NCT02271256

Functional Intimate Apparel for Adolescents With Early Scoliosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 13 Years
• Healthy volunteers: Accepted

Summary

Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spinal 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; 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 a 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 a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.

Detailed description

This project aims to combine clinical experience with textiles and materials sciences to research and develop a 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 with 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 a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.

Conditions

• Scoliosis

Interventions

Type	Name	Description
DEVICE	Functional Intimate Apparel	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 with the application of 3-point pressure system, d) axial rotation or coupled motion by using uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.

Timeline

• Start date: 2017-07-15
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2014-10-22
• Last updated: 2022-08-16

Locations

1 site across 1 country: China