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VirtualPark_Pediatric

7 augustus 2026 bijgewerkt door: Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

22

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Sara Arlati, Bioengineer
  • Telefoonnummer: (+39)03412350202
  • E-mail: sara.arlati@cnr.it

Studie Locaties

  • Italië
    • LC
      • Bosisio Parini, LC, Italië, 23849
    • PI
      • Pisa, PI, Italië, 56128
        • Werving
        • IRCCS Fondazione Stella Maris
        • Contact:
        • Hoofdonderzoeker:
          • Giada Sgherri
    • PV
      • Pavia, PV, Italië, 27100
    • SA
      • Salerno, SA, Italië, 84131
        • Geschorst
        • Fondazione Don Gnocchi - Centro "S. Maria al Mare"

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Two-phase arm
  • 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).
Apparaat: 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.
Ander: Standard therapy
Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Motor Function Measure-32 (MFM-32) - Total score
Tijdsspanne: 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.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
North Star Ambulatory Assessment (NSSA)
Tijdsspanne: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[FOR AMBULATORY PARTICIPANTS ONLY] The North Star Ambulatory Assessment (NSSA) scale was developed specifically for ambulatory children with dystrophinopathy starting at age 5 to obtain information on their motor and functional abilities. The instrument consists of 17 items scored from 0 to 2. The final score is the sum of the scores obtained for all items. Two timed tests are also recorded: the time to stand up from the ground and the time required to walk/run 10 meters.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Timed functional tests (TFTs)
Tijdsspanne: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[FOR AMBULATORY PARTICIPANTS ONLY] Timed functional tests (TFTs) are administered in a standardized manner to subjects with Duchenne muscular dystrophy to measure the time taken to perform the following four activities: moving from a supine to a standing position, walking/running for 10 meters, and ascending and descending a standardized 4-step staircase. The scoresheet records, in addition to the time taken to complete the task, a qualitative grading score from 1 to 6.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
6-Minute Walking Test (6MWT)
Tijdsspanne: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[FOR AMBULATORY PARTICIPANTS ONLY] The 6-Minute Walking Test (6MWT) was developed in the cardio-respiratory field but is now used across various fields of motor rehabilitation where it is necessary to quantify the patient's walking endurance. The test measures the distance a patient can cover, walking on a flat surface along a standardized path, in a period of 6 minutes [25]. In addition to the total distance covered, the distances covered for each minute are also collected and any falls/pauses are recorded.
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)
Tijdsspanne: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
[FOR NON-AMBULATORY PARTICIPANTS ONLY] The Performance Upper Limb Module 2.0 scale (PUL version 2.0) was developed to evaluate the motor performance of the upper limbs of subjects with dystrophinopathies from 5 years of age. This latest version of the instrument consists of an entry item useful for defining the patient's functional level and scored separately (from 0 to 6) and of 22 other items (scored from 0 to 2). The final score is made up of 2 values: the entry level score and the total score given by the sum of the scores obtained in the individual items [26].
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Assisted-6 Minute Cycling Test (A6MWT)
Tijdsspanne: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Performance change in the Assisted 6-minute cycling test (A6MCT). The A6MCT is a submaximal endurance test performed by pedaling with a cycle ergometer in passive mode for both upper and lower limbs, specifically created for subjects affected by Duchenne muscular dystrophy, both ambulatory and non-ambulatory. The final score records the number of complete revolutions performed in 6 minutes; the number of revolutions per minute and any breaks requested by the subject are also recorded [27].
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
NEPSY-II
Tijdsspanne: Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)

The NEPSY-II scale is a battery of tests that allows a neuropsychological evaluation of pediatric subjects, in relation to specific cognitive domains. It is composed of 33 tests that refer to 6 different cognitive domains (Attention and Executive Functions, Language, Memory and Learning, Sensorimotor Functions, Social Perception, Visuospatial Processing).

For the purposes of the study, the items "list memory" and "drawing memory" (Memory and Learning domain), the item "Inhibition" (Attention and Executive Functions domain) and the item "find the way" (Visuospatial Processing domain) are used.
Baseline (pre-treatment), 3 months (post-standard therapy, T1), 6 months (post-VirtualPark intervention, T2)
Endurance
Tijdsspanne: Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).
Measurement of heart rate (HR) and heart rate variability (HRV) collected with a wearable sensor (chest band), Movesense Medical (class IIa MDR 2017/745) or comparable medically certified device.
Continuously assessed during each training session from Month 3 (T1) to Month 6 (T2).
User Engagement Scale-Short Form (UES-SF)
Tijdsspanne: Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).
The User Engagement Scale-Short Form (UES-SF) questionnaire will be used to measure engagement. It is a self-report questionnaire, composed of 12 items rated on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). In particular, the UES-SF questionnaire investigates the following four factors: perceived usability, aesthetic appeal, focused attention, and reward. This questionnaire will be administered to the study participants in the Italian version, for which the scale has been translated and validated.
Every week (i.e., every 3 sessions) from Month 3 (T1) to Month 6 (T2).
Device safety
Tijdsspanne: From Month 3 (T1) to Month 6 (T2).
The number and description of any adverse events attributable to the use of the device are collected. Adverse events are monitored in accordance with MDR 2017/745, with events reported to responsible office of the Ministry of Health and the relevant Ethical Committee.
From Month 3 (T1) to Month 6 (T2).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

Medewerkers

IRCCS Eugenio Medea
IRCCS Fondazione Stella Maris
IRCCS National Neurological Institute "C. Mondino" Foundation
Fondazione Don Carlo Gnocchi ETS

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juni 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

12 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0057550-28/04/2026

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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