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Clinical Trials/NCT03332251
NCT03332251
Recruiting
Not Applicable

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

The Hong Kong Polytechnic University1 site in 1 country15 target enrollmentMarch 1, 2018
ConditionsScoliosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis
Sponsor
The Hong Kong Polytechnic University
Enrollment
15
Locations
1
Primary Endpoint
Effectiveness of posture correction girdle
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joanne Yip

Professor

The Hong Kong Polytechnic University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Posture improvement(6 months)

Study Sites (1)

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