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Orthosis to Improve Trunk Control in Infants Age 6-18 Months

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Feb 21, 2024 to Aug 6, 2026 Trial completed · Final enrollment: 21 participants (planned 30) · Eligibility criteria expanded, about 8 words · 1 more Show 4 more changesShow less
    • Trial completed
    • Final enrollment: 21 participants (planned 30)
    • Eligibility criteria expanded, about 8 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv6
  3. Primary completion date: Jun 30, 2025 to Aug 6, 2026 Completion date: Dec 31, 2025 to Aug 6, 2026 · Site contact updatedv5 Show 2 more changesShow less
    • Completion date: Dec 31, 2025 to Aug 6, 2026
    • Site contact updated
  4. Interventions: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis (Device) to SPIO® Core-MAX® Expedition thoracolumbosacral orthosis (Device), Standard Care Therapy option (Other) Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
  5. Primary completion date: Jun 2025 to Jun 30, 2025 Completion date: Dec 2025 to Dec 31, 2025 · Start date changed from estimate of Jan 2024 to Feb 21, 2024v3 Show 2 more changesShow less
    • Completion date: Dec 2025 to Dec 31, 2025
    • Start date changed from estimate of Jan 2024 to Feb 21, 2024
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.
Trial Details
NCT Number NCT06027580
Lead Sponsor Medical College of Wisconsin
Collaborators: SPIO
Conditions Cerebral Palsy
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov