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El ensayo clínico NCT07434492 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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Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy Fase II 60 En casa Aleatorizado
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 NCT07434492 está diseñado para estudiar otros de Parálisis cerebral. Este es un estudio intervencionista de Fase II. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de marzo de 2026 hasta completar 60 participantes. Dirigido por Shirley Ryan AbilityLab, se espera que finalice el 31 de agosto de 2030. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de febrero de 2026.
Resumen
This is an intervention study to investigate the impact of a smart ankle-foot orthosis (AFO) on mobility outcomes in children with Cerebral Palsy. Participants will complete a three phase protocol including 6-weeks of at home training with the smart AFO. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the smart AFO to further...Mostrar más
Descripción detallada
The goal of this project is to investigate the impact of the Biomotum Ambulo ankle-foot orthosis on gait outcomes in children with Cerebral Palsy. The device will be tested for its orthotic benefits when providing mechanical ankle assistance and its therapeutic benefits when providing progressive, resistance-based ankle exercise. Through a 1:1 randomization, a subset of opt-in participants will also receive a dose of...Mostrar más
Título oficial
Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy
Condiciones médicas
Parálisis cerebralOtros ID del estudio
- STU00225131
Número del NCT
Inicio del estudio (real)
2026-03-01
Última actualización
2026-02-25
Fecha de finalización (estimada)
2030-08-31
Inscripción (prevista)
60
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Aún no recluta
Palabras clave
Pediatric
Objetivo principal
Otros
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Triple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalSmart AFO & Home Intervention Training + 5-Azacitidine Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.
Each session will involve:
1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT)
2. Monito...Mostrar más | Smart Ankle-Foot Orthosis The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait. 5-Azacitidine A subset of opt-in participants will receive a single dose (75mg/m²) of 5-Azacitidine (AZA), an FDA-approved drug for pediatric oncology. A registered nurse will deliver a single subcutaneous injection at midpoint. |
Comparador activoSmart AFO & Home Intervention Training + Mannitol (Placebo) Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.
Each session will involve:
1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT)
2. Monito...Mostrar más | Smart Ankle-Foot Orthosis The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait. PLACEBO A subset of opt in participants will receive a single dose (75mg/m²) of Mannitol (placebo). A registered nurse will deliver a single subcutaneous injection at midpoint. |
Comparador activoSmart AFO & Home Intervention Training Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.
Each session will involve:
1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7/10 on the Pictorial Children's Effort Rating Table (PCERT)
2. Monito...Mostrar más | Smart Ankle-Foot Orthosis The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
6 Minute Walking Test | Participants will complete a 6 minute walking test to measure the total distance they can walk in a 6 minute period. | Baseline to Follow-Up, approximately 13 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
10 Meter Walking Test | Participants will walk 10 meters to assess gait speed. | Baseline to Follow-Up, approximately 13 weeks |
Gross Motor Function Measure 88 (GMFM-88) | GMFM-88 will be used to measure changes in gross motor function over time. | Baseline to Follow-Up, approximately 13 weeks |
Selective Control Assessment of the Lower Extremity (SCALE) | The SCALE is a clinical assessment tool used to evaluate selective voluntary motor control of the lower limbs. | Baseline to Post-Intervention, approximately 7 weeks |
Pediatric Berg Balance Scale (BBS) | The Pediatric BBS will be used to assess static balance and fall risk. | Baseline to Follow-Up, approximately 13 weeks |
Modified Tardieu Scale (MTS) | Modified Tardieu Scale will be completed to assess the muscle's response to stretch at given velocities. | Baseline to Follow-Up, approximately 13 weeks |
Cerebral Palsy Questionnaire (CPCHILD) | CPCHILD will be administered to capture the child's and family's perspective on well-being and participation. | Baseline to Follow-Up, approximately 13 weeks |
Wong-Baker FACES Pain Rating Scale | The Wong-Baker FACES Pain Rating Scale will be used for children to self-report their level of pain. | Baseline to Follow-Up, approximately 13 weeks |
Pictorial Children's Effort Rating Table (PCERT) | The PCERT will be used for children to self-assess and communicate their perceived exertion during physical activity or exercise. | Baseline to Follow-Up, approximately 13 weeks |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño
Edad mínima
8 Years
Criterios de sexo
Todos
- Diagnosis of cerebral palsy classified as Gross Motor Function Classification System (GMFCS) levels I to III
- Between 8 and 17 years and 8 months of age at the time of enrollment/consent. Participants that will turn 18 during the course of the study will not be included as pausing the at-home protocol until re-consenting is possible could interfere with intervention results.
- Stable medical condition as determined by the investigator.
- Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the PI.
- Height/weight/BMI between the 5th - 95th percentile of children with cerebral palsy
- Able to walk for at least 6 minutes (assisted or unassisted)
- Able to understand and follow simple directions
- Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
- At least 20 degrees of passive ankle plantar flexion range of motion
- Physician approval for participation
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees
- Immunodeficiency or hematologic condition
- Allergy to AZA or mannitol
- Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5
- Pregnancy
- Orthopedic surgery on the lower limbs completed in the prior 12 months
- New implanted device (e.g., baclofen pump) and/or active intrathecal medication titration that may affect muscle spasticity
- Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the study physician
- Severe osteoporosis unless given approval by the study physician
- Current enrollment in a conflicting research study
- Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician
Shirley Ryan AbilityLabParte responsable del estudio
Megan O'Brien, Investigador principal, Associate Director, Technology & Innovation, Shirley Ryan AbilityLab
Contactos centrales del estudio
Contacto: Audrey Wiesner, BS, 3122388435, [email protected]
Contacto: Jacklyn Stoller, PT, DPT, 3122387620, [email protected]
1 Centros del estudio en 1 países
Illinois
Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States