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

NCT02471508 | Completed Phase 1 DMC

• 1 other identifier: ITS/283/13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progression of the spinal curve

  From baseline to 6 months

• Posture improvement

  From baseline to 6 months

Study Arms (1)

Tank top with biofeedback system

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.

Device: Body-mapping Tank-top Embedded with Biofeedback System

Interventions

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

Tank top with biofeedback system

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-02

Locations

CN (1)