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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Body-mapping Tank-top Embedded with Biofeedback System
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

10 Years - 13 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tank top with biofeedback system

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression of the spinal curve
No progression of the spinal curve (evaluated by pre-and post- treatment ultrasonic imaging device)

Secondary Outcome Measures

Progression of the spinal curve
The progression of the spinal curve within control (increase spinal angle < 5 degrees)
Posture improvement
Improvement of posture by clinical photographs assessment and electromyography muscle signal

Full Information

First Posted
June 11, 2015
Last Updated
February 28, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02471508
Brief Title
Safety and Efficacy of Body-mapping Tank Top Equipped With Biofeedback System for Adolescent With Early Scoliosis
Official Title
An Innovative Body-Mapping Tank Top Equipped With Biofeedback System for Adolescents With Early Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tank top with biofeedback system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Body-mapping Tank-top Embedded with Biofeedback System
Intervention Description
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 Measure Information:
Title
Progression of the spinal curve
Description
No progression of the spinal curve (evaluated by pre-and post- treatment ultrasonic imaging device)
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Progression of the spinal curve
Description
The progression of the spinal curve within control (increase spinal angle < 5 degrees)
Time Frame
From baseline to 6 months
Title
Posture improvement
Description
Improvement of posture by clinical photographs assessment and electromyography muscle signal
Time Frame
From baseline to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
China

12. IPD Sharing Statement

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

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