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Autocorrelated Rhythmic Auditory Stimulations for Parkinson's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03716674
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Metronome Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of 9 patients completed the 4 conditions presented in the Methods section.
Masking: None (Open Label)
Masking Description: This was a cross-sectional study
Primary Purpose: Other
Official Title: Autocorrelated Rhythmic Auditory Stimulations as the Best Way to Use a Metronome for Parkinson's Disease Patients: a Prospective Cohort Study
Actual Study Start Date : February 2, 2015
Actual Primary Completion Date : February 19, 2015
Actual Study Completion Date : February 19, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Parkinson's Disease patients Device: Metronome
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.

Primary Outcome Measures :
  1. Long-Range Autocorrelations [ Time Frame: Change from baseline in long-range autocorrelations during each intervention condition (2 days, 2 x 10 min walking each day) ]

Secondary Outcome Measures :
  1. Mean gait speed [ Time Frame: Change from baseline in mean gait speed during each intervention condition (2 days, 2 x 10 min walking each day) ]
    Total walking distance (m)/ Acquisition duration (s)

  2. Step length [ Time Frame: Change from baseline in step length during each intervention condition (2 days, 2 x 10 min walking each day) ]
    Gait speed (m/s)*60/Gait cadence (steps/min)

  3. Gait cadence [ Time Frame: Change from baseline in gait cadence during each intervention condition (2 days, 2 x 10 min walking each day) ]
    Total number of steps (#)/Acquisition duration (min)

  4. Coefficient of variation of stride duration [ Time Frame: Change from baseline in coefficient of variation during each intervention condition (2 days, 2 x 10 min walking each day) ]
    [SD/mean stride duration] * 100

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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Responsible Party: Lejeune, Clinical Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier: NCT03716674    
Other Study ID Numbers: NMSK - Lheureux - 01
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Parkinson's Disease
rhythmic auditory stimulation
Long-Range Autocorrelations
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases