Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis
Primary Purpose
Scoliosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flexible brace
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring Flexible brace
Eligibility Criteria
Inclusion Criteria:
- Teenagers diagnosed with adolescent idiopathic scoliosis
- Cobb's angle between 20 to 45 degrees
- Immature skeletons (Risser grade 0-2)
- Types of scoliosis are classified by the Lenke classification system
- Have received rigid brace treatment
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 treatment for AIS
- Contraindications for pulmonary and/ or exercise tests
- Psychiatric disorders
- Recent trauma
- Recent traumatic (emotional) event
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flexible brace
Arm Description
The design of the flexible brace incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) artificial hinge bone for the strategical application and fixation of corrective panel, 3) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.
Outcomes
Primary Outcome Measures
In-flexible brace Cobb angle measurements
The lateral curve of vertebra on spine x-ray AP view (unit: degree) will be measured by using EOS® low dose x-ray.
Secondary Outcome Measures
Force measurements
The pressure forces (unit: kpa) between the flexible brace and trunk will be measured by using Pliance® electronic analyser.
Visual analogue scale
A visual analogue scale (VAS) for pain due to the flexible brace, a VAS for motivation and a VAS for quality of life graded 0 to 100 mm will also be used. For pain, 0 represents the absence of pain as a motivation, and 0 represents the absence of discomfort in daily life.
Full Information
NCT ID
NCT04116723
First Posted
October 3, 2019
Last Updated
September 22, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04116723
Brief Title
Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis
Official Title
Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (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
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Scoliosis is the three-dimensional (3D) deformity of the spine and trunk. The majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. The progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems in their adult life Bracing is the most commonly used non-invasive treatment for patients with smaller spinal curves which are usually between 21 and 40 degrees at Risser stage 0, 1 or 2. However, scoliosis braces are traditionally constructed based on the experience of orthotists. Since 3D spinal deformities are complex, the design and evaluation of braces are challenging with no consensus on an optimal brace design. AI and ML methods therefore constitute a new approach to address the difficulties in designing braces.
Detailed Description
The designs of flexible brace include: an artificial hinge bone is used to stabilize the corrective components. Corrective straps are attached to the artificial hinge to exert corrective forces onto the scoliotic spine. Semi-rigid silicon pads with high conformability to the body are used to enhance the corrective forces.
This study is a multi-disciplinary collaborative project with experts in computer science, orthopaedics, materials science, garment technology, engineering and biomechanics. A biomechanical computational model will be developed to recommend modifications to the flexible brace design. The effectiveness of the flexible braces will be evaluated through low-dose X-ray radiography at pre-, post-expert and post-ML designed treatment. A polynomial scoring system will be created to assess the therapeutic similarity of the ML-designed flexible brace to the expert-designed flexible brace based on an estimate of the corrective forces applied through the braces. Reinforcement learning with scores based on estimated pressure force will guide AI training towards superior therapeutic designs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Flexible brace
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flexible brace
Arm Type
Experimental
Arm Description
The design of the flexible brace incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) artificial hinge bone for the strategical application and fixation of corrective panel, 3) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.
Intervention Type
Device
Intervention Name(s)
Flexible brace
Intervention Description
Participants will be invited to undergo a fitting session of a flexible brace. After the fitting session, participants will join a two-hours wear trial of the flexible brace. Participants are required to wear the brace for two-hours and undergo assessments before and after the wear trial. The measurement outcomes of the assessment include 1) X-ray scan, 2) 3D body scan, 3) garment pressure, and 4) questionnaire.
Primary Outcome Measure Information:
Title
In-flexible brace Cobb angle measurements
Description
The lateral curve of vertebra on spine x-ray AP view (unit: degree) will be measured by using EOS® low dose x-ray.
Time Frame
2 hours after wearing the brace
Secondary Outcome Measure Information:
Title
Force measurements
Description
The pressure forces (unit: kpa) between the flexible brace and trunk will be measured by using Pliance® electronic analyser.
Time Frame
2 hours after wearing the brace
Title
Visual analogue scale
Description
A visual analogue scale (VAS) for pain due to the flexible brace, a VAS for motivation and a VAS for quality of life graded 0 to 100 mm will also be used. For pain, 0 represents the absence of pain as a motivation, and 0 represents the absence of discomfort in daily life.
Time Frame
2 hours after wearing the brace
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Teenagers diagnosed with adolescent idiopathic scoliosis
Cobb's angle between 20 to 45 degrees
Immature skeletons (Risser grade 0-2)
Types of scoliosis are classified by the Lenke classification system
Have received rigid brace treatment
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 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Yip, PhD
Phone
852-27664848
Email
tcjyip@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Kit-Lun Yick, PhD
Phone
852-27666551
Email
kit-lun.yick@polyu.edu.hk
12. IPD Sharing Statement
Learn more about this trial
Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis
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