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Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Primary Purpose

Scoliosis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anisotropic Textile Braces
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Anisotropic Textile Braces

Eligibility Criteria

10 Years - 14 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anisotropic Textile Braces

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Posture improvement
Improvement of posture by clinical photographs assessment

Full Information

First Posted
October 27, 2015
Last Updated
September 22, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02589106
Brief Title
Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Official Title
Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Anisotropic Textile Braces

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anisotropic Textile Braces
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anisotropic Textile Braces
Intervention Description
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 Measure Information:
Title
Progression of the spinal curve
Description
The spinal curve is said to be under control if the increase in the Cobb's angle is <5°
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Posture improvement
Description
Improvement of posture by clinical photographs assessment
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
China

12. IPD Sharing Statement

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Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

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