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Individualization of Music-based Cueing During Gait in Parkinson's Disease. (MUSIGAIT)

Primary Purpose

Gait Disorders, Neurologic, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gait training with musical cue
Sponsored by
Henri Mondor University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disorders, Neurologic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Idiopathic Parkinson's disease based on UKPDSBB criteria
  • 10-meter walking comfortable speed between 0,30 and 1,10 m/s
  • Capacities to walk with shoes during at least 20 minutes without assistance
  • Signature of informed consent

Exclusion Criteria:

  • Non-affiliation to Social Security
  • Person under protection (e.g. under protection of justice)
  • Auditory disorders without treatment
  • Cognitive disorders that limit the understanding of the study according to the medical investigator
  • Other neurological or orthoêdic disorders that addect walking
  • Participating in another Category 1 or 2 interventional clinical study for the duration of the trial

Sites / Locations

  • Laboratoire Analyse et Restauration du Mouvement

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Persons with moderate idiopathic Parkinson's disease

Arm Description

Outcomes

Primary Outcome Measures

Step length
Step length during confortable gait over 8 meters

Secondary Outcome Measures

Full Information

First Posted
October 12, 2022
Last Updated
October 2, 2023
Sponsor
Henri Mondor University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05585489
Brief Title
Individualization of Music-based Cueing During Gait in Parkinson's Disease.
Acronym
MUSIGAIT
Official Title
Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henri Mondor University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. An auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. The cue is integrated into music and is presented in an open-loop approach. The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Persons with moderate idiopathic Parkinson's disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Gait training with musical cue
Intervention Description
Entraînement de 20 minutes de marche à vitesse confortable sur un parcours ovale de 20 mètres au laboratoire ARM avec la technique d'indiçage musical personnalisé de la longueur de pas.
Primary Outcome Measure Information:
Title
Step length
Description
Step length during confortable gait over 8 meters
Time Frame
Before and just after the intervention (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Idiopathic Parkinson's disease based on UKPDSBB criteria 10-meter walking comfortable speed between 0,30 and 1,10 m/s Capacities to walk with shoes during at least 20 minutes without assistance Signature of informed consent Exclusion Criteria: Non-affiliation to Social Security Person under protection (e.g. under protection of justice) Auditory disorders without treatment Cognitive disorders that limit the understanding of the study according to the medical investigator Other neurological or orthoêdic disorders that addect walking Participating in another Category 1 or 2 interventional clinical study for the duration of the trial
Facility Information:
Facility Name
Laboratoire Analyse et Restauration du Mouvement
City
Créteil
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Individualization of Music-based Cueing During Gait in Parkinson's Disease.

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