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VirtualPark_Pediatric

No phase Interventional Dystrophinopathy Muscular Dystrophies Congenital Myopathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual-task cycling, Standard therapy.
Who it may be relevant to
Registry conditions: Dystrophinopathy, Muscular Dystrophies, Congenital Myopathies. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Slowing the Functional Motor Decline of Neuromuscular Patients in Developmental Age

Overview

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.

Interventions

  • Device Dual-task cycling
    VirtualPark is a software application connecting to a medical certified cycle/arm ergometer (i.e., TheraTrainer TIGO). The application allows for dual task training. In particular, while cycling, participants can perform one of four different available exercises. Each exercise is focused on a specific cognitive domain: Task 1: visual attention, inhibition and cognitive flexibility; Task 2: working memory; Task 3: inhibition; Task 4: navigation.
  • Other Standard therapy
    Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.

Primary outcome measures

  • Motor Function Measure-32 (MFM-32) - Total score [Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)]
Secondary outcome measures (5)
  • North Star Ambulatory Assessment (NSSA) [Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)]
  • Timed functional tests (TFTs) [Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)]
  • 6-Minute Walking Test (6MWT) [Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)]
  • Performance Upper Limb Module 2.0 scale (PUL version 2.0) [Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)]
  • Assisted-6 Minute Cycling Test (A6MWT) [Time frame: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Italy · 4 centers
  • IRCCS E. Medea - La Nostra Famiglia — Bosisio Parini
  • IRCCS Fondazione Stella Maris — Pisa
  • IRCCS Fondazione Mondino — Pavia
  • Fondazione Don Gnocchi - Centro "S. Maria al Mare" — Salerno

Identifiers

NCT: NCT07580365 · 0057550-28/04/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