Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05790031

Trials of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. Generally, bracing treatment is a common option for scoliosis patients. Non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. Therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. However, its efficacy is still controversial. Intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. A scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adolescent Idiopathic Scoliosis Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

10 year–13 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, China

Location status: Recruiting

Location contact

Joanne Yip, phd

CONTACT

About this study

The design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as

  • compression and pulling forces through a customizable rigid brace
  • lumbar flexion by using a supporting air-belt.
  • three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction
  • adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • between the ages of 10-13,
  • scoliosis with a Cobb angle larger between 10 -25 degrees;
  • No prior treatment
  • Pre-menarche or post- menarche by no more than 1 year
  • Ability to read and understand English or Chinese
  • Physical and mental ability to adhere to intelligent nighttime braces protocol

Exclusion criteria

  • History of previous surgical or orthotic treatment for AIS
  • Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
  • Contraindications for pulmonary and/ or exercise tests
  • Psychiatric disorders
  • Recent trauma

Treatment and study plan

Intelligent Nighttime Brace

Device

Participants will be invited to undergo a fitting session of intelligent nighttime brace. After the fitting, participants will join a 6-month wear trial of the intelligent nighttime brace. Participants are required to wear the intelligent nighttime brace for 8 hours a day during sleeping and compliance will be recorded by an intelligent monitoring system. Participants will be invited to undergo assessments before the wear trial, after the trials of 3 months and after the trial of 6 months. The measure outcomes of the assessment include 1)ultrasound scanning image, 2)3D body scanning, 3)garment pressure, 4) questionnaires

Primary outcomes

  1. Investigate the in-brace Cobb angle

    Time frame: 2 hours and 6 months after wearing the brace

    • Number of Participants Maintaining Cobb Angle Stability (<5° Increase) After Wearing the Brace for 2 Hours, as Measured by Spine X-ray (AP View).

Secondary outcomes

  1. Contour control

    Time frame: 6 months

    Use a 3D body scanner to measure the contour asymmetry. By using 3D scanning images, the contour asymmetry changes over a six-month period will be assessed.

  2. Force measurements and monitoring

    Time frame: 6 months

    Measure the brace interface pressure by the Novel Pliance-xf-16 analyser. The bio-mechanics of the intelligent nighttime brace are assessed by the changes of the pressure distribution. A real-time intelligent system is use to monitor the pressure distribution.

  3. Health-related quality of life (SRS-22)

    Time frame: 6 months

    Measure the quality of life by validated questionnaire, Euroqol (EQ-5D-5L). The five dimensions of the descriptive system are mobility, self-care, regular activities, pain/comfort, and anxiety/depression. The patients with higher values represent a worse outcome.

Study contacts

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

Joanne Yip, phd

CONTACT

[email protected]

852-27665111 ext. 4848

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 29, 2023
Registry last updated
Oct 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.