Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study
NCT ID: NCT02438124
Last Updated: 2016-01-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-09-30
Study Completion Date
2016-09-30
Brief Summary
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The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research.
Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.
Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:
* RAS complexity (i.e. metronome, amplitude modulated noise, music)
* RAS variability (i.e fixed, random, semi-random)
* RAS adapted in real-time to gait
Variability study:
To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.
Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:
* RAS complexity (i.e. metronome, amplitude modulated noise, music)
* RAS variability (i.e fixed, random, semi-random)
* RAS adapted in real-time to gait
Variability study:
To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.
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Detailed Description
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Conditions
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Parkinson's Disease
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Patient
Patient with Parkinson's Disease with walking test and neuropsychological evaluation
Group Type
EXPERIMENTAL
Neuropsychological evaluation
Intervention Type
BEHAVIORAL
The subjects are submitted in one hearing stimulus while they realize a walking test
Contrôle
normal control with walking test and neuropsychological evaluation
Group Type
EXPERIMENTAL
Neuropsychological evaluation
Intervention Type
BEHAVIORAL
The subjects are submitted in one hearing stimulus while they realize a walking test
Interventions
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Neuropsychological evaluation
The subjects are submitted in one hearing stimulus while they realize a walking test
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* 18 y.o.
* to be able to understand the study aims and to agree to participate
* to have signed the consent form
* to be registered to social security system
* to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank)
* gait disorder clinically observable
* to be able to understand the study aims and to agree to participate
* to have signed the consent form
* to be registered to social security system
* to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank)
* gait disorder clinically observable
Exclusion Criteria
* pregnant or lactating woman
* high probability of non-compliance
* clinical signs of parkinsonian syndrome
* neurological disease
* gait disorder
* high probability of non-compliance
* clinical signs of parkinsonian syndrome
* neurological disease
* gait disorder
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Université Montpellier
OTHER
Sponsor Role
collaborator
University Hospital, Montpellier
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Valérie Cochen De Cock, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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Service de neurologie de la Clinique Beau Soleil
Montpellier, , France
Site Status
RECRUITING
CIC
Montpellier, , France
Site Status
RECRUITING
Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du
Montpellier, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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Florence Galtier, Doctor
Role: primary
Sophie Bayard
Role: backup
References
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Arias P, Cudeiro J. Effects of rhythmic sensory stimulation (auditory, visual) on gait in Parkinson's disease patients. Exp Brain Res. 2008 Apr;186(4):589-601. doi: 10.1007/s00221-007-1263-y. Epub 2008 Jan 23.
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RESULT
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Other Identifiers
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9193-2
Identifier Type: -
Identifier Source: org_study_id
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