NCT03332251

Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 13 Years
• Healthy volunteers: Not accepted

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. Posture correction girdle 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 posture correction girdle as a treatment option for adolescents with early scoliosis.

Detailed description

The design of posture correction girdle will incorporate different mechanisms, such as 1. compression and pulling forces through a close fit of the intimate apparel 2. lumbar flexion by using a supporting belt 3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system 4. axial rotation or coupled motion by using a system with uneven straps, and 5. an active mechanism that aims to shift the trunk away from areas of pressure.

Conditions

• Scoliosis

Interventions

Type	Name	Description
DEVICE	Posture Correction Girdle	Participants will be invited to undergo a fitting session of posture correction girdle. After the fitting, participants will join a 6-month wear trial of the posture correction girdle. Participants are required to wear the girdle for 8 hours a day and the compliance will be recorded by a logbook daily. Participants will be invited to undergo assessments before the wear trial, after the trial of 3 months, and after the trial of 6 months. The measure outcomes of the assessment include 1) ultrasound scanning image, 2) 3D body scan, 3) electromyography signal, 4) garment pressure, and 5) questionnaire.

Timeline

• Start date: 2018-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2017-11-06
• Last updated: 2024-10-15

Locations

1 site across 1 country: China