Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05783999
Status:
RECRUITING
Last Update Posted:
2023-04-07
First Post:
2023-03-14
Brief Title:
Muscle Vibration and Fatigue in Patients With MS
Sponsor:
IRCCS Centro Neurolesi Bonino-Pulejo
Organization:
IRCCS Centro Neurolesi Bonino-Pulejo
Study Overview
Official Title:
Role of Muscle Vibration in Improving the Sense of Fatigue in Patients With Multiple Sclerosis
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CAREN 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
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 CAREN 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 CAREN 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 meansd 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 R30 A confidence interval of 95 with a 5 alpha error will be considered Statistical significance will be set at p005
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 2016679 Legislative Decree 1962003 modified by Legislative Decree no 101 of 10082018 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 studys 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
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 CAREN 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 meansd 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 R30 A confidence interval of 95 with a 5 alpha error will be considered Statistical significance will be set at p005
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 2016679 Legislative Decree 1962003 modified by Legislative Decree no 101 of 10082018 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 studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None