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

NCT02438124 | Unknown DMC

• 1 other identifier: 9193-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Rhythmic auditory stimulation; Gait

Outcome Measures

Primary Outcomes (1)

• gait velocity

  evaluation of walking speed between the different conditions

  2 days

Secondary Outcomes (1)

• spatio-temporal gait characteristics

  2 days

Study Arms (2)

Patient

EXPERIMENTAL

Patient with Parkinson's Disease with walking test and neuropsychological evaluation

Behavioral: Neuropsychological evaluation

Contrôle

EXPERIMENTAL

normal control with walking test and neuropsychological evaluation

Behavioral: Neuropsychological evaluation

Interventions

Neuropsychological evaluation BEHAVIORAL

The subjects are submitted in one hearing stimulus while they realize a walking test

Contrôle; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or lactating woman
• high probability of non-compliance
• clinical signs of parkinsonian syndrome
• neurological disease
• gait disorder

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (3)

Service de neurologie de la Clinique Beau Soleil

Montpellier, 34070, France

RECRUITING

CIC

Montpellier, 34235, France

RECRUITING

Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du

Montpellier, 34235, France

RECRUITING

Related Publications (47)

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MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Valérie Cochen De Cock, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Cochen De Cock, MD

CONTACT

06 09 04 35 0; valerie.cochen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

FR (3)