Recruiting

Orthosis

Sponsor:

Medical College of Wisconsin

Code:

NCT06027580

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Standard Care Therapy option

Study Details

Brief 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

Study ID

NCT06027580

Start date

Feb 21, 2024

Status verified date

Jan, 2026

Completion date

Aug 6, 2026

Anticipated

Primary completion date

Aug 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Control group

Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone

Interventions

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

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

Standard Care Therapy option

Standard of care Therapy without the use of trunk orthosis

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 ]
  • Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale. [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Mitchell O'Neill, MD

414-266-4771moneill@mcw.edu

Sarah Golus

414-955-1923sgolus@mcw.edu

Locations

Medical College of Wisconsin/Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Mitchell O'Neill, MD

414-266-4771moneill@mcw.edu

Sarah Golus

414-955-1923sgolus@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • abnormal muscle tone
  • cerebral palsy
  • hypotonia
  • muscle tone
  • spasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-14.