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VirtualPark_Pediatric

RecruitingNAAges 6 Years - 18 YearsAllIstituto di Sistemi e Tecnologie Industriali Inte…
NCT07580365 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • Dual-task cycling
  • Standard therapy
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Where

4 sites
IRCCS E. Medea - La Nostra Famiglia
Bosisio Parini, Italy
IRCCS Fondazione Stella Maris
Pisa, Italy
IRCCS Fondazione Mondino
Pavia, Italy
Fondazione Don Gnocchi - Centro "S. Maria al Mare"
Salerno, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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