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RecruitingNCT03332251Updated Oct 15, 2024

Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

An interventional study of Posture Correction Girdle in Scoliosis, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in China. Open to female participants aged 10 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2018; still recruiting 8 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
10 Years to 13 Years
Sex
Female
01

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.

Read the 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.
02

Conditions studied

  • Scoliosis

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Keywords

  • Posture Correction Girdle
03

In context

Scoliosis

603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.

This study's planned enrollment of 15 is below the median of 44 across 350 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 676 studies on the registry; 254 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 13 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    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

    Device: Posture Correction Girdle

  • No intervention
    Control

    No treatment will be provided for control participants.

Interventions

  • DevicePosture 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.

06

What researchers measure

Primary outcomes

  1. Effectiveness of posture correction girdle

    The spinal curve progression is said to be under control if the increase in the Cobb's angle is \<5°

    Time frame: 6 months

Secondary outcomes

  1. Posture improvement

    Improvement of posture by clinical photographs assessment

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03332251
Responsible party
Joanne Yip (Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Nov 6, 2017
Start date
Mar 1, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Oct 15, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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