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Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

Study acronym: Agilik@home
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jul 2026 to Nov 2026v5
  2. Site details revised at 3 of 6 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Oct 29, 2024
    • Site details revised at 6 of 6 sites
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are: Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy. Participants will: Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.
Trial Details
NCT Number NCT06622655
Lead Sponsor IRCCS Eugenio Medea
Collaborators: IRCCS Fondazione Stella Maris, Fondazione Don Carlo Gnocchi ETS, IRCCS National Neurological Institute "C. Mondino" Foundation
Conditions
(from sponsor)		 Cerebral Palsy (CP)
Related terms Cerebral Palsy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov