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

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

• Registration Number: NCT06027580
• Lead Sponsor: Medical College of Wisconsin

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.

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.

Study Timeline

• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Study Start: 2024-02-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SPIO group	SPIO® Core-MAX® Expedition thoracolumbosacral orthosis	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

Primary Outcome Measures

Name	Time	Method
Change in head and trunk position from centerline at baseline, 3-months and 6-months.	Through study completion, an average of 2 years	Degree change in head and trunk position from centerline as assessed by motion capture.
Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.	Through study completion, an average of 2 years	The Pediatric Quality of Life Inventory Infant Scales (PedQL-I) is used to assess parent-reported health-related quality of life for children with ages 1-12 months or 12-24 months. It has the same five components, including physical functioning (6 items), physical symptoms (10 items), emotional functions (12 items), social functioning (4 items), and cognitive functioning (4 items) with scale from 0 to 4.; 0 if it is never a problem; 1. if it is almost never a problem; 2. if it is sometimes a problem; 3. if it is often a problem; 4. if it is almost always a problem

Trial Locations

Locations (1)

Medical College of Wisconsin/Children's Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States