Evaluation of the Impact of Experimentally Induced Fatigability on Motor and Cognitive Functions. Effect of High Intensity Training on Motor and Cognitive Functions:a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- difference in walking velocity during the fatiguing walking test
研究概览
简要总结
Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders.
However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions.
Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years of age
- •Clinical diagnosis of Multiple Sclerosis (MS)
- •Stable disease course without worsening more than 1 EDSS point over the last 3 months, -EDSS between 1.5 and 6 points
- •Must be able to maintain upright posture without any assistance for 30 seconds
- •Must be able to release a written informed consent.
排除标准
- •MS relapse within the previous three months;
- •Unable to comprehend the aims of the study and to follow test instructions;
- •Diagnosis of major depression (DSM-5);
- •Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
- •Cardiovascular diseases;
- •Unconfirmed or uncertain diagnosis of MS (McDonald criteria)
- •Other concomitant neurological disease;
- •Patients already performing aerobic or walking exercise.
研究组 & 干预措施
Multimodal functional training
Multimodal training to reduce fatigue and to improve balance and strength
干预措施: Multimodal functional training (Other)
Usual care
Rehabilitative intervention to improve balance and mobility
干预措施: Usual care (Other)
结局指标
主要结局
difference in walking velocity during the fatiguing walking test
时间窗: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
difference between velocity at the beginning of the test and velocity at the end of the fatiguability walking test, \[m/s\]
次要结局
- gait asymmetry and gait regularity(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Brief International Cognitive Assessment in Multiple Sclerosis (BICAMS)(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Antero-posterior and medio-lateral accelerations in stabilometric tasks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))