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

NCT02471508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

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

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-07-31
Completion
2016-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471508 on ClinicalTrials.gov