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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

SAMUS SCOLI Trial 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.Check my eligibility
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).See study design
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.

SAMUS SCOLI Trial 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.

SAMUS SCOLI Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in dynamic physical activity as measured by step counts
Change in percentage of day with static activity
Secondary outcome measures
Change in mean paraspinal muscle stiffness

SAMUS SCOLI 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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,940 Total Patients Enrolled
7 Trials studying Scoliosis
5,470 Patients Enrolled for Scoliosis
Todd Milbrandt, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project only enrolling individuals who are 20 years or older?

"Participants that are 9 years or older, but younger than 16 years old may take part in this study."

Answered by AI

Which patients fit the inclusion criteria for this trial?

"Eligibility requirements for this trial include a diagnosis of scoliosis and being between 9-16 years old. A maximum of 200 patients will be accepted into the study."

Answered by AI

Are there any available openings for participants in this research?

"According to the latest information on clinicaltrials.gov, this study is no longer recruiting patients. The trial was first posted on November 1st, 2015 and ended recruitment on September 28th, 2020; however, there are 79 other trials with open enrollment at the moment."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis
Todd A. Milbrandt, M.D. 2015. "Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02610855.
All > Scoliosis
~6 spots leftby Aug 2024
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