Overview

This trial is active, not recruiting.

Condition adolescent idiopathic scoliosis
Treatment body-mapping tank-top embedded with biofeedback system
Phase phase 1
Sponsor The Hong Kong Polytechnic University
Start date June 2015
End date July 2016
Trial size 12 participants
Trial identifier NCT02471508, ITS/283/13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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

Primary Outcomes

Measure
Progression of the spinal curve
time frame: From baseline to 6 months

Secondary Outcomes

Measure
Progression of the spinal curve
time frame: From baseline to 6 months
Posture improvement
time frame: From baseline to 6 months

Eligibility Criteria

Female participants from 10 years up to 13 years old.

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

Additional Information

Official title An Innovative Body-Mapping Tank Top Equipped With Biofeedback System for Adolescents With Early Scoliosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by The Hong Kong Polytechnic University.