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Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy Phase II 60 À domicile Randomisé

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07434492 est conçu pour étudier Autre de Paralysie cérébrale. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mars 2026, avec un objectif de 60 participants. Dirigée par Shirley Ryan AbilityLab, l'étude devrait être terminée d'ici le 31 août 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 25 février 2026.
Résumé succinct
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...Afficher plus
Description détaillée
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...Afficher plus
Titre officiel

Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy

Pathologies
Paralysie cérébrale
Autres identifiants de l'étude
  • STU00225131
Numéro NCT
NCT07434492
Date de début (réel)
2026-03-01
Dernière mise à jour publiée
2026-02-25
Date de fin (estimée)
2030-08-31
Inscription (estimée)
60
Type d'étude
Interventionnel
PHASE
Phase II
Statut
Pas encore en recrutement
Mots clés
Pediatric
Objectif principal
Autre
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalSmart 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...Afficher plus
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.
Comparateur actifSmart 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...Afficher plus
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.
Comparateur actifSmart 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...Afficher plus
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.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant
Âge minimum
8 Years
Sexes éligibles
Tous
  • 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 AbilityLab logoShirley Ryan AbilityLab
Partie responsable de l'étude
Megan O'Brien, Investigateur principal, Associate Director, Technology & Innovation, Shirley Ryan AbilityLab
Contact central de l'étude
Contact: Audrey Wiesner, BS, 3122388435, [email protected]
Contact: Jacklyn Stoller, PT, DPT, 3122387620, [email protected]
1 Centres de l'étude dans 1 pays

Illinois

Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States