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临床试验/NCT04090996
NCT04090996已完成不适用

Ffects of A Dual-Task Intervention in Postural Control in Multiple Sclerosis Patients With Low Level of Disability

University Hospital, Limoges1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Oscillation rate

研究概览

简要总结

Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease affecting the central nervous system. It is the leading cause of severe non-traumatic disability in young adults (20-40 years). It affects more than 540,000 individuals in Europe and around 2.8 million people worldwide. The etiology of MS remains unknown to date, but probably results from a genetic predisposition associated with environmental factors (vitamin D deficiency, tobacco, vaccines, stress, diet, ...). MS is a neurological disease in which demyelination and axonal loss lead to many symptoms such as fatigue, spasticity, decreased sensitivity, muscle weakness, balance disorders, oculomotor visuals.

The Expanded Disability Status Scale (EDSS), which is used to rate functional disorders in MS patients, tends to underestimate these neurological disorders, which are often present in the early stages of the disease and are an important issue. major in the management and evolution of the disease.

Recently, it has been shown that motor and cognitive disorders appear in the early stages of the disease, yet these functions are not systematically evaluated in the early stages of the disease. These isolated or associated disorders often lead to real difficulties in realizing everyday activities. Since this disease affects young people who still have a professional activity, it is important not to underestimate the presence of these functional and cognitive disorders.

It is therefore necessary to seek more precise means of evaluation to detect certain neurological disorders.

Thus, the evaluation of these functions participates in the follow-up of the patient and makes it possible to better apprehend the evolution of these disorders in MS.

The investigators will use the concept of double-task to measure and evaluate these functional and cognitive disorders.

The dual task (DT) , is defined by the simultaneous completion of two tasks, one called "primary" and the other called "secondary", for which the performance changes are measured. The dual task paradigms are based on the assumption that two concurrently performed tasks interfere if they use identical functional and / or brain subsystems. In the case of a paradigm involving walking and another task, the interference is based on the assumption of the joint play of attention. The primary task is then the "attentional" task and the secondary task is represented by walking. Observed inferences are changes in the performance of one or both tasks that are measured by comparing single and dual task performance.

The assessment of DT's capabilities would improve the early detection of motor disorders in MS patients. Early identification of postural instability would make it easier to target care and improve patient follow-up. Conducting work on the concept of DT would improve our knowledge of this paradigm in MS.

Finally, a better understanding of double-stained mechanisms in MS could offer training programs

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient aged 18 to 65 years old;
  • relapsing-remitting MS (RR);
  • able to hold the station standing 180s without a device assistance;
  • Expanded Disability Status Scale <4;
  • able to give informed consent to participate in this study ;
  • without any push in the 60 days before the participation in this study (to be clinically stable);
  • no change in the treatment of MS since at least 2 month.

排除标准

  • acute illness other than MS during the past 60 days;
  • neurological and psychiatric diseases, except the SEP ;
  • orthopedic and rheumatological disorders that may affect the market ;
  • visual acuity <7/10 for the best eye after correction visual;
  • patient undergoing psychiatric care;

研究组 & 干预措施

DT patients

Experimental

干预措施: Dual TAsk (Diagnostic Test)

结局指标

主要结局

Oscillation rate

时间窗: DAy 1

The presence of postural instability is determined by a value of oscillation rate greater than 2 standard deviations from the mean of the healthy population used in this study

次要结局

未报告次要终点

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (1)

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