Functional Intimate Apparel for Adolescents With Early Scoliosis

Study Overview
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Brief Summary
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Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spinal 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; 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 a 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 a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.

Detailed Description
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This project aims to combine clinical experience with textiles and materials sciences to research and develop a 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 with 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 a functional intimate apparel to wear for 8 hours a day. Monitoring and observation will be provided during a 6-month wear trial. The effectiveness of the functional intimate apparel will be evaluated by pre- and post- treatment X-ray radiography and sonography.

Official Title
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Safety and Efficacy of Functional Intimate Apparel for Adolescents With Early Scoliosis

Conditions
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Scoliosis

Intervention / Treatment
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* Device: Functional Intimate Apparel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 10 to 13 years Diagnosis of AIS in early stage Primary Cobb angle 15-35 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are 2 groups of subjects. One group receives the treatment of functional intimate apparel which is called FIA group while one group receives observation only, which is called control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional intimate apparel<br>A functional intimate apparel will be provided to patient to wear it 8 hours daily. Monitoring and observation will be provided during the 6-9 months wearing period. | Device: Functional Intimate Apparel<br>* 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 with the application of 3-point pressure system, d) axial rotation or coupled motion by using uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.<br>|
| No Intervention: Control<br>Monitoring and observation will be provided during the 6-9 months wearing period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instant spinal correction | Measure lateral curvature of vertebra under x-ray. The instant effectiveness of the functional intimate apparel will be evaluated through radiography. | 2 hours after wearing the functional intimate apparel | 
| Six-month spinal control | Measure the lateral curvature by Scolioscan. The changes of spinal deformity over a period of 6 months will be evaluated through the sonography. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contour control | Measure the contour asymmetry by 3D body scanner. The changes of contour asymmetry over a period of 6 months will be evaluated by the 3D scanning images. | 6 months | 
| Back muscle activity | Measure the back muscle activity signals by the surface electromyography (sEMG) of back muscle. The changes of sEMG of back muscle over a period of 6 months will be evaluated. | 6 months | 
| Interface pressure of the functional intimate apparel | Measure the garment interface pressure by the Pliance pressure sensor. The bio-mechanics of the functional intimate apparel are assessed by the changes of pressure distribution. | 2 hours after wearing the functional intimate apparel and 6 months | 
| Health-related quality of life (EQ-5D-5L) | Measure the quality of life by the validated questionnaire, Euroqol (EQ-5D-5L) .The descriptive system comprises 5 dimensions in 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 0-no problems, 1-slight problems, 2-moderate problems, 3-severe problems and 4-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number by summed that describes the patient's health state.Total score are ranged from 0 to 20. The higher values represent a worse outcome. | 6 months | 
| Health-related quality of life (SRS-22) | Measure the quality of life by the validated questionnaire, SRS-22. The questionnaire consists of 22 questions and each question has 5 levels. The SRS-22r measures quality of life across 5 domains - Function (5 questions), Pain (5 questions) Self-Image (5 questions), Mental Health (5 questions), Satisfaction/Dissatisfaction (2 questions). The maximum score in each domain is 5 and minimum score is 1, with higher scores representing greater patient quality of life. The scores of each questions are summed to compute a total score. Total score are ranged from 22 to 110.The higher values represent a better outcome. | 6 months | 
| Patients' perception of self-image (TAPS) | Measure the subjective impression of trunk deformity by the calidated questionnaire, Trunk Appearance Perception Scale (TAPS). The TAPS includes 3 sets of figures that depict the trunk from 3 viewpoints: looking toward the back, looking toward the head with the patient bending over and looking toward the front. Drawings are scored from 1 (greatest deformity) to 5 (smallest deformity), and a mean score is obtained. The mean score are ranged from 1 to 5. The higher mean scores represent a better outcome. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional intimate apparel, Adolescent Idiopathic scoliosis