Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04323501
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2020-03-12
Brief Title:
Post-stroke Recovery PSR_e2020
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Rehabilitation Treatment and Biomarkers of Post-stroke Recovery a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
PSR_e2020
Brief Summary:
The study presented is part of the departmental project entitled BEHAVIORS AND WELLNESS A MULTIDISCIPLINARY APPROACH TO PROMOTE THE QUALITY OF LIFE IN VULNERABILITY CONDITIONS - winner of the MIUR grant Departments of Excellence provided by Law 232 of 2016
The departmental project has the general aim of understanding the interaction between behaviours motivational and psycho-biological aspects in a situation of neurodegenerative disease andor mental distress from which derive six different types of patients that constitute the six lines of research into which the departmental project is divided The project as all lines of research is organized into two essential phases
Phase I the creation of basic models based on the in-depth knowledge of the molecular structural and functional mechanisms both physiological and cognitive as well as on the psychological components eg the ability to cope with the disease and the implementation of strategies functionals to the well-being which are better indicative of an improvement in the health conditions of the six different patient populations studied
Phase II clinical-applicative integration in which studies will be carried out on the motivations and consequent behaviours in everyday life contexts Therefore will be highlighted actions to take place in the healthcare educational and organizational fields aimed to promote the implementation of the practices most clearly associated with improving the health conditions highlighted by basic research
The peculiarity of the studies that make the departmental project consists in the effort to encourage translational research multidisciplinarity and the integration of knowledge stimulating an innovative dialogue between the different scientific disciplinary sectors present in the department The purpose is to make evidence-based the whole path related to behaviours and strategies that promote well-being connecting biological motivational or behavioural aspects each other that make it possible to recover or not worsen the conditions of health The idea is to encourage where possible the implementation even outside or in continuity with the strictly hospital context of practices aimed at promoting the well-being and quality of life in people in conditions of vulnerability
Each of the six research lines 1 Young patients with multiple sclerosis 2 People with chronic brain stroke outcomes 3 Parkinsons disease patients with symptoms of both physical and mental fatigue 4 Preschooler population presents regulatory disturbances 5 Migrants seeking international protection 6 Population in old age and at risk of frailty is integrated into the purposes and outcome of the departmental project however each providing a specific and appropriate study protocol it is independently submitted to the approval of the Ethics Committee
The departmental project has the general aim of understanding the interaction between behaviours motivational and psycho-biological aspects in a situation of neurodegenerative disease andor mental distress from which derive six different types of patients that constitute the six lines of research into which the departmental project is divided The project as all lines of research is organized into two essential phases
Phase I the creation of basic models based on the in-depth knowledge of the molecular structural and functional mechanisms both physiological and cognitive as well as on the psychological components eg the ability to cope with the disease and the implementation of strategies functionals to the well-being which are better indicative of an improvement in the health conditions of the six different patient populations studied
Phase II clinical-applicative integration in which studies will be carried out on the motivations and consequent behaviours in everyday life contexts Therefore will be highlighted actions to take place in the healthcare educational and organizational fields aimed to promote the implementation of the practices most clearly associated with improving the health conditions highlighted by basic research
The peculiarity of the studies that make the departmental project consists in the effort to encourage translational research multidisciplinarity and the integration of knowledge stimulating an innovative dialogue between the different scientific disciplinary sectors present in the department The purpose is to make evidence-based the whole path related to behaviours and strategies that promote well-being connecting biological motivational or behavioural aspects each other that make it possible to recover or not worsen the conditions of health The idea is to encourage where possible the implementation even outside or in continuity with the strictly hospital context of practices aimed at promoting the well-being and quality of life in people in conditions of vulnerability
Each of the six research lines 1 Young patients with multiple sclerosis 2 People with chronic brain stroke outcomes 3 Parkinsons disease patients with symptoms of both physical and mental fatigue 4 Preschooler population presents regulatory disturbances 5 Migrants seeking international protection 6 Population in old age and at risk of frailty is integrated into the purposes and outcome of the departmental project however each providing a specific and appropriate study protocol it is independently submitted to the approval of the Ethics Committee
