NCT05585489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2021

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

14 days

First QC Date

October 12, 2022

Last Update Submit

October 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Step length

    Step length during confortable gait over 8 meters

    Before and just after the intervention (day 1)

Study Arms (1)

Persons with moderate idiopathic Parkinson's disease

EXPERIMENTAL
Other: Gait training with musical cue

Interventions

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.

Persons with moderate idiopathic Parkinson's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Idiopathic Parkinson's disease based on UKPDSBB criteria
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire Analyse et Restauration du Mouvement

Créteil, France

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicParkinson Disease

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research engineer

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 18, 2022

Study Start

June 22, 2021

Primary Completion

July 6, 2021

Study Completion

September 30, 2021

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations