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NCT Number: NCT02589106

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University, Hong Kong, Guangdong, China

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About this study

The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials:

  • axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk,
  • 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining,
  • pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands,
  • derotation between the pelvis and shoulders with uneven straps, and
  • an active mechanism with sensors added to the brace to maintain correct posture.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 10 to 14 years
  • Diagnosis of AIS
  • a Cobb's angle between 20 to 30 degrees
  • a Risser grade of the iliac crest of ≤ 2
  • 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

  • Contraindications for x-ray exposure
  • 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

Anisotropic Textile Braces

Device

The period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study

Primary outcomes

  1. Progression of the spinal curve

    Time frame: 18 months

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

Secondary outcomes

  1. Posture improvement

    Time frame: 18 months

    Improvement of posture by clinical photographs assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Joanne Yip, PhD

CONTACT

[email protected]

852-27664848

Kit-Lun Yick, PhD

CONTACT

[email protected]

852-27666551

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2015
Registry last updated
Mar 13, 2025

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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