Detailed Description:
Cerebral stroke is the worlds second leading cause of death with an incidence of 67 million deaths caused each year Despite the progress made in the prevention and treatment of acute stroke it remains the main cause of disability in adulthood in industrialized countries with a prevalence of 40 as regards the degrees of disability that significantly affect common daily activities
Currently in Italy the total number of people with long-term disabilities resulting from a stroke has now exceeded one million However the rehabilitation pathways of the therapy for the stroke mainly focus on the first weeksmonths after the acute event not always taking into account patients needs sufficiently in the chronic phase of the disease 4-6 months from a stroke All this is further aggravated by the difficulty of access to treatment and by the reduction in the quality of life once the hospital phase of taking charge has ended
The actual organizational model is based on insufficient evidence regarding the mechanisms of post-injury recovery in the subacute and chronic phase of cerebral stroke together with the poor knowledge of the factors related to it and capable of influencing it This is because the mechanisms able to condition long-term recovery remain unclear the expression of which can often be interpreted as the reversibility of the functional phenomena of deconditioning deterioration typical of the chronic phase of the stroke
In this regard considering the framework of multidomain disabilities sensorimotor cognitive-behavioural autonomous and psycho-social that characterizes patients with cerebral stroke it is necessary to define different factors clinical-functional neurophysiological and neuroimaging genetic-molecular and psychological which correlates prospectively with the picture of functional recovery and long-term post-stroke disability All this in order to describe a profile of biomarkers that characterize patients with greater recovery potential on which to base the development of innovative rehabilitation protocols based in particular on the use of self-management programs and innovative technologies of long term
STUDY DESIGN This will be an experimental pilot study without drug or medical device single-blind randomized controlled trial
OBJECTIVE OF THE STUDY The general objective is the study of the effects of a protocol innovative rehabilitation based on self-management for the long-term management of the patient with cerebral stroke together with the definition of a profile of clinical-biological imaging neurophysiological and geneticmolecular biomarkers related to the effects of this better defining the post-stroke disability framework The objectives of the study are related to the research line called People suffering from chronic stroke outcomes of the departmental development project entitled BEHAVIORS AND WELLNESS A MULTIDISCIPLINARY APPROACH TO PROMOTE THE QUALITY OF LIFE IN VULNERABILITY CONDITIONS
The study is divided into several Work-packages WP In particular all registered subjects will follow WP1 The other WPs 2 - 7 will be articulated starting from WP1 on the basis of the specific characteristics of each subject included
OBJECTIVE WP1 As for WP1 the only interventional WP that defines the main research line the primary objective is to evaluate the effects of intensive self-management treatment compared to those of habitual care on sensory post-stroke sensorimotor disability The second aspect of WP1 will be to evaluate the effects of intensive self-management treatment on post-stroke cognitive disability compared to habitual care to evaluate the effects of intensive self-management treatment on post-stroke global disability compared to those of habitual care evaluate the correlation of structural and functional neuroimaging with the primary outcome volumetric lesion analysis lesion site analysis DTI fMRI evaluate the correlation of neurophysiological variables PEM PESS cortical excitability with the primary outcome
OBJECTIVE WP2 The main objective of this WP will be to evaluate in patients with ictal damage to different brain regions and investigate complex behavioural functions of fundamental importance for daily life activities In particular this WP aims to evaluate cortical plasticity mechanisms through cognitive measures of selective attention cognitive plasticity with a view to predicting plasticity in other areas eg motor in order to guide the planning of rehabilitation protocols more personalized based on the specific characteristics of each patient that take into account the post-stroke multi-domain disability
OBJECTIVE WP3 The objectives of this WP will be to explore the characteristics of fatigue global physical mental in patients suffering from brain stroke outcomes evaluate markers of the overall health status in patients with brain stroke outcomes measure the efficiency of walking in patients with brain stroke outcomes
OBJECTIVE WP4 The goal of this WP is to explore the main psychological characteristics psychopathology and the presence of psychological distress experienced by patients with stroke and consequent pain In particular the idea behind this WP consists in identifying the psychological functioning characteristics typical of the specific pathology on the one hand and the individual aspects on the other which may have an impact on the rehabilitation process The usefulness of acting on these aspects could be useful to increase the motivation for neurorehabilitation treatment and its consequent effectiveness
