Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 1
Healthy Volunteers: f
View:
• 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
Locations
United States
Wisconsin
Medical College of Wisconsin/Children's Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Mitchell O'Neill, MD
moneill@mcw.edu
414-266-4771
Backup
Meghann Sytsma
mesytsma@mcw.edu
414-955-1922
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: SPIO
Leads: Medical College of Wisconsin