Muscle Vibration and Fatigue in Patients With MS

NCT05783999 | Unknown

• 1 other identifier: VIBRATIPLA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• fatigue

  12 months

• fatigue

  12 months

• fatigue

  12 months

• fatigue

  12 months

• fatigue

  12 months

Study Arms (2)

standard care + vibra plus

EXPERIMENTAL

patients will undergo treatment with the vibra plus device on top of traditional rehabilitation

Device: vibra plus

Standard care

NO INTERVENTION

patients undergo a traditional rehabilitation program

Interventions

vibra plus DEVICE

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

standard care + vibra plus

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Neurolesi Centro Bonino Pulejo

Messina, Sicily, 98121, Italy

RECRUITING

Related Publications (1)

• Formica C, Latella D, Bonanno L, Lombardo Facciale A, Paladina G, Leo A, Pergolizzi L, Fonti B, Quartarone A, Cellini R, Calabro RS. The Role of VibraPlus on Fatigue in Multiple Sclerosis Patients: A Randomized Controlled Trial. J Clin Med. 2025 Jun 5;14(11):3990. doi: 10.3390/jcm14113990.

  PMID: 40507752 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 24, 2023
• Study Start: October 28, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)