Ultrasound-Assisted Brace Casting for AIS
Determine the Optimum Applied Pressure for the Brace Treatment of Scoliosis
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2012
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 19, 2016
CompletedDecember 19, 2016
December 1, 2016
4.2 years
December 9, 2016
December 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-brace Cobb angle
In-brace radiographs will be obtained after patients use their braces for 6 weeks
6 weeks
Secondary Outcomes (1)
Number of adjustments
6 weeks
Study Arms (2)
Traditional method
NO INTERVENTIONThe traditional brace design method will be used to design a spinal brace.
Intervention
ACTIVE COMPARATORA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- AIS patients who are prescribed braces to treat their spinal deformity.
You may not qualify if:
- Any one does not want to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicine and Dentistry
Edmonton, Alberta, T6G2R7, Canada
Related Publications (1)
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.
PMID: 28795156DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edmond Lou, PhD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 19, 2016
Study Start
January 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
December 19, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share