concurrently Controlled Speed and Cadence in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05239026
- Acronym / sponsor ID
- H22192
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced Training Group | Experimental | Behavioral: Advanced treadmill walkingThis arm will receive a single session treadmill training session in which both cadence and treadmill speed are controlled. |
| Traditional Training Group | Experimental | Behavioral: Traditional treadmill walkingThis arm will receive a single session treadmill training session in which only treadmill speed is controlled. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced treadmill walkingParticipants 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. | Behavioural | Advanced Training Group |
| Traditional treadmill walkingParticipants 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. | Behavioural | Traditional Training Group |
Primary outcome
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.
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Yang, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced treadmill walking and Traditional treadmill walking in people with Parkinson Disease, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline and post-intervention (about 1 hour following the baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.