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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Scoliosis
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.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER