Rehabilitation Treatment and Biomarkers of Post-stroke Recovery: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- To assess the change between the time points on Fugl-Meyer assessment (FMA)
研究概览
简要总结
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 and/or 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 (e.g. 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. Parkinson's 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.
详细描述
Cerebral stroke is the world's second leading cause of death with an incidence of 6.7 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 weeks/months after the acute event, not always taking into account patient's 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The population involved in work-package (WP) 1 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 inclusion/
排除标准
- •. This means that not all patients enrolled in WP1 will be involved in WP 2, 3,
- •WP 1, 5, 6, 7 Inclusion criteria
- •Age over 18 years;
- •First diagnosis of ischemic brain stroke (ICD9-CM 446, 434) documented radiologically (CT or MRI).
- •Presence of post-stroke multidomain disability assessed with Fugl-Meyer assessment (FMA) and with Oxford Cognitive Screen (OCS).
- •Patients in the sub-acute phase of cerebral stroke (<3 months from the event) inpatients of the UOC Neurorehabilitation of the Integrated University Hospital of Verona for which the need to continue taking care of post-hospitalization rehabilitation was found.
- •The ability of the subject and/or caregiver to understand the instructions provided for the self-management of home disability
- •Signature of informed consent
- •Exclusion criteria
- •Contemporary participation in other clinical studies.
- •Cognitive impairment defined as a score (corrected) for the Mini-Mental State Examination <23.
- •Substance abuse.
- •Other neurological and orthopaedic pathologies capable of interfering with the study.
- •Particularly vulnerable populations cannot be included in the study:
- •patients with judicial interdiction
- •patients for whom a legal guardian has been appointed
- •institutionalized patients
- •Criteria for exit from the study
- •Relapse of disease during the study period
- •Withdrawal of informed consent to participate in the study
- •Impossibility to carry out the assessments foreseen by the study protocol or the rehabilitation treatment according to the defined schedule.
- •Description of the pathologies studied Outcomes of cerebral stroke with ischemic aetiology (ICD9-CM 446, 434).
- •WP2 criteria Inclusion criteria
- •See inclusion criteria WP 1
- •Presence of specific cognitive disorders as assessed by OCS
- •Adequate comprehension skills as assessed through the OCS Semantic Test Exclusion criteria
- •See exclusion criteria WP 1
- •Limited sustained attention span as assessed during the neuropsychological assessment.
- •WP3 criteria Inclusion criteria
- •See inclusion criteria WP 1
- •patients suffering from cerebral stroke outcomes in chronic phase (after 3 months from the acute event) or post-hospital discharge
- •independent gait or by means of aids (eg cane)
- •Adequate comprehension skills as assessed through the OCS Semantic Test Exclusion criteria
- •See exclusion criteria WP 1
- •WP4 criteria Inclusion criteria
- •See inclusion criteria WP 1
- •Presence of pain following a stroke assessed by Brief Pain Inventory -I
- •Adequate understanding and production skills as assessed through OCS language tests Exclusion criteria
- •See exclusion criteria WP 1
- •Presence of moderate/severe cognitive disorders assessed by OCS which could compromise the insight and communication skills necessary to fill in specific psychological questionnaires.
结局指标
主要结局
To assess the change between the time points on Fugl-Meyer assessment (FMA)
时间窗: T0 (baseline) - T1 (3 months) - T2 (6 months) - T3 (9 months) - T4 (12 months)
The FMA allows quantifying the degree of post-stroke disability through the evaluation of the following 5 domains of interest. In the upper and lower limbs: the motor function; sensory function; the range of motion; joint pain. The last domain is balance control.
次要结局
- Volumetric lesion analysis, lesion site analysis, Diffusion Tensor Imaging DTI, functional Magnetic Resonance Imaging fMRI.(T0 (baseline) - T4 (12 months))
- Oxford Cognitive Screen (OCS)(T0 (baseline) - T1 (3 months) - T2 (6 months) - T3 (9 months) - T4 (12 months))
- Barthel Index (BI)(T0 (baseline) - T1 (3 months) - T2 (6 months) - T3 (9 months) - T4 (12 months))
- Transcranial Magnetic Stimulation (TMS)(T0 (baseline) - T2 (6 months))
- Motor evoked potentials (MEP), somatosensitive evoked potentials (SSEP)(T0 (baseline) - T4 (12 months))
研究者
Nicola Smania, MD, Clinical Professor
Professor
Universita di Verona