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Functional Intimate Apparel for Adolescents With Early Scoliosis

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ClinicalTrials.gov Identifier: NCT02271256
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2014
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Joanne Yip, The Hong Kong Polytechnic University

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. Functional intimate apparel 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 functional intimate apparel as a treatment option for adolescents with early scoliosis.

This project aims to combine clinical experience with textiles and materials sciences to research and develop functional intimate apparel for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.

In this study, the eligible subjects will be given tailor-made functional intimate apparel to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months wearing period. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography.


Condition or disease Intervention/treatment Phase
Scoliosis Device: Functional Intimate Apparel Not Applicable

Detailed Description:

This project aims to combine clinical experience with textiles and materials sciences to research and develop functional intimate apparel for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery.

The design of functional intimate apparel 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.

In this study, the eligible subjects will be given tailor-made functional intimate apparel to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months wearing period. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional intimate apparel
A tailor-made functional intimate apparel will be provided to patient to wear it 8 hours daily. Monitoring and observation will be provided during the 12-18 months wearing period. Clinical, radiography, self-report and follow-up after completion of the study
Device: Functional Intimate Apparel
The design of functional intimate apparel 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.
Other Name: Posture correction girdle




Primary Outcome Measures :
  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 Outcome Measures :
  1. Posture improvement [ Time Frame: 18 months ]
    Improvement of posture by clinical photographs assessment



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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 10 to 13 years
  • Diagnosis of AIS in early stage
  • Primary Cobb angle equals to or less than 20 degrees
  • Pre-menarche or post- menarche by no more than 1 year
  • Ability to read and understand English or Chinese
  • At high risk for curve progression
  • Skeletally immature (Risser grade 0,1 or 2)
  • Physical and mental ability to adhere to functional intimate apparel 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271256


Locations
China
The Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Joanne Yip, PhD The Hong Kong Polytechnic University

Responsible Party: Joanne Yip, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02271256     History of Changes
Other Study ID Numbers: GRF2015
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanne Yip, The Hong Kong Polytechnic University:
Functional intimate apparel
Adolescent Idiopathic scoliosis

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases