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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Meghann Sytsma; Phone Number: 414-955-1922; Email: mesytsma@mcw.edu
• Study Contact Backup: Name: Stacy Stibb, DO; Phone Number: 414-266-2745; Email: sstibb@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin/Children's Wisconsin
      • Contact: Meghann Sytsma; Phone Number: 414-955-1922; Email: mesytsma@mcw.edu
      • Contact: Stacy Stibb, DO; Phone Number: 414-266-2745; Email: sstibb@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged 6 months to 18 months age corrected with abnormal muscle tone assessed by a provider as likely to benefit from use of a compression garment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis; SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months
Control group; Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: SPIO
• Investigators: Principal Investigator: Stacy Stibb, DO, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: spasticity; cerebral palsy; hypotonia; muscle tone; abnormal muscle tone
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: PRO00048530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No