Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-07 @ 1:48 AM
Study NCT ID:
NCT03332251
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2017-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Posture Correction Girdle for Adolescents With Early Scoliosis
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: