NCT03716674

Brief Summary

Parkinson's Disease (PD) patients suffer from gait impairments responsible for falls and bad quality of life: reduced speed and stride length, randomness in stride duration variability (reduced Long-Range Autocorrelations (LRA)). Authors showed beneficial effects of isochronic Rhythmic Auditory Stimulation (RAS) on stride length and speed but a deleterious effect on LRA. The aim of this prospective cohort study was to compare between 3 different RAS (isochronic, random and autocorrelated) on 9 PD patients' gait parameters and stride duration variability. Although the autocorrelated RAS (AC) does not improve the LRA present in the stride duration variability, the AC does, however, maintain an acceptable level of LRA for PD patients' gait stability. The autocorrelated RAS would therefore possibly be the best way to apply auditory cueing to PD patients but this must be confirmed by future longitudinal studies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable parkinson-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

17 days

First QC Date

August 31, 2018

Last Update Submit

October 22, 2018

Conditions

Keywords

Parkinson's Diseaserhythmic auditory stimulationcueingLong-Range Autocorrelations

Outcome Measures

Primary Outcomes (1)

  • Long-Range Autocorrelations

    Change from baseline in long-range autocorrelations during each intervention condition (2 days, 2 x 10 min walking each day)

Secondary Outcomes (4)

  • Mean gait speed

    Change from baseline in mean gait speed during each intervention condition (2 days, 2 x 10 min walking each day)

  • Step length

    Change from baseline in step length during each intervention condition (2 days, 2 x 10 min walking each day)

  • Gait cadence

    Change from baseline in gait cadence during each intervention condition (2 days, 2 x 10 min walking each day)

  • Coefficient of variation of stride duration

    Change from baseline in coefficient of variation during each intervention condition (2 days, 2 x 10 min walking each day)

Study Arms (1)

Parkinson's Disease patients

EXPERIMENTAL
Device: Metronome

Interventions

MetronomeDEVICE

Patients completed 4 walking sessions of at least 10 minutes each. During each session, no auditory rhythm was given, or the rhythm of a Rhythmic Auditory Stimulation (RAS) adapted to the pace of comfort of each patient using a metronome was broadcasted via headphones. In all, 4 conditions were tested: walk with no RAS or an isochronous RAS or a random RAS or a RAS with an autocorrelated metronome rhythm.

Parkinson's Disease patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's Disease according to UK Brain Bank criteria
  • A modified Hoehn \& Yahr scale between 1 and 3
  • Able to walk for at least 10 minutes in a row
  • Dopaminergic was stable for a minimum of 4 weeks before the study starts
  • A Mini-Mental State Examination (MMSE) \>24

You may not qualify if:

  • Severe co-morbidity, other neurological problems, acute medical problems (e.g. MI, diabetes) and joint problems affecting mobility
  • Unpredictable "Off"-periods (score \>2, MDS-UPDRS item 4.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This was a cross-sectional study
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A single group of 9 patients completed the 4 conditions presented in the Methods section.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 31, 2018

First Posted

October 23, 2018

Study Start

February 2, 2015

Primary Completion

February 19, 2015

Study Completion

February 19, 2015

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share