Self-rehabilitation for walking in Parkinson's disease using music

Randomized Controlled Study of the Effectiveness of a Self-education Program When Walking by Rhythmic Auditory Stimulation Adapted Music, Delivered by BeatPark, in People With Parkinson's Disease

This study is testing if a smartphone app that uses music can help people with Parkinson's disease walk better and feel more motivated.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 396 (estimated)
• Ages: 36 Years to 94 Years
• Sex: All
• Sponsor: Clinique Beau Soleil (Academic / other)
• Locations: 1 site (Montpellier, Hérault)
• Trial ID: NCT04543058 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the BeatPark smartphone application, which synchronizes music tempo with the walking rhythm of individuals with Parkinson's disease (PD). Participants will be divided into groups that either use the application with music, without music, or without synchronization. The study aims to assess improvements in walking dynamics, including step regularity and speed, through a series of visits that include neurological examinations and self-assessments. Data will be collected on falls, freezing episodes, and overall motivation during the intervention period.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson's disease who experience walking difficulties but can walk independently for at least 30 minutes.

Not a fit: Patients with atypical parkinsonian syndromes or those requiring assistance to walk will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance walking ability and quality of life for patients with Parkinson's disease.

How similar studies have performed: Previous studies have shown promising results using music to improve walking in Parkinson's patients, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

Specific Inclusion Criteria:

* Have a diagnosis of idiopathic PD according to the MDS clinical Diagnostic Criteria for PD (Postuma et al. 2015);
* Have a walking disorder defined by the neurologist (Item 10 of the MDSUPDRS-III ≥1);
* Be able to walk 30 consecutive minutes without technical assistance (e.g. cane or walker) or human assistance;
* Receive an uninterrupted antiparkinsonian pharmacological treatment since one month (and throughout the study period).

Non-Specific Inclusion Criteria:

* Be over 35 and under 95 of age;
* Be able to understand the nature, purpose and methodology of the study and agree to cooperate during assessments;
* Have signed the informed consent;
* Be affiliated to a social security plan or affiliated to such a equivalent health plan.

Non-Inclusions:

Specific Non-Inclusion Criteria:

* Presence of signs in favor of an atypical parkinsonian syndrome (involvement oculomotor, early falls, hallucinations, Montreal Cognitive Assessment \<21/30, severe and early dysautonomia);
* Have a hearing impairment;
* Have any other neurological damage that affects walking;
* Have a walking disorder of other origin (e.g. orthopedic, rheumatological, etc.);
* Have severe or unbalanced heart or respiratory Failure which contraindicates walk rehabilitation.

Non-Specific Non-Inclusion Criteria:

* Adult under legal protection or unfit to express their consent (Article 1121-8 of the CSP);
* Vulnerable people (Article L 1121-6 of the CSP);
* Loss of liberty by judicial or administrative decision;
* High probability of non-compliance with the protocol or abandonment during the study;
* Pregnant / lactating women.

Non-Inclusion Criteria for the subgroup that will carry out the MRI ancillary study:

* Pacemaker or neurosensory stimulator or implantable defibrillator;
* Cochlear implants;
* Foreign ferromagnetic ocular or cerebral bodies close to nervous structures
* Metal prosthesis;
* Agitation of the participants: non-cooperative or agitated participants;
* Claustrophobic participants;
* Pregnant woman;
* Ventriculo-peritoneal neurosurgical bypass valves;
* Braces.

Exclusion Criteria:

* Participant no longer wishing to participate in the study, or during the study with refusal to use data until the time of the study exit;
* A change in the background treatment of PD will not systematically justify leaving the study but will be evaluated by the scientific committee on a case-by-case basis.

Where this trial is running

Montpellier, Hérault

• Clinique Beau Soleil — Montpellier, Hérault, France (Recruiting)

Study contacts

• Principal investigator: Valérie Cohen, M.D. — Clinique Beau Soleil
• Study coordinator: Nicolas Benard-Serre

Conditions Parkinson Disease; Walking, Difficulty; Walking rehabilitation; Music