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NCT Number: NCT03716843

Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

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.

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Key information

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pressure monitoring system

Other

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 names: Pressure measurement undergarment

Primary outcomes

  1. Overall pressure distribution and dynamic pressure

    Time frame: 2 hours after wearing the brace

    • Dynamic Pressure Changes (kPa) Monitored Over 2 Hours of Brace Wear, as Measured by the Optical Fibre Sensors.
    • Overall Pressure Distribution (kPa) Monitored Over 2 Hours of Brace, as Measured by the Optical Fibre Sensors.

Secondary outcomes

  1. Scoliosis Research Society Quality of Life Questionnaire

    Time frame: 6 months after wearing the brace

    • Change in Scoliosis Research Society Score (SRS-22r) for Quality of Life Before and After Brace Usage. It includes five domains that evaluate function, pain, self-image, psychosocial status and satisfaction with the treatment and will be distributed to both experimental and control groups at 0 and 6 months. It has a minimum score of 22 and a maximum score of 110, with higher scores representing greater patient quality of life.
  2. Visual analogue scale

    Time frame: 6 months after wearing the brace

    • Change in Visual Analogue Scale (VAS) Scores for Pain Before and After Brace Usage.

    VAS is a straight horizontal line measuring 100 mm. The ends are defined as the extreme limits of pain, oriented from the left at 0 mm to the right at 100 mm. Typically, higher scores indicate a worse outcome, i.e., more pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Joanne Yip, PhD

CONTACT

[email protected]

852-27664848

Kit Yick, PhD

CONTACT

[email protected]

852-27666551

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • The University of Hong Kong
  • Washington University School of Medicine

Registry information

Official study title

Design of a Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2018
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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