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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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The aims include first, to quantify the posture and physical activity of patients in the community before and after scoliosis treatment and compare to age-matched controls. Patients undergoing bracing or surgery for scoliosis will wear novel low-profile electronic monitors for 4 days prior to and at one year after initiation of treatment. Accelerometer data from the 4 activity monitors are combined for a comprehensive profile of daily activity, above and beyond that of a typical pedometer. Analysis will show a participant's % active time vs. static, % time sitting vs. lying down vs. standing vs. walking, total number of steps taken per day, and cadence of walking during each activity bout. The amount of total daily time spent lying, sitting, standing, walking and running will be quantified using specialized processing algorithms developed at Mayo Clinic. Results will be compared to a group of age- and BMI-matched control patients with healed forearm fractures.

Second, to determine changes in the mechanical properties of the paraspinal skeletal musculature (muscles along the spine) in scoliosis patient before and after treatment with brace or spinal surgery.

Shear Wave Elastography (SWUE) is a technique that uses ultrasound, a non-invasive imaging technique, to detect mechanical properties of tissues. Using SWUE, the stiffness in the paraspinal muscles will be obtained by acquiring Shear modulus measurements, reported in kilo Pascal (kPa) units. 10 measurements will be obtained for each muscle and a region of interest (ROI) will be placed in the displayed elastogram or color map from each measurement to obtain a "kPa" value. A mean shear modulus or stiffness will be obtained by averaging all 10 results. The measurements from each ROI are derived using software built in the ultrasound equipment.

The change in paraspinal skeletal muscle stiffness will be assessed and compared to normal controls to determine characteristics of spinal musculature in scoliosis patients and the impact of treatment with bracing or surgery.

Conditions

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Scoliosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal Fusion Surgery

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.

Group Type ACTIVE_COMPARATOR

Spinal Fusion Surgery

Intervention Type PROCEDURE

Participants with severe scoliosis curves requiring spinal fusion surgery.

Tri-axial Accelerometers

Intervention Type DEVICE

Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.

Shear Wave Elastography (SWUE)

Intervention Type OTHER

SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.

Brace Treatment

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 Type ACTIVE_COMPARATOR

Bracing

Intervention Type OTHER

Participants with scoliosis curves that require brace treatment for at least the next year. Braces include monitors to record hours of brace wear, as is current standard of care.

Tri-axial Accelerometers

Intervention Type DEVICE

Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.

Shear Wave Elastography (SWUE)

Intervention Type OTHER

SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.

Control Arm

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 Type OTHER

Tri-axial Accelerometers

Intervention Type DEVICE

Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.

Shear Wave Elastography (SWUE)

Intervention Type OTHER

SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.

Interventions

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Spinal Fusion Surgery

Participants with severe scoliosis curves requiring spinal fusion surgery.

Intervention Type PROCEDURE

Bracing

Participants with scoliosis curves that require brace treatment for at least the next year. Braces include monitors to record hours of brace wear, as is current standard of care.

Intervention Type OTHER

Tri-axial Accelerometers

Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.

Intervention Type DEVICE

Shear Wave Elastography (SWUE)

SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.

Intervention Type OTHER

Other Intervention Names

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ActiGraph GT3X+

Eligibility Criteria

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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)