Muscle Vibration and Fatigue in Patients With MS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: vibra plus

Detailed Description

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.

A descriptive analysis of the two groups will be performed for clinical and socio-demographic variables. The Shapiro-Wilk test will be applied to assess the distribution of variables. Subsequently, continuous variables will be expressed as mean±sd or median and I-III quartile, while categorical variables in frequency and percentages. An intra-group analysis will be carried out to compare both clinical and instrumental scores between T0 and T1 in each group using either T-Student or Wilcoxon for paired data, and a Pearson correlation or Spearman rank correlation to evaluate the relationship between clinical scales and instrumental data. The inter-group analysis will be applied to compare both clinical and instrumental scores between the groups at T0 and T1 using either a parametric test (T-Student for unpaired data) or a non-parametric test (U-Mann Whitney). The analysis will be performed using the open-source software R3.0. A confidence interval of 95% with a 5% alpha error will be considered. Statistical significance will be set at p<0.05.

The principal investigator (PI) will conduct the study in accordance with good clinical practice (GCP) guidelines and current regulations, and in accordance with the current version of the Declaration of Helsinki.

All study participants will sign informed consent in accordance with current regulations. The study investigator will inform the subject that participation in the protocol is voluntary and that refusal will not in any way affect the relationship with the researcher. Before enrollment in the study, each subject will receive a clear explanation of the nature and purpose of the study from the investigator. A clear information sheet outlining all salient aspects will also be provided in hard copy to the subject, who will have the opportunity to ask any questions and raise any concerns regarding the contents. Additionally, the subject will be given ample time to decide whether to participate in the study before signing the informed consent in duplicate. The original signed informed consent will be retained by the investigator.

Before carrying out any examination provided by this protocol, patients will also provide all authorizations required by law (European Regulation 2016/679, Legislative Decree 196/2003 modified by Legislative Decree no. 101 of 10/08/2018) and by the provisions of the Privacy Guarantor. In accordance with good clinical practice rules, each subject will be uniquely identified by a code, which will be the subject identifier for the entire duration of the studY.

The experimenter will wait for approval from the Ethics Committee. The study in question will be conducted according to the attached protocol, in compliance with the expected timelines, the Declaration of Helsinki (1964 and subsequent amendments), in compliance with Good Clinical Practice guidelines, and in accordance with current regulations.

The study does not involve any additional costs for the institution, nor any external sources of funding of any kind. There is no compensation planned for the study's principal investigator or the involved experimenters. The institution and experimenters are covered by adequate insurance coverage for any damages that may arise from the experimentation.

The proposer agrees to prepare a final report at the conclusion of the study and to make the results publicly available.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Messina, Sicily, Italy, 98121
      • Recruiting
      • Irccs Neurolesi Centro Bonino Pulejo
      • Contact: Roberta Cellini, MD; Phone Number: 09060128100; Email: roberta.cellini@irccsme.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard care + vibra plus; patients will undergo treatment with the vibra plus device on top of traditional rehabilitation	Device: vibra plus; the device is applied to the patient's lower limbs and generates an active flow of vibrations that may reduce fatigue
No Intervention: Standard care; patients undergo a traditional rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mobility	changes in motricity index	12 months
postural control	changes in Tinetti's scale	12 months
postural control	changes in Berg's scale	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fatigue	changes in the Fatigue Severity Scale (FSS)	12 months
fatigue	changes in the Modified Fatigue Impact Scale (MFIS)	12 months
fatigue	changes in the Fatigue Scale for Motor and Cognitive Functions (FSMC)	12 months
fatigue	changes in the Borg Scale	12 months
fatigue	changes in the Medical Research Council Scale (MRC)	12 months
quality of life	changes in the Multiple Sclerosis Quality of Life-54 (MSQOL-54) scale	12 months
quality of life	changes in the Coping Orientation to Problems Experienced (COPE) questionnaire	12 months

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: VIBRATIPLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No