OBJECTIVE WP5 The objective of this WP is to study changes in the microbiota during disease and after treatment with the aim will be to identify altered bacterial populations Subsequently it will be evaluated how lifestyles movement psycho-therapeutic approach etc can modify the composition of the microbiota to bring it back to its physiological condition pre-pathology
OBJECTIVE WP6 The objective of this WP is to identify a correlation between the expression of miRNA involved in the regulation of neuroplasticity and prognosis in post-ischemic stroke patients during rehabilitation treatment
OBJECTIVE WP7 The goal of this WP is the assessment of oxidative stress in the plasma of patients at the onset of the disease and in the rehabilitation recovery phases
POPULATION Cerebral stroke patients
The population involved in WP1 will be the starting population from which to derive the population of the other WPs As for WP 5 6 7 the population will follow that of WP1 while the involvement of patients in WP 2 3 4 will take place on the basis of further inclusionexclusion criteria This means that not all patients enrolled in WP1 will be involved in WP 2 3 4
Enrollment of patients Patients in the sub-acute phase of cerebral stroke 3 months from the acute event hospitalized at the UOC Neurorehabilitation of the Integrated University Hospital of Verona AOUI will be enrolled These patients will be offered the opportunity to participate in the study in question the modalities of which will be presented according to the information document and providing the requested clarifications colloquially Once informed consent for participation in the study has been obtained the subject may be subjected to the assessments provided for by WP1 andor by the other WPs
Procedures Patients will be enrolled according to the main methods and purposes set out in WP1 Therefore all enrolled patients will undergo the evaluation and treatment procedures foreseen by WP1 In line with the presence of a post-stroke disability involving multiple domains subgroups of subjects based on their characteristics can be defined within the sample enrolled for WP1
LENGHT OF THE STUDY
First-year - Preparation phase definition of protocol and WP presentation of the protocol to the Ethics Committee and its approval initial acquisition of the devices necessary for carrying out the study and training of the staff for their use
Second third and fourth year - Clinical phase enrollment evaluation and treatment of patients data collection and analysis progressive acquisition of the devices necessary for carrying out the study and training of the staff for their use presentation of preliminary results
Last year - Final phase development and implementation of a departmental strategy aimed at integrating the different lines of research developed by the individual areas of intervention publication of the results obtained
Patient involvement 12 months
Total duration 5 years
SAMPLE SIZE Considering as the main outcome measure for WP1 the level of functional impairment measured at the FMA for which a Minimal Detectable Change value of 52 has been defined in the literature given a level alpha of 5 a power beta of 80 considering that it is a pilot study and an SD of 102 28 was calculated that a sample size of 122 total patients 61 for the experimental treatment group and 61 for the control group may be sufficient to observe any significant difference between the pre and post-treatment conditions Taking into account a possible drop-out rate of about 10 the sample size was increased by 12 total subjects 6 for the experimental treatment group and 6 for the control group reaching a final calculation of 134 patients to enrol
STATISTICAL ANALYSIS Adequate descriptive statistics will be produced for each WP 1 - 7 frequency histograms position or central trend indices mean median variability or sample dispersion indices standard deviation interquartile range construction of confidence intervals for regarding demographic data and the various variables taken into consideration at each assessment time see above
As for WP1 the comparison between the experimental treatment group and the control group subjected to usual care with regard to the outcomes considered FMA and OCS in the various evaluation times will be performed through the use of parametric tests t-test ANOVA or non-parametric Kruskal Wallis test Mann-Whitney test on the basis of data distribution Correlation and or regression analyzes will also be performed between neuroimaging data structural and functional neurophysiological variables and the main clinical outcome FMA at the various assessment times
With regard to the remaining WPs 2 - 7 the statistical significance of the variations between groups relative to the variables assessed at different times vide supra will be assessed through the use of parametric t-test ANOVA or non-parametric tests Kruskal Wallis test Mann-Whitney test based on data distribution For each variable considered both longitudinally and transversely correlation andor regression analyzes will also be performed with the main clinical outcome FMA and OCS of WP1 at the different evaluation times
Finally for each WP the statistical significance of the variations with respect to the variables assessed longitudinally intra-group at different times vide supra will be assessed through the use of parametric tests t-test ANOVA or non-parametric tests Friedman test Wilcoxon test based on data distribution
