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Trial record 10 of 38 for:    "Spinal Disease" | "Benzocaine"

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT02589106
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Joanne Yip, The Hong Kong Polytechnic University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Scoliosis Device: Anisotropic Textile Braces Not Applicable

Detailed Description:

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

  1. axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk,
  2. 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining,
  3. pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands,
  4. derotation between the pelvis and shoulders with uneven straps, and
  5. an active mechanism with sensors added to the brace to maintain correct posture.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Anisotropic Textile Braces
The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials: a) axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk, b) 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining, c) pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands, d) derotation between the pelvis and shoulders with uneven straps, and e) an active mechanism with sensors added to the brace to maintain correct posture.
Device: Anisotropic Textile Braces
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 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 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02589106


Locations
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China
The Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University

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Responsible Party: Joanne Yip, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02589106     History of Changes
Other Study ID Numbers: GRF2016
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Keywords provided by Joanne Yip, The Hong Kong Polytechnic University:
Anisotropic Textile Braces
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases