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NCT Number: NCT06027580

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

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.

Recruiting

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Muscle Hypertonia Muscle Hypotonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Device

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

Standard Care Therapy option

Other

Standard of care Therapy without the use of trunk orthosis

Primary outcomes

  1. 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.

  2. 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

    • if it is almost never a problem
    • if it is sometimes a problem
    • if it is often a problem
    • if it is almost always a problem

Study contacts

Contact information is provided by the study sponsor or research team.

Mitchell O'Neill, MD

CONTACT

[email protected]

414-266-4771

Sarah Golus

CONTACT

[email protected]

414-955-1923

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • SPIO

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 7, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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