VirtualPark_Pediatric

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Standard therapy: Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.

Study summary

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

Primary outcome measure(s)

• Motor Function Measure-32 (MFM-32) - Total score — Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
  The Motor Function Measure-32 is a motor skills assessment scale validated for patients affected by neuromuscular pathology from 6 years of age. The instrument consists of 32 items (scored from 0 to 3) divided into 3 dimensions: D1- standing position and transfers (13 items), D2- axial and proximal motor skills (12 items) and D3- distal motor skills (7 items). The results are expressed as a percentage in relation to the maximum score. The result of each dimension corresponds to the sum of the scores obtained by the subject in the items of this dimension divided by the maximum score of the same dimension and multiplied by 100. For the MFM-32 the total score corresponds to the sum of all the scores attributed to the subject (all dimensions together) divided by 96 and multiplied by 100.

Trial sites (4)

More Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato trials in Italy

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