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

Last updated: November 22, 2024
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Standard Care Therapy option

Clinical Study ID

NCT06027580
PRO00048530
  • Ages 6-18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone

  • No previous use of SPIO® or similar Lycra/compression garments

  • Assessed by provider as likely to benefit from use of compression garment

Exclusion

Exclusion Criteria:

  • Non-English speaking

  • Inability for family to bring study subject to assessments

  • Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period

  • Botulinum toxin injections within 3 months, or during study participation

  • Having prior orthopedic or neurosurgery surgeries within one year

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
Phase:
Study Start date:
February 21, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This study will observe the difference in outcomes between two courses of standard clinical care: therapy or therapy with the SPIO® Core-MAX® Expedition orthosis. Families will self-select that standard care option that works best for their family, and outcomes will be observed at baseline, 3 months and 6 months.

Connect with a study center

  • Medical College of Wisconsin/Children's Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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