Parkinson DiseaseNCT03253965
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
A study testing Metronome Normal, Metronome Slow and Metronome Fast in people with Parkinson Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to determine how using auditory cues of a metronome and music at various frequencies impacts the gait mechanics in people with Parkinson's disease when walking over ground and on a treadmill. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Metronome Normal, Metronome Slow and Metronome Fast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 1 Aug 2018
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk >10 m overground as well as walk on a treadmill for a total of 14 minutes with rest breaks as needed, and be classified as Stage 1, 2, or 3 on the Hoehn and Yahr Scale since these stages have the most independence with mobility (Goetz et. al, 2004).
Who cannot join
- Exclusion criteria include Hoehn and Yahr Stage 4 and 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The purpose of this study is to determine how using auditory cues of a metronome and music at various frequencies impacts the gait mechanics in people with Parkinson's disease when walking over ground and on a treadmill.
The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired subjects.
Participants will complete 7 different treadmill walking conditions and overground walking conditions while the investigators measure step length, cadence, gait speed, and variability of movement.
- Conditions
- Parkinson Disease
- Being tested
- Metronome Normal, Metronome Slow, Metronome Fast, Music Normal, Music Slow
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronome NormalOther
Steps are timed with the beat of the metronome set to the subject's cadence
Metronome SlowOther
Steps are timed with the beat of the metronome set to 85% of the subject's cadence
Metronome FastOther
Steps are timed with the beat of the metronome set to 115% of the subject's cadence
Music NormalOther
Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence
Music SlowOther
Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence
Music FastOther
Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence
No Auditory cueingOther
Steps are not timed with any auditory cue.
| Study group | Role | What they receive |
|---|---|---|
| Walking: Treadmill then Overground | Experimental | Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing. Receives: Other: Metronome Normal; Other: Metronome Slow; Other: Metronome Fast; Other: Music Normal; Other: Music Slow; Other: Music Fast; Other: No Auditory cueing |
| Walking: Overground, then Treadmill | Experimental | Walking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing. Receives: Other: Metronome Normal; Other: Metronome Slow; Other: Metronome Fast; Other: Music Normal; Other: Music Slow; Other: Music Fast; Other: No Auditory cueing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length
The length of each step taken while walking on a treadmill or overground. It is the anteroposterior distance from one foot to the other at heel strike measured during walking under each condition.
Measured: The entire duration of each condition, approximately 2 minutes each.
Secondary outcomes (3)
Cadence
The number of steps taken per minute measured while walking on a treadmill or overground under each condition.
Measured: The entire duration of each condition, approximately 2 minutes each.
Gait speed
The distance covered in a measured period of time (meters per second) while walking overground under each condition.
Measured: The entire duration of each condition, approximately 2 minutes each.
Movement variability
The coefficient of variation of spatiotemporal measures (step timing and step length) while walking overground and on a treadmill under each condition.
Measured: The entire duration of each condition, approximately 2 minutes each.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start15 Sep 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guneet Chawla, Principal investigator, University of North Carolina, Chapel HillMichael Lewek, PT, PhD, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253965
- Sponsor's protocol ID
- 17-2089
- Status last verified
- Nov 2018
- First submitted
- 11 Aug 2017
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03253965
- Acronym / sponsor ID
- 17-2089
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 18 Aug 2017 (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 purpose of this study is to determine how using auditory cues of a metronome and music at various frequencies impacts the gait mechanics in people with Parkinson's disease when walking over ground and on a treadmill.
The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired subjects.
Participants will complete 7 different treadmill walking conditions and overground walking conditions while the investigators measure step length, cadence, gait speed, and variability of movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking: Treadmill then Overground | Experimental | Other: Metronome Normal, Other: Metronome Slow, Other: Metronome Fast, Other: Music Normal, Other: Music Slow, Other: Music Fast, Other: No Auditory cueingWalking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing. |
| Walking: Overground, then Treadmill | Experimental | Other: Metronome Normal, Other: Metronome Slow, Other: Metronome Fast, Other: Music Normal, Other: Music Slow, Other: Music Fast, Other: No Auditory cueingWalking while receiving auditory cueing intervals from a metronome and music. Testing performed using metronome normal, metronome slow, and metronome fast speed settings as well as music normal, music slow, and music fast tempos. Subjects will also walk with no auditory cueing. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a diagnosis of Parkinson's Disease (made by movement disorders specialist) will be included in this study. Additional inclusion criteria include: self-reported ability to walk >10 m overground as well as walk on a treadmill for a total of 14 minutes with rest breaks as needed, and be classified as Stage 1, 2, or 3 on the Hoehn and Yahr Scale since these stages have the most independence with mobility (Goetz et. al, 2004).
Key exclusion criteria (1 listed)
- Exclusion criteria include Hoehn and Yahr Stage 4 and 5, uncontrolled cardiorespiratory/metabolic disease (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, orthostatic hypertension, chronic emphysema), or other neurological or orthopedic disorders that may affect walking. The investigators will also exclude participants with severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures.
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 |
|---|---|---|
| Metronome NormalSteps are timed with the beat of the metronome set to the subject's cadence | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
| Metronome SlowSteps are timed with the beat of the metronome set to 85% of the subject's cadence | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
| Metronome FastSteps are timed with the beat of the metronome set to 115% of the subject's cadence | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
| Music NormalSteps are timed with the beat of the music by a rhythm consistent with the subject's cadence | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
| Music SlowSteps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
| Music FastSteps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
| No Auditory cueingSteps are not timed with any auditory cue. | Other | Walking: Overground, then Treadmill, Walking: Treadmill then Overground |
Primary outcome
Step Length
Time frame: The entire duration of each condition, approximately 2 minutes each.
The length of each step taken while walking on a treadmill or overground. It is the anteroposterior distance from one foot to the other at heel strike measured during walking under each condition.
3 secondary outcomes
Cadence
Time frame: The entire duration of each condition, approximately 2 minutes each.
Gait speed
Time frame: The entire duration of each condition, approximately 2 minutes each.
Movement variability
Time frame: The entire duration of each condition, approximately 2 minutes each.
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 13 Nov 2018.
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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.
Guneet Chawla principal investigator
University of North Carolina, Chapel Hill
Michael Lewek, PT, PhD study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronome Normal, Metronome Slow and Metronome Fast in people with Parkinson Disease, run by University of North Carolina, Chapel Hill 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 1 inclusion and 1 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 13 Nov 2018. 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?
Step Length (time frame: The entire duration of each condition, approximately 2 minutes each.). 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 13 Nov 2018.