Clinical Trial: Functional Intimate Apparel for Adolescents With Early Scoliosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis

Brief Summary:

Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Functional intimate apparel with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop functional intimate apparel as a treatment option for adolescents with early scoliosis.

This project aims to combine clinical experience with textiles and materials sciences to research and develop functional intimate apparel for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.

In this study, the eligible subjects will be given tailor-made functional intimate apparel to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months wearing period. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography.


Detailed Summary:

This project aims to combine clinical experience with textiles and materials sciences to research and develop functional intimate apparel for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.

The design of functional intimate apparel will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system, d) axial rotation or coupled motion by using a system with uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.

In this study, the eligible subjects will be given tailor-made functional intimate apparel to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months wearing period. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography.


Sponsor: The Hong Kong Polytechnic University

Current Primary Outcome: Progression of the spinal curve [ Time Frame: 18 months ]

The spinal curve is said to be under control if the increase in the Cobb's angle is <5°


Original Primary Outcome: Same as current

Current Secondary Outcome: Posture improvement [ Time Frame: 18 months ]

Improvement of posture by clinical photographs assessment


Original Secondary Outcome: Same as current

Information By: The Hong Kong Polytechnic University

Dates:
Date Received: October 20, 2014
Date Started: January 2016
Date Completion: December 2020
Last Updated: April 13, 2016
Last Verified: April 2016