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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027580
• Other study ID #: PRO00048530
• Status: Recruiting
• Start date: February 21, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: Stacy Stibb, DO
• Phone: 414-266-2745
• Email: sstibb[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin/Children's Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	SPIO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in head and trunk position from centerline at baseline, 3-months and 6-months.	Degree change in head and trunk position from centerline as assessed by motion capture.	Through study completion, an average of 2 years
Primary	Change from baseline to 3-months and 6-months on the Pediatric Quality of Life Inventory Infant Scale.	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; if it is almost never a problem; if it is sometimes a problem; if it is often a problem; if it is almost always a problem	Through study completion, an average of 2 years