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| Name | Class |
|---|---|
| Team Languedoc Mutualité / Nouvelles technologies | UNKNOWN |
| University Hospital, Montpellier | OTHER |
| Euromov, Montpellier Univeristy | UNKNOWN |
| Université de Montréal |
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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.
Groups, with and without music, will have the same visits and the same instructions throughout the study.
Visit 0 (inclusion visit)
Verification of inclusion and non-inclusion criteria
Signature of consent
Information gathering
Neurological examination with MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) and NFOG-Q (New Freezing of Gait-Questionnaire) scales
Explanation and delivery of the agenda for the next 2 weeks
"Feetme(c)" soles in place
Remittance of self-questionnaires for a home refill before V1
Base Line From the day of inclusion until visit 1 the patient will complete a diary to record the occurrence of falls and freezing, and to self-assess on a visual numerical scale their levels of pain, fatigue and motivation.
Visit 1 (week 2)
Intervention phase
*Self-reeducation program:
This program will consist of walking outdoors for 5 sessions of 30 minutes per week for 4 consecutive weeks with the BeatPark device (set to deliver music or not, adapted music or random tempo).
* Phone call:
The clinical research associate (CRA) will contact the patient to ensure the proper functioning and compliance with the rehabilitation program, if any difficulties are encountered.
*Self-assessment schedule:
From the day of visit 1 through visit 2 the participant will complete a diary to record the occurrence of falls and freezing, and to self-assess on a visual numerical scale their levels of pain, fatigue, motivation and satisfaction.
Visit 2 (end-of-study visit, week 4):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Control Group without Music | Active Comparator | Group of participants who will make its self-rehabilitation in walking program using an application without music. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Specific Inclusion Criteria:
Non-Specific Inclusion Criteria:
Non-Inclusions:
Specific Non-Inclusion Criteria:
Non-Specific Non-Inclusion Criteria:
Non-Inclusion Criteria for the subgroup that will carry out the MRI ancillary study:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Benard-Serre | Contact | 0033499236915 | n.benard@languedoc-mutualite.fr | |
| Sandy Lacombe | Contact | 0033467459397 | s.lacombe@languedoc-mutualite.fr |
| Name | Affiliation | Role |
|---|---|---|
| Valérie Cohen, M.D. | Clinique Beau Soleil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Beau Soleil | Recruiting | Montpellier | Hérault | 34070 | France |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
| AxLR SATT | UNKNOWN |
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|
| 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. |
|
| 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. |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |