Safety and Efficacy of Body-mapping Tank Top Equipped With Biofeedback System for Adolescent With Early Scoliosis
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|ClinicalTrials.gov Identifier: NCT02471508|
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Device: Body-mapping Tank-top Embedded with Biofeedback System||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Innovative Body-Mapping Tank Top Equipped With Biofeedback System for Adolescents With Early Scoliosis|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Tank top with biofeedback system
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
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
- Progression of the spinal curve [ Time Frame: From baseline to 6 months ]No progression of the spinal curve (evaluated by pre-and post- treatment ultrasonic imaging device)
- Progression of the spinal curve [ Time Frame: From baseline to 6 months ]The progression of the spinal curve within control (increase spinal angle < 5 degrees)
- Posture improvement [ Time Frame: From baseline to 6 months ]Improvement of posture by clinical photographs assessment and electromyography muscle signal
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): NCT02471508
|The Hong Kong Polytechnic University|
|Hong Kong, China|