200 Participants Needed

Physical Activity Monitoring for Scoliosis

(SAMUS SCOLI Trial)

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is physical activity monitoring for scoliosis safe for humans?

The research indicates that both bracing and spinal fusion surgery for scoliosis are generally safe, with no significant differences in function, pain, self-image, and mental health reported. However, bracing may lead to reduced physical activity, so patients should be encouraged to maintain recommended activity levels.12345

How does spinal fusion surgery differ from other treatments for scoliosis?

Spinal fusion surgery for scoliosis is unique because it involves permanently connecting two or more vertebrae in the spine to correct curvature, unlike bracing which is non-surgical and aims to prevent further curvature. This surgery can improve physical activity levels over time, as shown by increased steps and distance walked post-surgery, whereas bracing may lead to reduced physical activity.13678

What data supports the effectiveness of the treatment for scoliosis?

Research shows that spinal fusion surgery can improve trunk movement and satisfaction in patients with scoliosis, although it may not significantly change physical activity levels. Bracing, on the other hand, may reduce physical activity, but both treatments lead to improved satisfaction.134910

Who Is on the Research Team?

TM

Todd Milbrandt, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a child with a healed forearm fracture, matched in age, gender, and BMI with the case patients.
I am between 9 and 16 years old.
I need surgery for my severe scoliosis.
See 1 more

Exclusion Criteria

Patients with underlying muscle conditions or neuromuscular scoliosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Physical activity and paraspinal muscle stiffness are measured using Tri-axial accelerometers and Shear Wave Elastography before treatment

4 days
1 visit (in-person)

Treatment

Participants undergo bracing or spinal fusion surgery for scoliosis treatment

1 year

Follow-up Assessment

Physical activity and paraspinal muscle stiffness are re-evaluated using Tri-axial accelerometers and Shear Wave Elastography one year after treatment

4 days
1 visit (in-person)

Follow-up

Participants are monitored for changes in physical activity and muscle function after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bracing
  • Shear Wave Elastography (SWUE)
  • Spinal Fusion Surgery
  • Tri-axial Accelerometers
Trial Overview 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).
How Is the Trial Designed?
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.

Spinal Fusion Surgery is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tymlos for:
  • Osteoporosis in postmenopausal women at high risk of fracture
  • Increase bone density in men with osteoporosis
🇪🇺
Approved in European Union as Eladynos for:
  • Osteoporosis in postmenopausal women at increased risk of fracture

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Do Growing Rods for Idiopathic Early Onset Scoliosis Improve Activity and Participation for Children? [2018]
Prospective comparison of gait and trunk range of motion in adolescents with idiopathic thoracic scoliosis undergoing anterior or posterior spinal fusion. [2016]
Does the lower instrumented vertebra have an effect on lumbar mobility, subjective perception of trunk flexibility, and quality of life in patients with idiopathic scoliosis treated by spinal fusion? [2022]
Outcome of bracing vs. surgical treatment in adolescents with idiopathic scoliosis based on device measured daily physical activity: a prospective pilot study. [2023]
Asymmetrical trunk movement during walking improved to normal range at 3 months after corrective posterior spinal fusion in adolescent idiopathic scoliosis. [2018]
Early dynamic changes within the spine following posterior fusion using hybrid instrumentation in adolescents with idiopathic scoliosis: a gait analysis study. [2022]
mHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study. [2021]
Long-Term Objective Physical Activity Measurements using a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody Fusion Surgery. [2020]
Long-term impact of pre-operative physical rehabilitation protocol on the 6-min walk test of patients with adolescent idiopathic scoliosis: A randomized clinical trial. [2022]
Objective activity tracking in spine surgery: a prospective feasibility study with a low-cost consumer grade wearable accelerometer. [2021]
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