Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT04543058
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.
Detailed Description:
Groups, with and without music, will have the same visits and the same instructions throughout the study.
1. Visit 0 (inclusion visit)
* Verification of inclusion and non-inclusion criteria
* Signature of consent
* Information gathering
* Demographic information (date of birth, height, weight, activity, etc.) professional).
* Clinical information about the disease (age of onset and duration of the disease, treatments and their distribution).
* Medical history including present or past medical conditions and any other conditions that may be relevant to the study and their treatment.
* 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
2. 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.
3. Visit 1 (week 2)
* Run the 6 minutes test in silence.
* Actualization of the Battery for the Assessment of Auditory Sensorimotor and Timing Abilities (BAASTA).
* Collecting and checking the completeness of the different scales given at visit 0 and helping to fill in incomplete scales.
* Information and training in the use of the BeatPark device (programmed with or without music according to randomization)
* Explanation of the self-education program (number of sessions, duration, location...) for the 4 weeks.
* Delivery of questionnaires to be completed within 3 days prior to the visit 2.
* MRI: morphological sequences (T1 3D, T2 FLAIR, T2\*) and functional sequences (Resting state and with the different types of auditory indication) for the subgroup explored in imaging.
4. 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.
5. Visit 2 (end-of-study visit, week 4):
* Neurological evaluation with the MDS-UPDRS, NFOG and CGI (Clinical Global Impression) scales.
* Running the 6 minutes test in silence
* Achievement of the BAASTA
* Collection and verification of the completeness of the different scales submitted to V1 (and completed within the last 3 days) and helps to fill in incomplete scales
* Checking for no change in anti-parkinsonian treatment.
* Return the equipment to the investigation team.
* MRI: morphological sequences (T1 3D, T2 FLAIR, T2\*) and functional sequences (Resting, T2 FLAIR, T2\*). state and with the different types of auditory indication))) for the subgroup explored in imagery.
Study:
NCT04543058
Study Brief:
Protocol Section:
NCT04543058