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Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03332251
Enrollment
15
Registered
2017-11-06
Start date
2018-03-01
Completion date
2025-12-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Posture Correction Girdle

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.

Interventions

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of posture correction girdle6 monthsThe spinal curve progression is said to be under control if the increase in the Cobb's angle is \<5°

Secondary

MeasureTime frameDescription
Posture improvement6 monthsImprovement of posture by clinical photographs assessment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026