Dynamic Pressure Monitoring System for Orthotic Treatment of Scoliosis

NCT03716843 | Recruiting DMC

• 1 other identifier: GRF2019
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Dynamic Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Overall pressure distribution and dynamic pressure

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

  2 hours after wearing the brace

Secondary Outcomes (2)

• Scoliosis Research Society Quality of Life Questionnaire

  6 months after wearing the brace

• Visual analogue scale

  6 months after wearing the brace

Study Arms (1)

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

Interventions

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.

Also known as: Pressure measurement undergarment

Pressure monitoring system for AIS

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

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

Study Sites (1)

The Hong Kong Polytechnic University

Tsim Sha Tsui, Kolwoon, 00852, Hong Kong

RECRUITING

Study Officials

• Joanne Yip, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Yip, PhD

CONTACT

852-27664848; joanne.yip@polyu.edu.hk

Kit Yick, PhD

CONTACT

852-27666551; tcyick@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 23, 2018
• Study Start: January 2, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)