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Completed

NCT Number: NCT02996643

Ultrasound-Assisted Brace Casting for AIS

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine associated with vertebral rotation. Brace treatment is the most commonly used non-surgical treatment. To obtain the best possible outcome, the best in-brace correction within the patient's accepted tolerance must be provided. However, in the existing clinical practice, the immediate in-brace correction cannot be measured during the design and fitting of the brace because the correction is determined using a radiograph. This study is to evaluate the effect of applying ultrasound to measure the stimulated in-brace correction during brace casting.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medicine and Dentistry

Edmonton, Alberta, T6G2R7, Canada

About this study

Background: Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine associated with vertebral rotation. Brace treatment is the most commonly used non-surgical treatment. To obtain the best possible outcome, the best in-brace correction within the patient's accepted tolerance must be provided. However, in the existing clinical practice, the immediate in-brace correction cannot be measured during the design and fitting of the brace because the correction is determined using a radiograph.

Objectives: The objective of this study is to use ultrasound method to determine the optimum tolerable applied pressure level that can provide maximum in-brace correction.

Procedure:

Control Group: In the traditional method, each brace will be constructed using a plaster cast of the patient's trunk. Before the plaster cast hardens, the subject will lie on a casting board with multiple brace pads applied to correct the curve(s). The trim lines, pad placement, and areas of relief are then determined by the orthotist and guided by the curvature seen on the pre-brace PA spine radiograph.

Intervention Group: Before applying the plaster, subjects will lie on the custom designed frame. Two ultrasound scans will be performed and the average Cobb value will be used as the baseline. Multiple adjustable brace pads, each allowing for 6° of freedom and variable forces, will be applied to the patients' body according to orthotist suggestion. The apical brace pad that is used to control the major curve will be marked relative to the casting board as the reference location. The major pressure pad will be moved up 1 inch, then down 1 inch relative to the reference location. The 1 inch increment corresponds to the casting board, but finer adjustment is available. Two repeated ultrasound scans will be performed at each pad location (total 3 locations), and the average in-brace Cobb values will be estimated to determine optimum apical brace pad location. Next, pressure will be increased incrementally up to the tolerance level of the subject; this will be done by inflating the bladder at the apical brace pad. Another two ultrasound scans will then be performed to confirm that the maximum in-brace Cobb value is obtained. The orthotist will use this configuration to set the pad size and location once the plaster cast has been applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AIS patients who are prescribed braces to treat their spinal deformity.

Exclusion criteria

  • Any one does not want to participate.

Treatment and study plan

Ultrasound Assisted Group

Device

A custom brace standing frame, a medical ultrasound system, a custom pressure measurement system, and in-house Ultrasound measurement software were used to assist brace casting for the intervention group.

Primary outcomes

  1. In-brace Cobb angle

    Time frame: 6 weeks

    In-brace radiographs will be obtained after patients use their braces for 6 weeks

Secondary outcomes

  1. Number of adjustments

    Time frame: 6 weeks

    Check if brace adjustment is required

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Determine the Optimum Applied Pressure for the Brace Treatment of Scoliosis

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2016
Registry last updated
Dec 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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