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Muscle Vibration and Fatigue in Patients With MS

NCT05783999 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

vibra plus

the device is applied to the patient's lower limbs and generates an active flow of vibrations that may reduce fatigue

Sponsors & Collaborators

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783999 on ClinicalTrials.gov