Clinical trial NCT02438124: Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study
Official title: Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Rhythmic auditory stimulation
Gait
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
First posted: 2015-05-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* pregnant or lactating woman
* high probability of non-compliance
* curators , authorship or advisers to person of full age Specific exclusion criteria for PD patients
* clinical signs of parkinsonian syndrome
* Mini Mental State Examination \< 24/30 Specific exclusion criteria for controls
* neurological disease
* gait disorder

Primary outcomes:
measure: gait velocity
timeFrame: 2 days
Secondary outcomes:
measure: spatio-temporal gait characteristics
timeFrame: 2 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Service de neurologie de la Clinique Beau Soleil
city: Montpellier
country: France
facility: CIC
city: Montpellier
country: France
facility: Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du
Study officials:
affiliation: University Hospital, Montpellier
name: Valérie Cochen De Cock, MD
role: PRINCIPAL_INVESTIGATOR
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