NCT06027580

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

Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-21
• Primary completion: 2026-08-06
• Completion: 2026-08-06
• First posted: 2023-09-07
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States