The statistical analysis will be performed using the Statistical Package for Social Science SPSS version 260 software for Macintosh SPSS Inc Chicago IL USA For all statistical tests the significance level is set at 5
Currently in Italy the total number of people with long-term disabilities resulting from a stroke has now exceeded one million However the rehabilitation pathways of the therapy for the stroke mainly focus on the first weeksmonths after the acute event not always taking into account patients needs sufficiently in the chronic phase of the disease 4-6 months from a stroke All this is further aggravated by the difficulty of access to treatment and by the reduction in the quality of life once the hospital phase of taking charge has ended
The actual organizational model is based on insufficient evidence regarding the mechanisms of post-injury recovery in the subacute and chronic phase of cerebral stroke together with the poor knowledge of the factors related to it and capable of influencing it This is because the mechanisms able to condition long-term recovery remain unclear the expression of which can often be interpreted as the reversibility of the functional phenomena of deconditioning deterioration typical of the chronic phase of the stroke
In this regard considering the framework of multidomain disabilities sensorimotor cognitive-behavioural autonomous and psycho-social that characterizes patients with cerebral stroke it is necessary to define different factors clinical-functional neurophysiological and neuroimaging genetic-molecular and psychological which correlates prospectively with the picture of functional recovery and long-term post-stroke disability All this in order to describe a profile of biomarkers that characterize patients with greater recovery potential on which to base the development of innovative rehabilitation protocols based in particular on the use of self-management programs and innovative technologies of long term
STUDY DESIGN This will be an experimental pilot study without drug or medical device single-blind randomized controlled trial
OBJECTIVE OF THE STUDY The general objective is the study of the effects of a protocol innovative rehabilitation based on self-management for the long-term management of the patient with cerebral stroke together with the definition of a profile of clinical-biological imaging neurophysiological and geneticmolecular biomarkers related to the effects of this better defining the post-stroke disability framework The objectives of the study are related to the research line called People suffering from chronic stroke outcomes of the departmental development project entitled BEHAVIORS AND WELLNESS A MULTIDISCIPLINARY APPROACH TO PROMOTE THE QUALITY OF LIFE IN VULNERABILITY CONDITIONS
The study is divided into several Work-packages WP In particular all registered subjects will follow WP1 The other WPs 2 - 7 will be articulated starting from WP1 on the basis of the specific characteristics of each subject included
OBJECTIVE WP1 As for WP1 the only interventional WP that defines the main research line the primary objective is to evaluate the effects of intensive self-management treatment compared to those of habitual care on sensory post-stroke sensorimotor disability The second aspect of WP1 will be to evaluate the effects of intensive self-management treatment on post-stroke cognitive disability compared to habitual care to evaluate the effects of intensive self-management treatment on post-stroke global disability compared to those of habitual care evaluate the correlation of structural and functional neuroimaging with the primary outcome volumetric lesion analysis lesion site analysis DTI fMRI evaluate the correlation of neurophysiological variables PEM PESS cortical excitability with the primary outcome
OBJECTIVE WP2 The main objective of this WP will be to evaluate in patients with ictal damage to different brain regions and investigate complex behavioural functions of fundamental importance for daily life activities In particular this WP aims to evaluate cortical plasticity mechanisms through cognitive measures of selective attention cognitive plasticity with a view to predicting plasticity in other areas eg motor in order to guide the planning of rehabilitation protocols more personalized based on the specific characteristics of each patient that take into account the post-stroke multi-domain disability
OBJECTIVE WP3 The objectives of this WP will be to explore the characteristics of fatigue global physical mental in patients suffering from brain stroke outcomes evaluate markers of the overall health status in patients with brain stroke outcomes measure the efficiency of walking in patients with brain stroke outcomes
OBJECTIVE WP4 The goal of this WP is to explore the main psychological characteristics psychopathology and the presence of psychological distress experienced by patients with stroke and consequent pain In particular the idea behind this WP consists in identifying the psychological functioning characteristics typical of the specific pathology on the one hand and the individual aspects on the other which may have an impact on the rehabilitation process The usefulness of acting on these aspects could be useful to increase the motivation for neurorehabilitation treatment and its consequent effectiveness
OBJECTIVE WP5 The objective of this WP is to study changes in the microbiota during disease and after treatment with the aim will be to identify altered bacterial populations Subsequently it will be evaluated how lifestyles movement psycho-therapeutic approach etc can modify the composition of the microbiota to bring it back to its physiological condition pre-pathology
