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

Status unknownNot a drug-phase studyMS (type not specified)NCT05783999

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • vibra plus

What it measured

Main measures

  • mobility

    12 months

    Walking and mobilityPhysical function
  • postural control

    12 months

Other measures (2)

  • fatigue

    12 months

    FatigueThinking and memory
  • quality of life

    12 months

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 20 to 60 · EDSS 1 to 5.5

Show the full criteria

Inclusion criteria

* 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.

Exclusion criteria

* 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;

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Oct 2021

    2. Main results due

      Jun 2024

    3. Finished

      Jun 2024

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