Feasibility Study of the Taïso Practice in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of traumatic incident(s) and/or cardiovascular(s)
研究概览
简要总结
This is a pilot study of descriptive and analytical, prospective feasibility, monocentric, longitudinal with 6 months of bi-weekly practice of Taïso in patients with Parkinson's disease with mild to moderate postural instability.
The intervention is planned over 6 months (25 consecutive weeks) for the whole project of the patient group. Patients are included in the month before the start of the treatment of the intervention. Four standardized evaluation sessions are conducted: a first evaluation during the first week of Taiso and then every 8 weeks (2 months, 4 months and 6 months). Incident collection and fitness assessment tests are performed by the physical trainer while the balance and are performed by a physiotherapist. The quality of life assessment and the MDS-UPDRS II rating are performed during the inclusion visit and then the final study visit (within 2 weeks) after 6 months of practice) with the coordinating neurologist. An evaluation of incidents is also carried out during this end-of-study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <85 years old,
- •Parkinson's disease diagnosed by a neurologist, treated and sensitive to dopaminergic treatment without limitation of the duration of the disease since the date of diagnosis,
- •Patient with mild to moderate postural instability (equivalent to grade 2.5 and 3 on the Hoehn and Yahr scale),
- •Naive patient of any practice of Taiso,
- •Patient available to perform the Taïso program planned in the study,
- •Patient with written informed consent
排除标准
- •Patient with a contraindication to the practice of sport
- •Pregnant woman, parturient and breastfeeding mother
- •Patient deprived of liberty by administrative or judicial decision
- •Patient admitted to a health or social facility for purposes other than that of research
- •Adults under guardianship or trusteeship or unable to express consent
- •Patient not affiliated to a social security system
- •Patient already participating in a therapeutic research protocol that aims to improve physical or mental abilities
结局指标
主要结局
Number of traumatic incident(s) and/or cardiovascular(s)
时间窗: The collection of traumatic and/or cardiovascular incidents will begin in the first Taiso class and continue until the final visit with the neurologist (6 months of collection
The main judgement criterion is the number of traumatic incident(s) and/or cardiovascular(s) during Taiso practice and on journeys between home and the site of practice until the end of patient participation in the study.
次要结局
未报告次要终点