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NCT02610855

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

Enrolling by Invitation
NAAges 9–16InterventionalTreatment
Mayo Clinic
~200 participants
Updated 2025-09-15 on ClinicalTrials.gov
What's tested:Spinal Fusion SurgeryBracingTri-axial AccelerometersShear Wave Elastography (SWUE)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in percentage of day with static activity
Measured over Baseline, 1 year
+1 more outcome measured

Conditions

Scoliosis

Explore related trials

Forearm FractureScoliosis

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Todd Milbrandt, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Males and females between 9 to16 years of age
Scoliosis/Surgery group; has severe scoliosis curves requiring posterior spinal fusion surgery
Scoliosis/Brace group; has scoliosis curves requiring brace treatment for at least the next year
The Control group will be aged matched participants who have healed forearm fractures and will be matched to case patients by age, gender, and Body Mass Index (BMI). These children will be considered normal subjects for both the accelerometers and the Shear Wave Elastography (SWUE)

What this trial measures

  • Change in percentage of day with static activityBaseline, 1 year

    Physical activity is measured by 4 wearable Tri-axial Accelerometers, worn for a 4 day period at baseline (prior to surgery or brace placement) and at one year after surgery of brace placement. Each second of data will be classified as static or dynamic. Among static postures, lying, standing and sitting are determined based on the orientation of the waist and thigh accelerometers in relation to the line of gravity. Accelerometer data from the 4 activity monitors are combined to provide a total percentage of time with static activities.

  • Change in dynamic physical activity as measured by step countsBaseline, 1 year

    Physical activity is measured by 4 wearable Tri-axial Accelerometers worn for a 4 day period at baseline (prior to surgery or brace placement) and at one year after surgery of brace placement. Each second of data will be classified as static or dynamic. Dynamic movements will be classified as walking, jogging or stair climbing based activity that exceeds the pre-defined accelerometer amplitude threshold. Step counts will be calculated based on detection of peak accelerations of the bilateral ankles using adaptive thresholds during the longest period of walking. Accelerometer data from the 4 activity monitors are combined to provide a total measure of dynamic physical activity.