Overview

This trial is active, not recruiting.

Condition scoliosis
Treatment functional intimate apparel
Phase phase 0
Sponsor The Hong Kong Polytechnic University
Start date January 2016
End date December 2019
Trial size 20 participants
Trial identifier NCT02271256, GRF2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
A tailor-made functional intimate apparel will be provided to patient to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months wearing period. Clinical, radiography, self-report and follow-up after completion of the study
functional intimate apparel Posture correction girdle
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.

Primary Outcomes

Measure
Progression of the spinal curve
time frame: 18 months

Secondary Outcomes

Measure
Posture improvement
time frame: 18 months

Eligibility Criteria

Female participants from 10 years up to 13 years old.

Inclusion Criteria: - Aged 10 to 13 years - Diagnosis of AIS in early stage - Primary Cobb angle equals to or less than 20 degrees - Pre-menarche or post- menarche by no more than 1 year - Ability to read and understand English or Chinese - At high risk for curve progression - Skeletally immature (Risser grade 0,1 or 2) - Physical and mental ability to adhere to functional intimate apparel protocol Exclusion Criteria: - Contraindications for x-ray exposure - Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature - History of previous surgical or orthotic treatment for AIS - Contraindications for pulmonary and/ or exercise tests - Psychiatric disorders - Recent trauma - Recent traumatic (emotional) event

Additional Information

Official title Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis
Principal investigator Joanne Yip, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The Hong Kong Polytechnic University.