Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

Not Applicable

Recruiting

• Conditions: Scoliosis
• Interventions: Device: Posture Correction Girdle

• Registration Number: NCT03332251
• Lead Sponsor: The Hong Kong Polytechnic University

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. 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.

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-06
• Study Start: 2018-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Diagnosis of AIS
• Cobb's angle 10˚-20˚
• Risser grade ≤ 2
• No prior treatment
• Pre-menarche or post- menarche by no more than 1 year
• Ability to read and understand English or Chinese
• Physical and mental ability to adhere to anisotropic textile braces protocol

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posture Correction Girdle	Posture Correction Girdle	The design of posture correction girdle 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 Outcome Measures

Name	Time	Method
Effectiveness of posture correction girdle	6 months	The spinal curve progression is said to be under control if the increase in the Cobb's angle is \<5°

Secondary Outcome Measures

Name	Time	Method
Posture improvement	6 months	Improvement of posture by clinical photographs assessment

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇨🇳 Hong Kong, China