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VirtualPark_Pediatric

7 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

22

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sara Arlati, Bioengineer
  • Número de teléfono: (+39)03412350202
  • Correo electrónico: sara.arlati@cnr.it

Ubicaciones de estudio

  • Italia
    • LC
      • Bosisio Parini, LC, Italia, 23849
        • Reclutamiento
        • IRCCS E. Medea - La Nostra Famiglia
        • Investigador principal:
          • Eleonora Diella
        • Contacto:
    • PI
      • Pisa, PI, Italia, 56128
        • Reclutamiento
        • IRCCS Fondazione Stella Maris
        • Contacto:
        • Investigador principal:
          • Giada Sgherri
    • PV
      • Pavia, PV, Italia, 27100
        • Reclutamiento
        • IRCCS Fondazione Mondino
        • Contacto:
        • Investigador principal:
          • Angela Berardinelli
    • SA
      • Salerno, SA, Italia, 84131
        • Suspendido
        • Fondazione Don Gnocchi - Centro "S. Maria al Mare"

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).
Dispositivo: 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.
Otro: Standard therapy
Participants undergo their standard plan: outpatient treatment, if planned, or no treatment.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Motor Function Measure-32 (MFM-32) - Total score
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
North Star Ambulatory Assessment (NSSA)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
NEPSY-II
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

Colaboradores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de junio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de agosto de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0057550-28/04/2026

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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