NCT06027580 · Medical College of Wisconsin
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Change in head and trunk position from centerline at baseline, 3-months and 6-months.
Time frame: 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.
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Milwaukee, Wisconsin
Collaborators
SPIO
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 14, 2026 · Source of record for eligibility and locations