AzTrials
AzTrials

ScoliosisNCT04116723

Trial of Flexible Bracing Treatment of Adolescents Idiopathic Scoliosis

A study testing Flexible brace in people with Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Scoliosis is the three-dimensional (3D) deformity of the spine and trunk. The majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. The progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems… Read more about this study

Who is it for?
Ages 10 to 15 years, women only
Conditions the study is for
Scoliosis
What is being tested?
Flexible brace
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Jan 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Teenagers diagnosed with adolescent idiopathic scoliosis
  • Cobb's angle between 20 to 45 degrees
  • Immature skeletons (Risser grade 0-2)
  • Types of scoliosis are classified by the Lenke classification system
  • Have received rigid brace treatment

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The Hong Kong Polytechnic University

    Hong Kong

    Joanne Yip, PhD, 852-27664848, tcjyip@polyu.edu.hk

    Kit-Lun Yick, PhD, 852-27666551, kit-lun.yick@polyu.edu.hk

    Recruiting

Other trials in China

About this study

Scoliosis is the three-dimensional (3D) deformity of the spine and trunk. The majority or 80% of the scoliosis cases are idiopathic which means that the cause is unknown. The progression of scoliosis is much more frequently seen in females and severely scoliotic patients face a higher risk of different health problems in their adult life Bracing is the most commonly used non-invasive treatment for patients with smaller spinal curves which are usually between 21 and 40 degrees at Risser stage 0, 1 or 2. However, scoliosis braces are traditionally constructed based on the experience of orthotists. Since 3D spinal deformities are complex, the design and evaluation of braces are challenging with no consensus on an optimal brace design. AI and ML methods therefore constitute a new approach to address the difficulties in designing braces.

Read the detailed description

The designs of flexible brace include: an artificial hinge bone is used to stabilize the corrective components. Corrective straps are attached to the artificial hinge to exert corrective forces onto the scoliotic spine. Semi-rigid silicon pads with high conformability to the body are used to enhance the corrective forces.

This study is a multi-disciplinary collaborative project with experts in computer science, orthopaedics, materials science, garment technology, engineering and biomechanics. A biomechanical computational model will be developed to recommend modifications to the flexible brace design. The effectiveness of the flexible braces will be evaluated through low-dose X-ray radiography at pre-, post-expert and post-ML designed treatment. A polynomial scoring system will be created to assess the therapeutic similarity of the ML-designed flexible brace to the expert-designed flexible brace based on an estimate of the corrective forces applied through the braces. Reinforcement learning with scores based on estimated pressure force will guide AI training towards superior therapeutic designs.

Conditions
Scoliosis
Being tested
Flexible brace
Keywords
Flexible brace
Medical subject headings
Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flexible braceDevice

    Participants will be invited to undergo a fitting session of a flexible brace. After the fitting session, participants will join a two-hours wear trial of the flexible brace. Participants are required to wear the brace for two-hours and undergo assessments before and after the wear trial. The measurement outcomes of the assessment include 1) X-ray scan, 2) 3D body scan, 3) garment pressure, and 4) questionnaire.

Study groups in NCT04116723
Study groupRoleWhat they receive
Flexible braceExperimentalThe design of the flexible brace incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) artificial hinge bone for the strategical application and fixation of corrective panel, 3) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.
Receives: Device: Flexible brace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-flexible brace Cobb angle measurements

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

    Measured: 2 hours after wearing the brace

Secondary outcomes (2)

  1. Idea pressure level measurements

    1. The amount of pressure forces (kPa) exerted by the brace at minimum Cobb angles will be aggregated to ideal pressure level measurements (kPa/Cobb angles). Pressure forces will be measured by the Novel Pliance-xf-16 analyzer, while the Cobb angles will be measured by spine MRI.

    Measured: 2 hours after wearing the brace

  2. Visual analogue scale (VAS) Scores

    1. Change in Visual Analogue Scale (VAS) Scores for Pain Before and After Brace Usage.
    2. Change in Visual Analogue Scale (VAS) Scores for Quality of Life 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.

    Measured: 2 hours after wearing the brace

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2019
  2. Study start1 Jan 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04116723
Sponsor's protocol ID
GRF2020
Status last verified
Oct 2024
First submitted
3 Oct 2019
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Flexible brace in people with Scoliosis, run by The Hong Kong Polytechnic University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-flexible brace Cobb angle measurements (time frame: 2 hours after wearing the brace). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in