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Ultrasound-Assisted Brace Casting for AIS

NCT ID: NCT02996643

Last Updated: 2016-12-19

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

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis; Adolescence

Keywords

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Adolescent Idiopathic Scoliosis Brace Treatment Ultrasound Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Traditional method

The traditional brace design method will be used to design a spinal brace.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

A custom Providence 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.

Group Type ACTIVE_COMPARATOR

Ultrasound Assisted Group

Intervention Type 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.

Interventions

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Ultrasound Assisted Group

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any one does not want to participate.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edmond Lou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Medicine and Dentistry

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Lou EH, Hill DL, Donauer A, Tilburn M, Hedden D, Moreau M. Results of ultrasound-assisted brace casting for adolescent idiopathic scoliosis. Scoliosis Spinal Disord. 2017 Aug 8;12:23. doi: 10.1186/s13013-017-0130-2. eCollection 2017.

Reference Type DERIVED
PMID: 28795156 (View on PubMed)

Other Identifiers

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Pro000028133

Identifier Type: -

Identifier Source: org_study_id