About this trial
The study will involve boys with Duchenne Muscular Dystrophy (DMD), from adolescence to adulthood living in Italy, and their families/ caregivers.
The Investigators want to explore patients' mental health, social cognition and perception of body image as well as patients'and caregivers' ability to adapt to changes related to both the disease and various personal and social needs, through the use of short and simple questionnaires, neuropsychological tests and neurocognitive evaluation in ecological scenarios using Virtual Reality. The desire for autonomy and the awareness of both personal and social difficulties in achieving them put a strain on both patients and their families.Some studies conducted in the USA and in various European countries underline that the transition to adulthood of patients with muscular dystrophy is featured by a good ability to adapt to the more advanced stages of the disease in general; nevertheless, facing the worsening of health entails experiences of anxiety and depression.In this historical phase, clinical trials of gene therapy and gene modulating therapies are involving an increasing number of patients, mainly represented by children in the early phase of the disease. Hence, adolescents and young adults could develop feelings of exclusion from research efforts, losing confidence and hope in any future improvement of their condition, social participation and quality of life.This study could lead to identify strengths and weaknesses in social cognition and psychosocial adaptation; through the evaluation of characteristics of patients/caregivers or exogenous factors influencing higher levels of social adaptation, we ultimately aim to define strategies to improve not only physical (already defined by guidelines) but also psychological care, social cognition and social support in all stages of DMD, particularly in later ones.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Defined diagnosis of DMD
Age > 14 years
Willingness and ability to comply to study procedures
Comprehension of the study and Signature of the informed consent
Disqualifiers
Clinical history of cerebral palsy, severe intellectual deficit, severe behavioral disturbances
absence of compliance to the studyof the patient and the caregivers.
Trial design
Single group
Treatments tested in this trial
VIRTUAL REALITY
DeviceThe interventional part of the study is limited to 3 centers. It explores SOCIAL COGNITION throught a newly developed paradigm in Virtual Reality. In detail: an adapted version of the Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) using a VR Head Mounted Display (HMD) will be implemented on a portable HMD, the Oculus Quest, equipped with two controllers with motion sensors that are used to track hand position. In a VR-SPIRIT session, participants are immersed in the playground scenario and engaged in a competition with four avatars. Each avatar has a pre-established probability to move toward one of the three described games. Different indices about a partecipant's performance are recorded automatically by the system during the session, such as the duration of each trial and the prediction score (percentage of trials in which the participant correctly predicted an avatar's intention).
Treatment groups
Trial outcomes
Primary outcomes
psychosocial adjustment, mental health and coping strategies
To assess psychosocial adjustment, mental health and coping strategies through standardized measures in a large population of teenagers and adults with DMD and their caregivers
social cognition
To test social cognition mechanisms with standardized neuropsychological evaluation and newly-developed cognitive neuroscience paradigms that investigate emotional and social processing in ecological settings using Virtual reality in a subsample of partecipants
body image
To explore body image perception and assess its impact on psychological well-being exploring the role of cognitive and motor impairment as possible mediators
Correlation with medical conditions
To investigate the interaction patterns between medical conditions and test on social cognition, psychosocial adjustment, mental health and coping strategies, to identify strengths to be supported and weaknesses to be reduced or counterbalanced.
Sponsors and contacts
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IRCCS Eugenio Medea
Lead sponsor
University of Padova
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Istituto Giannina Gaslini - IRCCS
Collaborator
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Collaborator
Centro Clinico NeMO Ancona
Collaborator
IRCCS Fondazione Stella Maris
Collaborator
Università degli Studi di Milano Statale
Collaborator
Centro Clinico NeMO Brescia
Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator
I.R.C.C.S. Eugenio Medea - Associazione La Nostra Famiglia - Sede di Conegliano
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Dipartimento di Neuroscienze Rita Levi Montalcini Torino
Collaborator
Università Vita-Salute San Raffaele
Collaborator
Università di Pisa
Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator
Associazione La Nostra Famiglia Eugenio Medea - Brindisi
Collaborator
Scientific Institute, IRCCS E.Medea, Pasian di Prato
Collaborator
IRCCS Istituto delle Scienze Neurologiche di Bologna
Collaborator
This trial is not recruiting at the moment. You can still explore other options: