BeatPark: Self-rehabilitation in Walking With Parkinson's Disease

NCT04543058 | Unknown DMC

• 1 other identifier: 2019-A02032-55
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Walking, Difficulty

Keywords

Walking rehabilitation; Parkinson Disease; Music

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

BeatPark Experimental Group

EXPERIMENTAL

Group of participants who will make its self-rehabilitation in walking program using BeatPark application, delivering synchronized music adapted to the patient walking progression.

Device: BeatPark Application

Control Group with Music at Random Tempo

ACTIVE COMPARATOR

Group of participants who will make its self-rehabilitation in walking program using an application delivering music at random tempo.

Other: BeatPark Application without synchronized music

Control Group without Music

ACTIVE COMPARATOR

Group of participants who will make its self-rehabilitation in walking program using an application without music.

Other: BeatPark Application without music

Interventions

BeatPark Application DEVICE

The participant walks for 30 minutes a day, 5 day a week for 4 weeks. During the walking session, BeatPark Application delivers synchronized music adapted to the patient walking. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.

BeatPark Experimental Group

BeatPark Application without synchronized music OTHER

The participant walks for 30 minutes a day, 5 days a week for 4 weeks. During the walking session, BeatPark Application delivers random music at random tempo. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.

Control Group with Music at Random Tempo

BeatPark Application without music OTHER

The participant walks for 30 minutes a day, 5 days a week for 4 weeks. During the walking session, BeatPark Application does not deliver music. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.

Control Group without Music

Eligibility Criteria

• Age: 36 Years - 94 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.
• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Beau Soleil: lead
• Team Languedoc Mutualité / Nouvelles technologies: collaborator
• University Hospital, Montpellier: collaborator
• Euromov, Montpellier Univeristy: collaborator
• Université de Montréal: collaborator
• AxLR SATT: collaborator

Study Sites (1)

Clinique Beau Soleil

Montpellier, Hérault, 34070, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie Cohen, M.D.

  Clinique Beau Soleil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Benard-Serre

CONTACT

0033499236915; n.benard@languedoc-mutualite.fr

Sandy Lacombe

CONTACT

0033467459397; s.lacombe@languedoc-mutualite.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: September 9, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2023-08

Locations

FR (1)