Skip to main content
OpenTrials
Completed

NCT Number: NCT02471508

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–13 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

The Hong Kong Polytechnic University

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body-mapping Tank-top Embedded with Biofeedback System

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Posture improvement

    Time frame: From baseline to 6 months

    Improvement of posture by clinical photographs assessment and electromyography muscle signal

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 15, 2015
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.