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

NCT06027580 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-01-14

No results posted yet for this study

Summary

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.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months

OTHER

Standard Care Therapy option

Standard of care Therapy without the use of trunk orthosis

Sponsors & Collaborators

  • SPIO

    collaborator UNKNOWN

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Mitchell O'Neill, MD · Medical College of Wisconsin

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2026-08-06
Completion
2026-08-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027580 on ClinicalTrials.gov