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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06027580
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
6 Months - 18 Months
Healthy Volunteers
Not accepted

Interventions

  • SPIO® Core-MAX® Expedition thoracolumbosacral orthosis — DEVICE
    SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
  • Standard Care Therapy option — OTHER
    Standard of care Therapy without the use of trunk orthosis

Study Details

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.

Key Dates

Start date
Feb 21, 2024
Status verified
Jan 2026
Primary completion
Aug 6, 2026
Completion
Aug 6, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: SPIO group
    Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis
  • Arm: Control group
    Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone

Primary Outcome Measure

Change in head and trunk position from centerline at baseline, 3-months and 6-months. [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of Wisconsin/Children's WisconsinMilwaukeeWisconsin53226
Mitchell O'Neill, MD
[email protected]
414-266-4771
Sarah Golus
[email protected]
414-955-1923

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By research site
Medical College of Wisconsin/Children's Wisconsin· Milwaukee, WI

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