RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-21
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06027580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Study subjects aged 6 months to 18 months age corrected with abnormal muscle tone
  2. * No previous use of SPIO® or similar Lycra/compression garments
  3. * Assessed by provider as likely to benefit from use of compression garment
  1. * Non-English speaking
  2. * Inability for family to bring study subject to assessments
  3. * Orthosis or casting that contraindicate SPIO® Core-MAX® during the study period
  4. * Botulinum toxin injections within 3 months, or during study participation
  5. * Having prior orthopedic or neurosurgery surgeries within one year

Contacts and Locations

Study Contact

Mitchell O'Neill, MD
CONTACT
414-266-4771
moneill@mcw.edu
Meghann Sytsma
CONTACT
414-955-1922
mesytsma@mcw.edu

Principal Investigator

Mitchell O'Neill, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin/Children's Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Mitchell O'Neill, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-21
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-02-21
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • abnormal muscle tone
  • cerebral palsy
  • hypotonia
  • muscle tone
  • spasticity

Additional Relevant MeSH Terms

  • Cerebral Palsy