Pilot Study on Feasibility and Safety of a Gait Auto-rehabilitation Program by Rhythmic Auditory Cueing Delivered by BeatHealth in Patients With Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 主要终点
- Percentage of time of use of the BeatHealth device compared to the prescribed schedule
研究概览
简要总结
Physical activity has demonstrated its beneficial effect on functional capabilities and quality of life in patients with PD. However, the daily physical activity remains limited in these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in patients with PD. The first results of BeatHealth studies have allowed us to identify the best musical stimulation to improve these parameters and the motivation of the patients.
The originality of this study is to propose a gait auto-rehabilitation program using BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in PD.
Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait parameters, balance, quality of life) will be evaluated.
详细描述
Objectives Main goal: To evaluate the observance of the use of BeatHealth device in gait auto-rehabilitation program in patients with PD.
Secondary objectives :
- To evaluate safety by the number of falls
- To evaluate tolerance by the evaluation of pain and fatigue
- To evaluate the expected improvement on gate and quality of life essentialy
- To identify predictive factors associated with a good response to the program
- To evaluate the technical feasibility.
Methods Design : prospective and descriptive study Population : 60 patients with PD Inclusion criteria : PD diagnosed according the international criteria form the United Kingdom Parkinson's Disease Society Brain Bank ; gait disorder identified by the neurologist or the rehabilitation doktor ; to be able to work 30 minutes consecutively and without technical support Non inclusion criteria : signs for atypical parkinsonism
Main evaluation criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease confirmed by the United Kingdom Parkinson's Disease Society Brain Bank's criteria (Gibb and Lees, 1988; Hughes et al., 1992)
- •Gait disorder confirmed by a neurologist
- •Ability to walk more than 30 minutes without any device as a stick or a walker
- •Stability of the dopaminergic treatment
排除标准
- •Pregnancy
- •Hearing problems
- •Other neurological disease affecting gait other than PD
- •Other gait disorder whetever the etiology (orthopedic, rheumatologic....)
- •Uncompensated heart or respiratory failure excluding possibility of intensiv rehabilitation.
- •Arguments for atypical parkinsonism
结局指标
主要结局
Percentage of time of use of the BeatHealth device compared to the prescribed schedule
时间窗: 4 weeks
measured automatically by Beathealth device
次要结局
- Auto-evalation of the number of falls reported by the patient on a daily agenda(4 weeks)