Scoliosis Clinical Trial
— SAMUS SCOLIOfficial title:
Effect of Treatment on Activity and Muscle Function in Pediatric Patients With Scoliosis (SAMUS SCOLI)
Verified date | October 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 16 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - Patients with underlying muscle conditions or neuromuscular scoliosis |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in percentage of day with static activity | 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. | Baseline, 1 year | |
Primary | Change in dynamic physical activity as measured by step counts | 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. | Baseline, 1 year | |
Secondary | Change in mean paraspinal muscle stiffness | Muscle stiffness is measured by Shear Wave Elastography (SWUE). This measurement evaluates normal muscle's passive and active properties at a variety of angles and tensions, resulting in a shear modulus reading, measured in average kilo Pascal units from 10 images of each muscle region of interest. A transducer is used with ultrasound to produce shear waves in tissue. The wave speed relates to the tissue's mechanical properties and is used to create a quantitative 2D elastogram of the tissue. Multiple shear modulus measurements will be averaged, and obtained:
on control subjects at the left and right sides of the T12 spine segment level on the scoliosis patients, at the periapical area (apex of curve, where it is most tilted) at the concave and convex sides as well as at an area remote from the curvature |
Baseline, 1 year |
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