NCT02471508

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 10 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2015-06-15
• Last updated: 2017-03-03

Locations

1 site across 1 country: China