VirtualPark_Pediatric
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorIstituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
About this trial
The goal of this clinical trial is to assess the effects of a dual-task, multimodal training program on slowing functional motor decline in children and adolescents with neuromuscular disorders. The main questions it aims to answer are:
Does Virtual Park slow functional motor decline in children and adolescents with neuromuscular diseases compared with standard therapy?
Does Virtual Park contribute to increased engagement and improved neuropsychological function?
If there is a comparison group, Researchers will compare dual-task cycling supported by the Virtual Park application to standard therapy to see whether it improves motor and neuropsychological functions and engagement.
Participants will undergo two phases:
* Phase 1: 3 months of standard therapy; * Phase 2: 3 months of experimental conditions in which patients undergo a rehabilitative intervention with Virtual Park, 3 times a week.
Eligibility criteria
Qualifiers
availability of a definitive clinical or molecular genetic diagnosis of a neuromuscular disease;
age between 6 years and 17 years and 11 months (inclusive);
height compatible with the use of the Thera-Trainer (minimum 120 cm);
performance Upper Limb Module 2.0 assessment: Entry level >= 2
Disqualifiers
other concomitant genetic diseases;
presence of visual impairments that prevent access to the experimental virtual reality protocol;
concomitant compromised cardio-respiratory function that contraindicates cycle ergometer training;
severe osteoporosis.
Trial design
Treatments tested in this trial
- Dual-task cycling
- Standard therapy
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Lead sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
IRCCS Eugenio Medea
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator
IRCCS Fondazione Stella Maris
Collaborator
Source ClinicalTrials.gov