Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471508
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Joanne Yip, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Device: Body-mapping Tank-top Embedded with Biofeedback System Phase 1

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Innovative Body-Mapping Tank Top Equipped With Biofeedback System for Adolescents With Early Scoliosis
Actual Study Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tank top with biofeedback system
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
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471508


Locations
Layout table for location information
China
The Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Layout table for additonal information
Responsible Party: Joanne Yip, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02471508    
Other Study ID Numbers: ITS/283/13
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases