VirtualPark_Pediatric

NCT07580365 | Not Yet Recruiting

• 1 other identifier: 0057550-28/04/2026
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Dystrophinopathy; Muscular Dystrophies; Congenital Myopathies

Keywords

Sports for Persons with Disabilities; Rehabilitation; Neuromuscular Diseases; Dual-Task Exercises; Virtual Reality; Children with Disabilities

Outcome Measures

Primary Outcomes (1)

• Motor Function Measure-32 (MFM-32) - Total score

  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.

  Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

Secondary Outcomes (5)

• North Star Ambulatory Assessment (NSSA)

  Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

• Timed functional tests (TFTs)

  Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

• 6-Minute Walking Test (6MWT)

  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)

  Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

• Assisted-6 Minute Cycling Test (A6MWT)

  Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

Other Outcomes (4)

• NEPSY-II

  Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

• Endurance

  Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).

• User Engagement Scale-Short Form (UES-SF)

  Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).

Study Arms (1)

Two-phase arm

EXPERIMENTAL

* 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 for 20 minutes (plus 5-10 minutes of warm-up and 5-10 minutes of cool down).

Device: Dual-task cycling; Other: Standard therapy

Interventions

Standard therapy OTHER

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

Two-phase arm

Dual-task cycling DEVICE

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.

Two-phase arm

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato: lead
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• IRCCS Eugenio Medea: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• IRCCS Fondazione Stella Maris: collaborator

Study Sites (4)

IRCCS E. Medea - La Nostra Famiglia

Bosisio Parini, LC, 23849, Italy

Location

IRCCS Fondazione Stella Maris

Pisa, PI, 56128, Italy

Location

IRCCS Fondazione Mondino

Pavia, PV, 27100, Italy

Location

Fondazione Don Gnocchi - Centro "S. Maria al Mare"

Salerno, SA, 84131, Italy

Location

MeSH Terms

Conditions

Muscular Dystrophies; Myotonia Congenita; Neuromuscular Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Sara Arlati, Bioengineer

CONTACT

(+39)03412350202; sara.arlati@cnr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants first undergo 3 months of standard therapy, followed by 3 months of intervention with Virtual Park. They act as controls for themselves.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

IT (4)