Safety and Efficacy of Body-mapping Tank Top Equipped With Biofeedback System for Adolescent With Early Scoliosis

Study Overview
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Brief Summary
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Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature on spine. Spine curvature increases in youths as puberty progresses. The recommended treatment for AIS is different depends on the spine deformity condition. For mild scoliosis (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid plastic material restrict nearly all movements of the wearers, which caused irritation. Flexible brace is an alternative option, however, the efficiency of such treatment is questionable in terms of controlling the spine curvature progression. Biofeedback has proven to be effective for a number of physical, psychological and psychophysical problems. The basic aim of biofeedback therapy is to support a patient in realizing his/her self-ability to control specific psychophysiological processes. In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a treatment option for AIS patients by monitoring the daily posture of the wearers.

Detailed Description
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This project aims to combine the clinical experience with textiles and biofeedback mechanism to research and develop a biofeedback embedded tank-top for AIS. 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 biofeedback tank-top to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (for measuring the angle of the spine), electromyography muscle signal assessment and clinical photographs assessment.

Official Title
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An Innovative Body-Mapping Tank Top Equipped With Biofeedback System for Adolescents With Early Scoliosis

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Device: Body-mapping Tank-top Embedded with Biofeedback System


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 between 10 -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

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tank top with biofeedback system<br>The design of biofeedback tank-top will incorporate sensors to record and monitor the posture of the wearer in real time basis. Alerts will be emitted to the wearer once poor posture is detected. The tank-top will be designed to fit the wearer's body and allow the sensor to be placed securely at the targeted position along the spine to minimize the noise from other factors than the wearers' posture and yet comfortable for long-term wearing. | Device: Body-mapping Tank-top Embedded with Biofeedback System<br>* In this study, the eligible subjects will be given tailor-made tank-top embedded with biofeedback system to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (measuring the angle of the spine) and electromyography muscle signal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of the spinal curve | No progression of the spinal curve (evaluated by pre-and post- treatment ultrasonic imaging device) | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of the spinal curve | The progression of the spinal curve within control (increase spinal angle < 5 degrees) | From baseline to 6 months | 
| Posture improvement | Improvement of posture by clinical photographs assessment and electromyography muscle signal | From baseline to 6 months |