Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Behavioral: Neuropsychological evaluation

• Registration Number: NCT02438124
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08
• Primary Completion: 2016-03
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patient	Neuropsychological evaluation	Patient with Parkinson's Disease with walking test and neuropsychological evaluation
Contrôle	Neuropsychological evaluation	normal control with walking test and neuropsychological evaluation

Primary Outcome Measures

Name	Time	Method
gait velocity	2 days	evaluation of walking speed between the different conditions

Secondary Outcome Measures

Name	Time	Method
spatio-temporal gait characteristics	2 days	evaluation of other walking parameters between the different conditions

Trial Locations

Locations (3)

CIC; 🇫🇷 Montpellier, France

Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du; 🇫🇷 Montpellier, France

Service de neurologie de la Clinique Beau Soleil; 🇫🇷 Montpellier, France