Post-stroke Recovery (PSR_e2020)

NCT04323501 | Unknown

• 1 other identifier: GrantEccellenza_MIUR2020
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stroke

Keywords

Stroke; Self-management; Rehabilitation; Neuronal plasticity; Motivation; Gait; Microbiota; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• To assess the change between the time points on Fugl-Meyer assessment (FMA)

  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.

  T0 (baseline) - T1 (3 months) - T2 (6 months) - T3 (9 months) - T4 (12 months)

Secondary Outcomes (5)

• 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)

• Volumetric lesion analysis, lesion site analysis, Diffusion Tensor Imaging DTI, functional Magnetic Resonance Imaging fMRI.

  T0 (baseline) - T4 (12 months)

• Motor evoked potentials (MEP), somatosensitive evoked potentials (SSEP)

  T0 (baseline) - T4 (12 months)

• Transcranial Magnetic Stimulation (TMS)

  T0 (baseline) - T2 (6 months)

Other Outcomes (20)

• Outcome measures provided especially for the other work-packages Electroencephalography (EEG)

  T0 (baseline) - T2 (6 months)

• Outcome measures provided especially for the other work-packages Electroencephalography (EEG)

  T0 (baseline) - T2 (6 months)

• Outcome measures provided especially for the other work-packages Electroencephalography (EEG)

  T0 (baseline) - T2 (6 months)

Study Arms (2)

Experimental treatment group

EXPERIMENTAL

This group will undergo an intensive-rehabilitation treatment of post-stroke sensorimotor disability based on a "guided self-rehabilitation contract". This approach is based on the fact that the patient must complete a diary of his self-rehabilitation activity in order to verify its correct and full execution. The treatment protocol will be defined on the basis of the clinical picture (patterns) manifested by the patient (the intensity and frequency of the exercises will be adapted according to the characteristics of each patient). The duration of treatment will be the same for all patients. The exercises will be performed every day throughout the study period (12 months). Before undertaking the intensive self-management treatment, each patient will undergo 10 sessions of neurorehabilitation treatment at the UOC Neurorehabilitation of the Integrated University Hospital according to normal clinical practice, during which the patient will be provided with infographic support material.

Other: Experimental treatment

Control group

ACTIVE COMPARATOR

The patients allocated to the control group, during the study period they will undergo conventional outpatient rehabilitation treatment (usual care) at the Neurorehabilitation Unit of the AOUI according to the clinical practice through the procedures provided for by the Health System National.

Other: Control group

Interventions

Experimental treatment OTHER

Exercises may include UPPER LIMB Passive exercises (stretching), each one greater or equal to 10 minutes; greater or equal once a day: pectoralis; back muscles and triceps; subscapular muscle; elbow flexor; both pronator muscles; flexor of the wrist and fingers; flexor, adductor and opponent muscles of the thumb. Active exercises: multiple repetitions possible in 1 minute each one greater or equal to three times a day: shoulder abduction, flexion, external rotation; elbow extension and supination; wrist extension; finger extension; thumb extension and abduction. LOWER LIMB Passive exercises, each one greater or equal to 10 minutes; greater or equal once a day: hamstring; adductor of the hip; gluteus muscles. Greater or equal to 5 minutes; greater or equal to twice a day: soleus and gastrocnemius. Active exercises: multiple repetitions possible in 1 minute each one greater or equal to three times a day: hip abduction and flexion; knee flexion; dorsiflexion of ankle; seat-standing

Experimental treatment group

Control group OTHER

Usual care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• Contemporary participation in other clinical studies.
• Cognitive impairment defined as a score (corrected) for the Mini-Mental State Examination \<23.8.
• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy

Verona, 37124, Italy

RECRUITING

Related Publications (1)

• Picelli A, Filippetti M, Del Piccolo L, Schena F, Chelazzi L, Della Libera C, Donadelli M, Donisi V, Fabene PF, Fochi S, Fonte C, Gandolfi M, Gomez-Lira M, Locatelli E, Malerba G, Mariotto S, Milanese C, Patuzzo C, Romanelli MG, Sbarbati A, Tamburin S, Venturelli M, Zamparo P, Carcereri de Prati A, Butturini E, Varalta V, Smania N. Rehabilitation and Biomarkers of Stroke Recovery: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jan 15;11:618200. doi: 10.3389/fneur.2020.618200. eCollection 2020.

  PMID: 33519698 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nicola Smania, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Alessandro Picelli, PhD

  Universita di Verona

  STUDY DIRECTOR

Central Study Contacts

Nicola Smania, MD

CONTACT

+39 045 8124573; nicola.smania@univr.it

Alessandro Picelli, PhD

CONTACT

alessandro.picelli@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An experimental pilot study, randomized, controlled and is single-blind, without drug and medical device.

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 26, 2020
• Study Start: May 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

IT (1)