Post-stroke Recovery (PSR_e2020)

NCT04323501 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2022-05-23

No results posted yet for this study

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

Interventions

OTHER

Experimental treatment

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

OTHER

Control group

Usual care

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Nicola Smania, MD · Universita di Verona

  • Alessandro Picelli, PhD · Universita di Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-06-30
Completion
2024-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323501 on ClinicalTrials.gov