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

January 7, 2016 updated by: University Hospital, Montpellier

Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34070
        • Recruiting
        • Service de neurologie de la Clinique Beau Soleil
        • Contact:
      • Montpellier, France, 34235
        • Recruiting
        • CIC
        • Contact:
          • Florence Galtier, Doctor
        • Contact:
      • Montpellier, France, 34235
        • Recruiting
        • Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du
        • Contact:
        • Contact:
          • Sophie Bayard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient
Patient with Parkinson's Disease with walking test and neuropsychological evaluation
Behavioral: Neuropsychological evaluation
The subjects are submitted in one hearing stimulus while they realize a walking test
Experimental: Contrôle
normal control with walking test and neuropsychological evaluation
Behavioral: Neuropsychological evaluation
The subjects are submitted in one hearing stimulus while they realize a walking test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait velocity
Time Frame: 2 days
evaluation of walking speed between the different conditions
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spatio-temporal gait characteristics
Time Frame: 2 days
evaluation of other walking parameters between the different conditions
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Université Montpellier

Investigators

  • Principal Investigator: Valérie Cochen De Cock, MD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9193-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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