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Procedure

Physical Activity Monitoring for Scoliosis (SAMUS SCOLI Trial)

N/A

Waitlist Available

Led By Todd Milbrandt, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how different levels of physical activity affect scoliosis patients with different levels of severity.

Who is the study for?

This trial is for boys and girls aged 9-16 with severe scoliosis needing spinal fusion surgery or brace treatment. A control group of similar age, gender, and BMI with healed forearm fractures will also participate to compare muscle function.

What is being tested?

The study examines how treatments like spinal fusion surgery and bracing affect muscle activity in young scoliosis patients using devices that measure movement (Tri-axial Accelerometers) and muscle stiffness (Shear Wave Elastography).

What are the potential side effects?

Potential side effects are not detailed but may include typical risks associated with surgical procedures such as pain, infection, bleeding, or reactions to anesthesia; bracing might cause discomfort or skin issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery for my severe scoliosis.

Select...

I need to wear a brace for my scoliosis for at least the next year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in dynamic physical activity as measured by step counts

Change in percentage of day with static activity

Secondary study objectives

Change in mean paraspinal muscle stiffness

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Control ArmExperimental Treatment2 Interventions

The control group are participants who do not have scoliosis. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified at baseline and one year after enrollment.

Group II: Brace TreatmentActive Control3 Interventions

The bracing participants have scoliosis curves that require treatment with a spinal brace for at least the next year. All braces will have monitors to record hours of brace wear, as is current standard of care. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before bracing and after one year.

Group III: Spinal Fusion SurgeryActive Control3 Interventions

The surgical participants recruited from the pediatric orthopaedic clinic and have severe scoliosis curves requiring posterior spinal fusion. Physical activity measured using Tri-axial accelerometers and paraspinal muscle stiffness measured by Shear Wave Elastography (SWUE) ultrasound will be quantified before and one year after spinal fusion surgery.

0 / 2Eligibility criteria met