Parkinson Disease Clinical Trial
— BeatParkOfficial title:
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
Physical activity has beneficial effects on the quality of walking for persons with Parkinson's disease (PD). However, regular physical activity is still limited in most patients' daily lives. The rhythm of music makes you want to move whether you are sick or not. In addition, it has been found that in people with PD, it can also improve walking by helping the participant to regain the regularity of alternating steps and a better walking dynamic (i.e. better position, better arm swinging, etc.). Studies have shown that music allows persons with PD to walk faster, with bigger steps. However, if the tempo of the music does not correspond to the participant's walking pace, instead of helping him, it can disturb him. So it seems necessary for music to help people with PD to walk better if the tempo of the music is set to match their steps. BeatPark is a smartphone application which makes it possible to synchronize the tempo of the music with the participant's walking rhythm detected thanks to feet insoles. Once synchronized to the participant's walking pace, BeatPark imperceptibly accelerates the tempo of the music to help the participant's acceleration. This clinical trial proposes to study the effects of walking rehabilitation depending on the use of music synchronized to the participant's step with BeatPark, music with random tempo or without music.
Status | Recruiting |
Enrollment | 396 |
Est. completion date | December 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 36 Years to 94 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Clinique Beau Soleil | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
Clinique Beau Soleil | AxLR SATT, Euromov, Montpellier Univeristy, Team Languedoc Mutualité / Nouvelles technologies, Université de Montréal, University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in average speeds | The main outcome measure is the difference in average speeds measured during walking with musical stimulation during the last 10 minutes of the last 3 self-rehabilitation sessions.
These speeds will be measured by the "Feetme(c)" soles under the same conditions ecological. If the subject stops his program before having completed the 20 full sessions, the speed will be evaluated over the last 3 fully completed rehabilitation sessions. Statistical analysis will be done with intent to treat. This criterion will be applied in main judgment to compare groups with music adapted and music at random tempo. |
Up to 6 weeks |
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