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Clinical Trials in China / NCT03332251
Recruiting Not applicable

Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

NCT03332251 · tracked via the Priya Life Science China tracker
Sponsor
The Hong Kong Polytechnic University
Phase
Not applicable
Started
2018-03-01
Last updated
2024-10-15

Condition(s) studied

Scoliosis

Investigational drug(s) / intervention(s)

Posture Correction Girdle

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
10 Years
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Hong Kong Polytechnic University Hong Kong China Recruiting

More The Hong Kong Polytechnic University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03332251 on ClinicalTrials.gov ↗ ← All trials in China