A Randomized Clinical Trial of Brace Treatment

NCT03022656 | Terminated

• 1 other identifier: Pro00058476
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Brace treatment is the most effective non-surgical method for the treatment of Adolescent idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with pressure pads installed inside the liner to provide mechanical support to the curvature of the spine. It is a big commitment for adolescents to wear a brace because it is physically restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to make the brace treatment as effective as possible to get patient buy-in to compromise their lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to attain their compliance. This randomized clinical study will investigate if the effectiveness of brace treatment can be maximized by combining ultrasound imaging assistance during brace design with the smart brace to automatically maintain corrective brace pressures at the optimum level during the whole treatment period.

Conditions

Scoliosis; Idiopathic, Infantile

Keywords

Orthotic treatment, Ultrasound Imaging

Outcome Measures

Primary Outcomes (2)

• Effectiveness of active brace treatment

  The proportions of successful treatment between two arms b to determine the overall effectiveness

  2 years after completing the brace treatment

• Immediate Active effect

  Review the out of brace Cobb angle 1 year after using the spinal brace

  1 year after enrollment

Study Arms (2)

Monitor Only

ACTIVE COMPARATOR

A brace monitor will be embedded inside the brace to monitor compliance.

Device: Active Brace system

Active Brace System

ACTIVE COMPARATOR

An active brace device will be embedded inside the brace to dynamically control interface pressure and monitor compliance.

Device: Active Brace system

Interventions

Active Brace system DEVICE

Active Brace System; Monitor Only

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 10 - 16 years
• diagnosed of AIS
• require full-time brace wear
• have Cobb angle between 20° - 40°
• have Risser sign ≤3
• premenarchal or less than 1 year postmenarchal.

You may not qualify if:

• patients who require surgery
• presenting with associated musculoskeletal, neurological or other conditions possibly responsible for the curvature
• physical or mental disability that prevent patients from complying with the bracing protocol

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 16, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 19, 2024

Record last verified: 2024-12