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Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

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ClinicalTrials.gov Identifier: NCT03716843
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
The University of Hong Kong
Washington University School of Medicine
Information provided by (Responsible Party):
Joanne Yip, The Hong Kong Polytechnic University

Brief Summary:
Adolescent idiopathic scoliosis (AIS) involves three-dimensional spinal deformity in children aged between 10 and 16. Traditional braces modify the natural dynamics and thus the mechanical behaviour of the scoliotic spine through external constraints. Patients usually develop pressure ulcers and skin irritation when prescribed brace treatment for 18-23 hours per day. The excessive pressure, unknown pressure distribution and pressure shifting between the human body and the brace causes the effects of brace treatment to be unpredictable. Dynamic pressure monitoring system will be developed based on the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the thoraco-lumbo-sacral orthosis (TLSO) rigid brace will be measured. The efficacy of the brace design will be evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.

Condition or disease Intervention/treatment
Adolescent Idiopathic Scoliosis Other: Pressure monitoring system

Detailed Description:

Global rates of adolescent idiopathic scoliosis (AIS) range from 0.9% to 12%, and within this population, approximately 10% of adolescents aged 10-16 will eventually need treatment. The most common conservative treatment is bracing, in which AIS patients are prescribed a brace for 18 to 23 hours daily until skeletally mature. The objective of bracing is to stop curve progression and restore normal alignment of the spine by active pressure from the brace. There is strong clinical evidence of a positive correlation between the tightness of daily brace application and the ability of the brace to decrease the risk of curve progression to a surgical threshold. However, patients suffer physical and functional discomfort resulting from pressure points, including pressure ulcers, skin irritation and even asthma attacks, which reduces compliance with brace treatment. Clearly, the knowledge of human body responses to pressure applied by brace treatment remains lacking.

This multi-disciplinary collaborative study involves experts in electrical and electronic engineering, orthopaedics, materials science and textiles, and biomechanics. A revolutionary pressure measurement system that integrates fibre optic sensors with textile yarns will be developed in the form of an undergarment. The sensor arrangement in the undergarment will be designed according to the body landmarks of scoliotic patients and critical areas where active pressure is applied by the brace. The overall pressure distribution and dynamic pressure between the body and the scoliosis brace will be measured. The efficacy of the brace design will be evaluated, and the maximum compressive stresses that patients can endure on different body parts without pressure injury can be computed.

Academia, clinicians and AIS patients are predicted to benefit from using the pressure system, which determines the optimum pressure to be exerted on patients while minimizing pressure injuries. The output of the project can be extended to the standardization of pressure levels applied by different orthotic devices and will add a new dimension to fibre optic applications in biomechanics.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
Pressure monitoring system for AIS

Adolescent idiopathic scoliosis (AIS) patients

(1) all target subjects are aged 10 to 15 years old with immature skeletons (Risser grade 0-2); (2) they are diagnosed with AIS with a Cobb angle between 25-45° and high risk for curve progression; (3) the types of scoliosis are classified by the Lenke classification system; and (4) the subjects have received rigid brace treatment.

Other: Pressure monitoring system

The pressure measurement undergarment will be given to all consenting AIS patients who have received their own thoraco-lumbo-sacral orthosis (TLSO) rigid brace. Each patient will wear the undergarment first and the TLSO brace on top. FBG sensors embedded in the undergarment will measure each pressure signal at approximately 2 minutes. The average force reading will be calculated.

Then, the experiment will be repeated once, but the anisotropic textile brace will replace the TLSO brace. The pressure measurement system will be used to obtain an accurate and adequate comparison of the forces applied to the patients. The effectiveness of the anisotropic textile brace will be evaluated through X-ray radiography, and its correction effect with be compared with that of the TLSO brace.

Other Name: Pressure measurement undergarment




Primary Outcome Measures :
  1. Investigate on brace Cobb's angle [ Time Frame: 2 hours after wearing the brace ]
    Measure lateral curve of vertebra on spine x-ray AP view. The effectiveness of the modified or anisotropic textile brace will be evaluated through X-ray radiography, and its correction effect will be compared with that of the TLSO brace.


Secondary Outcome Measures :
  1. Overall pressure distribution [ Time Frame: 2 minutes after wearing the brace ]
    The pressure measurement system will be used to obtain an accurate and adequate comparison of the forces (kPa) applied by TLSO brace and modified brace.

  2. Visual analogue scale [ Time Frame: 6 month ]
    A visual analogue scale (VAS) for pain due to the brace, a VAS for motivation and a VAS for quality of life graded 0 to 100 mm will also be used. For pain, 0 represents the absence of pain as a motivation, and 0 represents the absence of discomfort in daily life. Statistical analysis will be performed to determine the relationship between the level of brace correction force and effect. After this relationship is established, patients will no longer suffer unnecessary strain and pain caused by the brace. Optimum correction force will be achieved with higher patient comfort, reducing the possibility of developing pressure ulcers and improving user compliance.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be divided into two phases. In Phase 1, an exploratory pilot study will be performed with up to two different braces tried on the same patient in one spinal centre in Hong Kong.
Criteria

Inclusion Criteria:

  • Teenagers diagnosed with adolescent idiopathic scoliosis
  • Cobb's angle between 25 to 45 degrees
  • Immature skeletons (Risser grade 0-2)
  • Types of scoliosis are classified by the Lenke classification system
  • Have received rigid brace treatment

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 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): NCT03716843


Contacts
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Contact: Joanne Yip, PhD 852-27664848 joanne.yip@polyu.edu.hk
Contact: Kit Yick, PhD 852-27666551 tcyick@polyu.edu.hk

Locations
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Hong Kong
The Hong Kong Polytechnic University
Tsim Sha Tsui, Kolwoon, Hong Kong, 00852
Sponsors and Collaborators
The Hong Kong Polytechnic University
The University of Hong Kong
Washington University School of Medicine
Investigators
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Principal Investigator: Joanne Yip, PhD The Hong Kong Polytechnic University

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Responsible Party: Joanne Yip, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03716843    
Other Study ID Numbers: GRF2019
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joanne Yip, The Hong Kong Polytechnic University:
Dynamic Pressure Monitoring
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases