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NCT Number: NCT03332251

Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–13 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The design of posture correction girdle will incorporate different mechanisms, such as

  • compression and pulling forces through a close fit of the intimate apparel
  • lumbar flexion by using a supporting belt
  • transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system
  • axial rotation or coupled motion by using a system with uneven straps, and
  • an active mechanism that aims to shift the trunk away from areas of pressure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posture Correction Girdle

Device

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.

Primary outcomes

  1. Effectiveness of posture correction girdle

    Time frame: 6 months

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

Secondary outcomes

  1. Posture improvement

    Time frame: 6 months

    Improvement of posture by clinical photographs assessment

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2017
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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