Ultrasound-Assisted Brace Casting for AIS

Determine the Optimum Applied Pressure for the Brace Treatment of Scoliosis

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Adolescence
• Intervention / Treatment: Device: Ultrasound Assisted Group

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2R7
      • Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any one does not want to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Traditional method; The traditional brace design method will be used to design a spinal brace.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-brace Cobb angle	In-brace radiographs will be obtained after patients use their braces for 6 weeks	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adjustments	Check if brace adjustment is required	6 weeks

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Edmond Lou, PhD, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Estimate): December 19, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound Imaging; Adolescent Idiopathic Scoliosis; Brace Treatment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: Pro000028133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No