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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological evaluation
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's disease, Rhythmic auditory stimulation, Gait

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Service de neurologie de la Clinique Beau SoleilRecruiting
  • CICRecruiting
  • Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) duRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Contrôle

Arm Description

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

normal control with walking test and neuropsychological evaluation

Outcomes

Primary Outcome Measures

gait velocity
evaluation of walking speed between the different conditions

Secondary Outcome Measures

spatio-temporal gait characteristics
evaluation of other walking parameters between the different conditions

Full Information

First Posted
April 30, 2015
Last Updated
January 7, 2016
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02438124
Brief Title
Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study
Acronym
BeatPark
Official Title
Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Rhythmic auditory stimulation, Gait

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
Patient with Parkinson's Disease with walking test and neuropsychological evaluation
Arm Title
Contrôle
Arm Type
Experimental
Arm Description
normal control with walking test and neuropsychological evaluation
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological evaluation
Intervention Description
The subjects are submitted in one hearing stimulus while they realize a walking test
Primary Outcome Measure Information:
Title
gait velocity
Description
evaluation of walking speed between the different conditions
Time Frame
2 days
Secondary Outcome Measure Information:
Title
spatio-temporal gait characteristics
Description
evaluation of other walking parameters between the different conditions
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Cochen De Cock, MD
Phone
06 09 04 35 0
Email
valerie.cochen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Cochen De Cock, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de neurologie de la Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cochen De Cock Valérie, MD
Phone
06 09 04 35 05
Email
valerie.cochen@gmail.com
Facility Name
CIC
City
Montpellier
ZIP/Postal Code
34235
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Galtier, Doctor
First Name & Middle Initial & Last Name & Degree
Valérie Cochen De Cock, MD
Phone
06 09 04 35 05
Email
valerie.cochen@gmail.com
Facility Name
Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du
City
Montpellier
ZIP/Postal Code
34235
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Cochen de cock, MD
Phone
06 09 04 35 05
Email
valerie.cochen@gmail.com
First Name & Middle Initial & Last Name & Degree
Sophie Bayard

12. IPD Sharing Statement

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

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