OBJECTIVE WP6 The objective of this WP is to identify a correlation between the expression of miRNA involved in the regulation of neuroplasticity and prognosis in post-ischemic stroke patients during rehabilitation treatment
OBJECTIVE WP7 The goal of this WP is the assessment of oxidative stress in the plasma of patients at the onset of the disease and in the rehabilitation recovery phases
POPULATION Cerebral stroke patients
The population involved in WP1 will be the starting population from which to derive the population of the other WPs As for WP 5 6 7 the population will follow that of WP1 while the involvement of patients in WP 2 3 4 will take place on the basis of further inclusionexclusion criteria This means that not all patients enrolled in WP1 will be involved in WP 2 3 4
Enrollment of patients Patients in the sub-acute phase of cerebral stroke 3 months from the acute event hospitalized at the UOC Neurorehabilitation of the Integrated University Hospital of Verona AOUI will be enrolled These patients will be offered the opportunity to participate in the study in question the modalities of which will be presented according to the information document and providing the requested clarifications colloquially Once informed consent for participation in the study has been obtained the subject may be subjected to the assessments provided for by WP1 andor by the other WPs
Procedures Patients will be enrolled according to the main methods and purposes set out in WP1 Therefore all enrolled patients will undergo the evaluation and treatment procedures foreseen by WP1 In line with the presence of a post-stroke disability involving multiple domains subgroups of subjects based on their characteristics can be defined within the sample enrolled for WP1
LENGHT OF THE STUDY
First-year - Preparation phase definition of protocol and WP presentation of the protocol to the Ethics Committee and its approval initial acquisition of the devices necessary for carrying out the study and training of the staff for their use
Second third and fourth year - Clinical phase enrollment evaluation and treatment of patients data collection and analysis progressive acquisition of the devices necessary for carrying out the study and training of the staff for their use presentation of preliminary results
Last year - Final phase development and implementation of a departmental strategy aimed at integrating the different lines of research developed by the individual areas of intervention publication of the results obtained
Patient involvement 12 months
Total duration 5 years
SAMPLE SIZE Considering as the main outcome measure for WP1 the level of functional impairment measured at the FMA for which a Minimal Detectable Change value of 52 has been defined in the literature given a level alpha of 5 a power beta of 80 considering that it is a pilot study and an SD of 102 28 was calculated that a sample size of 122 total patients 61 for the experimental treatment group and 61 for the control group may be sufficient to observe any significant difference between the pre and post-treatment conditions Taking into account a possible drop-out rate of about 10 the sample size was increased by 12 total subjects 6 for the experimental treatment group and 6 for the control group reaching a final calculation of 134 patients to enrol
STATISTICAL ANALYSIS Adequate descriptive statistics will be produced for each WP 1 - 7 frequency histograms position or central trend indices mean median variability or sample dispersion indices standard deviation interquartile range construction of confidence intervals for regarding demographic data and the various variables taken into consideration at each assessment time see above
As for WP1 the comparison between the experimental treatment group and the control group subjected to usual care with regard to the outcomes considered FMA and OCS in the various evaluation times will be performed through the use of parametric tests t-test ANOVA or non-parametric Kruskal Wallis test Mann-Whitney test on the basis of data distribution Correlation and or regression analyzes will also be performed between neuroimaging data structural and functional neurophysiological variables and the main clinical outcome FMA at the various assessment times
With regard to the remaining WPs 2 - 7 the statistical significance of the variations between groups relative to the variables assessed at different times vide supra will be assessed through the use of parametric t-test ANOVA or non-parametric tests Kruskal Wallis test Mann-Whitney test based on data distribution For each variable considered both longitudinally and transversely correlation andor regression analyzes will also be performed with the main clinical outcome FMA and OCS of WP1 at the different evaluation times
Finally for each WP the statistical significance of the variations with respect to the variables assessed longitudinally intra-group at different times vide supra will be assessed through the use of parametric tests t-test ANOVA or non-parametric tests Friedman test Wilcoxon test based on data distribution
The statistical analysis will be performed using the Statistical Package for Social Science SPSS version 260 software for Macintosh SPSS Inc Chicago IL USA For all statistical tests the significance level is set at 5
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?:
None
Is an FDA AA801 Violation?:
None