Department of Neurological Rehabilitation, Shanghai Second Rehabilitation Hospital, No. 25, Lane 860, Changjiang Road, Baoshan District, Shanghai, 200441, China.
West China School of Public Health, Sichuan University, Chengdu, China.
Trials. 2021 May 10;22(1):335. doi: 10.1186/s13063-021-05258-w.
Progression of freezing of gait, a common pathological gait in Parkinson's disease, is an important risk factor for diagnosing the disease and has been shown to predispose patients to easy falls, loss of independent living ability, and reduced quality of life. Treating Parkinson's disease with freezing of gait is very difficult, while the use of medicine and operation has been ineffective. Music exercise therapy, which entails listening to music as you exercise, has been proposed as a treatment technology that can change patients' behavior, emotions, and physiological activity. In recent years, music exercise therapy has been widely used in treatment of motor disorders and neurological diseases and achieved remarkable results. Results from our earlier pilot study revealed that music exercise therapy can improve the freezing of gait of Parkinson's patients and improve their quality of life. Therefore, we aim to validate clinical efficacy of this therapy on freezing of gait of Parkinson's patients using a larger sample size.
METHODS/DESIGN: This three-arm randomized controlled trial will evaluate clinical efficacy of music exercise therapy in improving the freezing of gait in Parkinson's patients. We will recruit a total of 81 inpatients with Parkinson's disease, who meet the trial criteria. The patients will randomly receive music exercise with and without music as well as routine rehabilitation therapies, followed by analysis of changes in their gait and limb motor function after 4 weeks of intervention. We will first use a three-dimensional gait analysis system to evaluate changes in patients' gait, followed by assessment of their limb function, activity of daily living and fall risk.
The findings of this trial are expected to affirm the clinical application of this therapy for future management of the disease.
Chinese Clinical Trial Registry ChiCTR1900026063 . Registered on September 20, 2019.
冻结步态是帕金森病中一种常见的病理性步态，其进展是诊断该病的一个重要危险因素，并且易导致患者跌倒、丧失独立生活能力和降低生活质量。治疗冻结步态的帕金森病非常困难，而药物和手术治疗均未取得效果。音乐运动疗法，即在运动的同时听音乐，已被提出作为一种可以改变患者行为、情绪和生理活动的治疗技术。近年来，音乐运动疗法已广泛应用于运动障碍和神经疾病的治疗，并取得了显著成效。我们之前的初步研究结果表明，音乐运动疗法可以改善帕金森病患者的冻结步态并提高其生活质量。因此，我们旨在使用更大的样本量验证该疗法对帕金森病患者冻结步态的临床疗效。
方法/设计：这项三臂随机对照试验将评估音乐运动疗法改善帕金森病患者冻结步态的临床疗效。我们将总共招募 81 名符合试验标准的帕金森病住院患者。患者将随机接受音乐运动疗法（有音乐和无音乐）和常规康复治疗，然后分析干预 4 周后他们步态和肢体运动功能的变化。我们将首先使用三维步态分析系统评估患者步态的变化，然后评估他们的肢体功能、日常生活活动能力和跌倒风险。
这项试验的结果有望肯定该疗法在未来疾病管理中的临床应用。
中国临床试验注册中心 ChiCTR1900026063 。注册于 2019 年 9 月 20 日。
