Parkinson DiseaseBeatParkNCT04543058
BeatPark: Self-rehabilitation in Walking With Parkinson's Disease
A study testing BeatPark Application, BeatPark Application without synchronized music and BeatPark Application without music in people with Parkinson Disease and Walking, Difficulty, run by Clinique Beau Soleil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 94 years
- Conditions the study is for
- Parkinson Disease, Walking, Difficulty
- What is being tested?
- BeatPark Application, BeatPark Application without synchronized music and BeatPark Application without music
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 33Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Beau Soleil
Montpellier, Hérault, 34070
Valérie Cochen De Cock, M.D., 0033467789847, valerie.cochen@gmail.com
Valérie Cochen De Cock, M.D.
About this study
Official 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.
Read more
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.
Read the detailed description
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
- 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
- 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)
- 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.
- 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):
- 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.
- Conditions
- Parkinson Disease, Walking, Difficulty
- Being tested
- BeatPark Application, BeatPark Application without synchronized music, BeatPark Application without music
- Keywords
- Walking rehabilitation, Parkinson Disease, Music
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeatPark ApplicationDevice
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 Application without synchronized musicOther
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 musicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: BeatPark Application without music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Sep 2020
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Beau Soleil
- Sponsor type
- University, hospital or other
- Collaborators
- Team Languedoc Mutualité / Nouvelles technologies, University Hospital, Montpellier, Euromov, Montpellier Univeristy, Université de Montréal, AxLR SATT
- Responsible party
- Sponsor
- Investigators
- Valérie Cohen, M.D., Principal investigator, Clinique Beau Soleil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543058
- Sponsor's protocol ID
- 2019-A02032-55
- Acronym
- BeatPark
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04543058
- Acronym / sponsor ID
- BeatPark / 2019-A02032-55
- Conditions
- Parkinson Disease, Walking, Difficulty
- Keywords
- Walking rehabilitation, Parkinson Disease, Music
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Clinique Beau SoleilUniversity, hospital or other
- Collaborators
- Team Languedoc Mutualité / Nouvelles technologies, University Hospital, Montpellier, Euromov, Montpellier Univeristy, Université de Montréal, AxLR SATT
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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)
- 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.
- 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):
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BeatPark Experimental Group | Experimental | Device: BeatPark ApplicationGroup 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 | Other: BeatPark Application without synchronized musicGroup 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 | Other: BeatPark Application without musicGroup of participants who will make its self-rehabilitation in walking program using an application without music. |
Who may qualify
- Ages
- 36 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeatPark ApplicationThe 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. | Device | BeatPark Experimental Group |
| BeatPark Application without synchronized musicThe 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. | Other | Control Group with Music at Random Tempo |
| BeatPark Application without musicThe 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. | Other | Control Group without Music |
Primary outcome
Difference in average speeds
Time frame: Up to 6 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Cohen, M.D. principal investigator
Clinique Beau Soleil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeatPark Application, BeatPark Application without synchronized music and BeatPark Application without music in people with Parkinson Disease and Walking, Difficulty, run by Clinique Beau Soleil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Benard-Serre (0033499236915, n.benard@languedoc-mutualite.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in average speeds (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.