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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- Difference in average speeds
研究概览
简要总结
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.
详细描述
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
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Demographic information (date of birth, height, weight, activity, etc.) professional).
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Clinical information about the disease (age of onset and duration of the disease, treatments and their distribution).
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Medical history including present or past medical conditions and any other conditions that may be relevant to the study and their treatment.
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Neurological examination with MDS-UPDRS (Movement Disorder Society - Unified Parkinson's Disease Rating Scale) and NFOG-Q (New Freezing of Gait-Questionnaire) scales
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Explanation and delivery of the agenda for the next 2 weeks
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"Feetme(c)" soles in place
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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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 36 Years 至 94 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
结局指标
主要结局
Difference in average speeds
时间窗: 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.
次要结局
未报告次要终点