Using a special orthosis to help infants with trunk control
Assessing Functional Improvements With Use of the SPIO Core-Max Expedition TLSO
This study is testing if a special support device can help babies with cerebral palsy improve their head, trunk, and arm movements better than just regular therapy alone.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 6 Months to 18 Months |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06027580 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the SPIO® Core-MAX® Expedition orthosis in improving head, trunk, and upper limb function in infants aged 6 to 18 months with abnormal muscle tone due to cerebral palsy. Families will choose between standard therapy or therapy combined with the orthosis, and outcomes will be assessed at baseline, 3 months, and 6 months. The study will compare the functional improvements between the two groups to determine the impact of the orthosis on motor skills.
Who should consider this trial
Good fit: Ideal candidates are infants aged 6 to 18 months with abnormal muscle tone who have not previously used similar orthotic garments.
Not a fit: Patients who have had recent orthopedic or neurosurgery or those who are non-English speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance trunk control and overall motor function in infants with cerebral palsy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using orthotic devices for improving motor function in children with cerebral palsy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin/Children's Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Mitchell O'Neill, MD — Medical College of Wisconsin
- Study coordinator: Mitchell O'Neill, MD
- Email: moneill@mcw.edu
- Phone: 414-266-4771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.