跳至主要内容
临床试验/NCT05783999
NCT05783999招募中不适用

Role of Muscle Vibration in Improving the Sense of Fatigue in Patients With Multiple Sclerosis

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
mobility

研究概览

简要总结

Multiple Sclerosis is the most common cause of neurologic chronic disability in young adults. Fatigue is one of the principal symptom in this disease.

In the past it was demonstrated how, with appropriate frequencies and amplitude of vibration, it is possible both to select the activated afferents, and to determine the frequency of action potentials sent to the Central Nervous System.

The purpose of this study is to verify how the use of vibrations can induce positive effects on the mobility and postural control of patients with MS, as well as reduce fatigue.

The study is an interventional type. The subjects are undergoing to baseline examinations (T0) including 3D gait analysis (using a BTS system), stabilometric analysis, and a battery of neuropsychological assessments. Subsequently, eligible subjects are undergoing to intensive multidisciplinary training for a total of 5 sessions per week for 4 weeks, with a total of 20 treatment sessions. The experimental group receive additional vibration treatment. At the end of the treatment cycle (T1), the patients will undergo the same evaluation tests as at baseline. The Clinical and instrumental exams used for this study (as per normal clinical practice) are: Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS), Fatigue Scale for Motor and Cognitive Functions (FSMC), Borg Scale, Medical Research Council Scale (MRC), 6 minutes walking test.

The Psychological Assessment Battery used are: Multiple Sclerosis Quality of Life-54 (MSQOL-54) scale, Beck Depression Inventory-II, Coping Orientation to Problems Experienced (COPE).

Sample size: The sample consist of patients with MS admitted to the C.A.R.E.N. or Casazza facilities of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. Twenty eligible subjects recruited and treated with traditional rehabilitation approach plus vibrational therapy. The results will be compared to those obtained from a group of 20 patients who have undergone a traditional rehabilitation treatment without the application of vibrations and who will represent the control group.

详细描述

Multiple Sclerosis is the most common cause of neurologic chronic disability in young adults.

Fatigue is one of the principal symptom in this disease. Fatigue in a subject with MS is present every day, gets worse as the day progresses, with the heat and humidity, it is sudden and more severe than normal, it interferes with physical performance. Fatigue is prevalent in the MS population and is a significant health problem, negatively impacting activities of daily living, ability to work, social life and quality of life.

In 1963 it was demonstrated how mechanical vibration, applied to a single muscle, at suitable amplitudes and frequencies, was capable of selectively and differentially activating primary (Ia), secondary (IIb) or GTO spindle afferents, depending on the characteristics of the stimulus. So with appropriate frequencies and amplitude of vibration, it is possible both to select the activated afferents, and to determine the frequency of action potentials sent to the Central Nervous System. The purpose of this study is to verify how the use of vibrations can induce positive effects on the mobility and postural control of patients with MS, as well as reduce fatigue. The study is an interventional type. The subjects are undergoing to baseline examinations (T0) including 3D gait analysis (using a BTS system), stabilometric analysis, and a battery of neuropsychological assessments. Subsequently, eligible subjects are undergoing to intensive multidisciplinary training for a total of 5 sessions per week for 4 weeks, with a total of 20 treatment sessions. The experimental group receive additional vibration treatment. At the end of the treatment cycle (T1), the patients will undergo the same evaluation tests as at baseline. The Clinical and instrumental exams used for this study (as per normal clinical practice) are: Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS), Fatigue Scale for Motor and Cognitive Functions (FSMC), Borg Scale, Medical Research Council Scale (MRC), 6 minutes walking test.

The Psychological Assessment Battery used are: Multiple Sclerosis Quality of Life-54 (MSQOL-54) scale, Beck Depression Inventory-II, Coping Orientation to Problems Experienced (COPE).

Sample size: The sample consist of patients with MS admitted to the C.A.R.E.N. or Casazza facilities of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina. Twenty eligible subjects recruited and treated with traditional rehabilitation approach plus vibrational therapy. The results will be compared to those obtained from a group of 20 patients who have undergone a traditional rehabilitation treatment without the application of vibrations and who will represent the control group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Definite diagnosis of Multiple Sclerosis according to the McDonald criteria;
  • Evidence of fatigue symptoms;
  • Age between 20 and 60;
  • Score on the EDSS scale between 1 and 5.5;
  • Signed informed consent.

排除标准

  • Pregnancy;
  • Presence of cardiac pacemaker or other implants;
  • Malignant neoplasms;
  • Presence of cardiac, pulmonary, or musculoskeletal comorbidities that contraindicate physical exercise;
  • Presence of non-healed wounds;
  • Severe visual and/or hearing impairment;

结局指标

主要结局

mobility

时间窗: 12 months

changes in motricity index

postural control

时间窗: 12 months

changes in Tinetti's scale

次要结局

  • quality of life(12 months)
  • fatigue(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta Cellini

MD

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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