Effects of Musical Treadmill Training vs Traditional Treadmill Training on Gait Parameters in Patinets With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 6 Minutes Walking Test
研究概览
简要总结
In order to evaluate the effectiveness of musical treadimll on gait parameters in patients with Parkinson's Disease, the investigators compare the outcome measures on two group of patients: one will undergo a 4-week daily musical treadmill training and one will undergo a 4-week daily traditional treadmill training
详细描述
Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training is useful in improving the gait's parameters in patients in early-moderate stages of disease. Moreover, it has been shown that the music, exploiting the entrainment, is effective in order to ameliorate several gait parameters, as step lenghts and cadence. No data are available about the effectiveness of the association between treadmill and music. The aim of this study is to evaluate the effect of a gait training using musical treadmill in patients in stages I-II-III Hoehn & Yahr (H&Y).
100 patients with PD in early-moderate stage of disease will be enrolled. All patients will undergo an intensive treatment: 2 session of 20-minutes treadmill training per day, 5 times a week, for 4 weeks. Treadmill speed will be previously set at 20% less the confidence speed and progressively increased of 20%. All patients will be evaluat at the enrolment and at the end of the treatment. The outcome misures are: 6 Minute Walking Test and Timed Up and Go Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 2.5-3 according to the Hoehn and Yahr scale (H&Y);
- •Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
- •Mini Mental State Examination (MMSE) ≥ 24;
排除标准
- •Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
- •Drug-induced dyskinesias;
- •Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
- •Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
- •Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
研究组 & 干预措施
musical treadmill
4-week daily musical treadmill training, consisting in two session, 20 minute per session
干预措施: musical treadmill (Behavioral)
traditional session
4-week daily traditional treadmill training, consisting in two session, 20 minute per session
干预措施: Traditional treadmill (Behavioral)
结局指标
主要结局
6 Minutes Walking Test
时间窗: 4 week
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes
Timed up and Go Test
时间窗: 4 week
The TUG is aimed to measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning
次要结局
未报告次要终点
研究者
Luca Sebastianelli
MD
Ospedale Generale Di Zona Moriggia-Pelascini