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El ensayo clínico NCT07061275 para Parálisis cerebral está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Telehealth-Supervised Resistance Training for Children With Cerebral Palsy 50 Telesalud Pediátrico
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07061275 es un estudio intervencionista para Parálisis cerebral. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de enero de 2026 hasta completar 50 participantes. Dirigido por Hunan Normal University, se espera que finalice el 1 de marzo de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 15 de septiembre de 2025.
Resumen
The goal of this clinical trial is to evaluate the feasibility and potential benefits of telehealth-supervised resistance training in ambulatory children aged 6 to 15 years with cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) levels I-III.
The main questions it aims to answer are:
- Is a 12-week telehealth-delivered resistance training program feasible and acceptable for childre...
Descripción detallada
Cerebral palsy (CP) is a lifelong neurodevelopmental disorder caused by non-progressive disturbances in the developing fetal or infant brain. It is characterized by impairments in movement and posture, often accompanied by disturbances in sensation, perception, cognition, communication, and behavior. Globally, CP affects an estimated 17 million individuals, with a birth prevalence of approximately 2 to 2.5 per 1,000 ...Mostrar más
Título oficial
Telehealth-Supervised Resistance Training to Improve Functional Capacity and Muscle Strength in Children With Cerebral Palsy: Protocol for a Single-Arm Intervention Study
Condiciones médicas
Parálisis cerebralOtros ID del estudio
- HunanNU-2025-506
Número del NCT
Inicio del estudio (real)
2026-01-01
Última actualización
2025-09-15
Fecha de finalización (estimada)
2027-03-01
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
balance
cost
exercise training
gait
group exercise
rehabilitation
strength training
cost
exercise training
gait
group exercise
rehabilitation
strength training
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalTelehealth-Supervised Resistance Training The intervention consists of a 12-week telehealth-supervised resistance training program designed for children with mild CP. Training sessions will be conducted live via a secure smartphone-based streaming platform three times per week, with each session lasting approximately 40 minutes. Each session includes a 5-minute warm-up, 30 minutes of structured exercises, and a 5-minute cool-down period. Sessions are schedul...Mostrar más | Telehealth-Supervised Resistance Training The exercise protocol will incorporate a variety of exercise modalities adapted for home use in limited space environments. Elastic resistance bands will be used for lower-limb strength exercises such as leg presses, hip abduction, and ankle dorsiflexion, while sandbag-style leg weights will be employed for activities including knee extensions, seated marches, and standing squats. To target balance, low-cost tools su...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
1-minute walk test | Participants will be instructed to walk as far as possible without running within one minute, and the total distance covered will be recorded. | Baseline (week 0) and post-intervention (week 12) |
10-meter walk test | Participants will be asked to walk as fast as possible for 10 meters. The test will be performed under two conditions - self-selected and fast walking speeds - with the average of three trials recorded per condition. | Baseline (week 0) and post-intervention (week 12) |
Lower-limb muscle strength | Lower-limb muscle strength will be assessed using the 30-second sit-to-stand test (30s STS), a simple, reliable functional test in which children are instructed to complete as many full STS repetitions as possible from a standard chair within 30 seconds (Romin et al., 2024). | Baseline (week 0) and post-intervention (week 12) |
Balance | Balance will be measured using the Pediatric Balance Scale, a 14-item assessment adapted from the Berg Balance Scale that evaluates functional postural control and is validated for ambulatory children with CP (Her et al., 2012). Tasks include standing on one foot, turning in place, and reaching forward | Baseline (week 0) and post-intervention (week 12) |
Pediatric Quality of Life Inventory | To assess life satisfaction and psychosocial well-being, children and their caregivers will complete the Pediatric Quality of Life Inventory™ (PedsQL) - Cerebral Palsy Module (Varni et al., 2006). This validated instrument measures multiple domains, including physical functioning, emotional well-being, and social participation. Both self-report and parent-proxy formats will be utilized for children aged 5-18 years. | Baseline (week 0) and post-intervention (week 12) |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
cost-acceptability survey | Caregivers will complete a cost-acceptability survey designed to assess the perceived affordability and feasibility of the telehealth-delivered training model. The survey will include statements such as "The program is affordable for my family," "10 CNY per session is a fair price for the quality of the program," and "I would continue the training even if not reimbursed," rated on a 5-point Likert scale from strongly agree to strongly disagree. Caregivers will also answer an open-ended question: "What is the maximum price you would be willing to pay per session?" These items aim to evaluate the scalability and economic sustainability of this intervention from the perspective of end users. | Post-intervention (week 12) |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño
Edad mínima
6 Years
Criterios de sexo
Todos
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS levels I, II, or III;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
- Aged under 6 years or over 15 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
Hunan Normal UniversityShanghai University of SportParte responsable del estudio
Yang Zhang, Investigador principal, Principle scientist, Hunan Normal University
Contactos centrales del estudio
Contacto: Yang Zhang, PhD, 7272559368, [email protected]
Contacto: Dinghua Liu, MS, 8618807486231, [email protected]
Sitio no especificado.