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Gait Disorders, NeurologicMUSIGAITNCT05585489

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

A study testing Gait training with musical cue in people with Gait Disorders, Neurologic and Parkinson Disease, run by Henri Mondor University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gait Disorders, Neurologic, Parkinson Disease
What is being tested?
Gait training with musical cue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteFrance
Study dates
22 Jun 2021to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Laboratoire Analyse et Restauration du Mouvement

    Créteil

Other trials in France

About this study

Official title: Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial

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.

Being tested
Gait training with musical cue
Medical subject headings
Gait Disorders, Neurologic, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait training with musical cueOther

    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.

Study groups in NCT05585489
Study groupRoleWhat they receive
Persons with moderate idiopathic Parkinson's diseaseExperimentalNot described
Receives: Other: Gait training with musical cue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Step length

    Step length during confortable gait over 8 meters

    Measured: Before and just after the intervention (day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start22 Jun 2021
  3. Primary completion6 Jul 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585489
Sponsor's protocol ID
2021-A00959-32
Acronym
MUSIGAIT
Status last verified
Oct 2023
First submitted
12 Oct 2022
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gait training with musical cue in people with Gait Disorders, Neurologic and Parkinson Disease, run by Henri Mondor University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step length (time frame: Before and just after the intervention (day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.

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