Role of Muscle Vibration in Improving the Sense of Fatigue in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- mobility
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
mobility
Time Frame: 12 months
changes in motricity index
postural control
Time Frame: 12 months
changes in Tinetti's scale
Secondary Outcomes
- quality of life(12 months)
- fatigue(12 months)
Investigators
Roberta Cellini
MD
IRCCS Centro Neurolesi "Bonino-Pulejo"
