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

Medical College of Wisconsin

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: Standard Care Therapy option; Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Study type: Observational

Funder types: Other

Identifiers

NCT06027580

PRO00048530

Details and patient eligibility

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

SPIO group

Description:

Standard Care Therapy option 1: parents may self-select this standard care combined option of therapy and use of SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Treatment:

Device: SPIO® Core-MAX® Expedition thoracolumbosacral orthosis

Control group

Description:

Standard Care Therapy option 2: parents may self-select this standard care option of therapy alone

Treatment:

Other: Standard Care Therapy option