Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05783999 |
| Other study ID # |
VIBRATIPLA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 28, 2021 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
IRCCS Centro Neurolesi "Bonino-Pulejo" |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
