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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 9 Years - 16 Years
Gender All
More Inclusion & Exclusion Criteria

Three groups will be recruited from patients seen at the Mayo Clinic pediatric orthopedic clinic located in Rochester, Minnesota. Three groups with 12 patients in each group for a total of 36 patients, to allow for drop-outs and testing of statistical significance between the three cohorts (Brace, Surgery and Control groups).

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02610855
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Todd Milbrandt, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Scoliosis
Study Website: View Trial Website
Additional Details

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.#46; static, % time sitting vs.#46; lying down vs.#46; standing vs.#46; 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.

Arms & Interventions

Arms

Active Comparator: 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.

Active Comparator: 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.

Other: 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.

Interventions

Procedure: - Spinal Fusion Surgery

Participants with severe scoliosis curves requiring spinal fusion surgery.

Other: - 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.

Device: - 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.

Other: - 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.

Contact a Trial Team

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Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905