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Ultrasound-Assisted Brace Casting for AIS

Primary Purpose

Scoliosis; Adolescence

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound Assisted Group
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Scoliosis; Adolescence focused on measuring Adolescent Idiopathic Scoliosis, Brace Treatment, Ultrasound Imaging

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Any one does not want to participate.

Sites / Locations

  • Medicine and Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Traditional method

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of adjustments
Check if brace adjustment is required

Full Information

First Posted
December 9, 2016
Last Updated
December 14, 2016
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT02996643
Brief Title
Ultrasound-Assisted Brace Casting for AIS
Official Title
Determine the Optimum Applied Pressure for the Brace Treatment of Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence
Keywords
Adolescent Idiopathic Scoliosis, Brace Treatment, Ultrasound Imaging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional method
Arm Type
No Intervention
Arm Description
The traditional brace design method will be used to design a spinal brace.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound Assisted Group
Intervention Description
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 Outcome Measure Information:
Title
In-brace Cobb angle
Description
In-brace radiographs will be obtained after patients use their braces for 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of adjustments
Description
Check if brace adjustment is required
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AIS patients who are prescribed braces to treat their spinal deformity. Exclusion Criteria: Any one does not want to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmond Lou, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine and Dentistry
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2R7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28795156
Citation
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.
Results Reference
derived

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Ultrasound-Assisted Brace Casting for AIS

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