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

Medical College of Wisconsin30 enrolled

Overview

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.

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

Conditions

Cerebral Palsy

Interventions

SPIO® Core-MAX® Expedition thoracolumbosacral orthosisDEVICE

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis use 2 hours per day for 6 months

Standard Care Therapy optionOTHER

Standard of care Therapy without the use of trunk orthosis

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 Months

Medical Language ↔ Plain English

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

Locations (1)

Medical College of Wisconsin/Children's Wisconsin

Milwaukee, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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 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

Time frame: Through study completion, an average of 2 years

Central Contacts

Mitchell O'Neill, MD

CONTACT

414-266-4771 moneill@mcw.edu

Sarah Golus

CONTACT

414-955-1923 sgolus@mcw.edu

Data from ClinicalTrials.gov

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