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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471508
• Other study ID #: ITS/283/13
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2015
• Last updated: February 28, 2017
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression of the spinal curve	The progression of the spinal curve within control (increase spinal angle < 5 degrees)	From baseline to 6 months
Secondary	Posture improvement	Improvement of posture by clinical photographs assessment and electromyography muscle signal	From baseline to 6 months