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ENROLLING BY INVITATION
NCT02610855
NA

Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

This study will explore the relationship between skeletal muscle and physical activity in scoliosis patients to provide insight into both the etiology of scoliosis and potential ways to mitigate the potential harms of treatment.

Official title: Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis (SAMUS SCOLI)

Key Details

Gender

All

Age Range

9 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2015-11

Completion Date

2026-08

Last Updated

2025-09-15

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Spinal Fusion Surgery

Participants with severe scoliosis curves requiring spinal fusion surgery.

OTHER

Bracing

Participants with scoliosis curves that require brace treatment for at least the next year. Braces include monitors to record hours of brace wear, as is current standard of care.

DEVICE

Tri-axial Accelerometers

Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.

OTHER

Shear Wave Elastography (SWUE)

SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States