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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05790031
Recruitment Status : Enrolling by invitation
First Posted : March 29, 2023
Last Update Posted : April 3, 2023
Sponsor:
Information provided by (Responsible Party):
Joanne Yip, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Device: Intelligent Nighttime Brace Not Applicable

Detailed Description:

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

  1. compression and pulling forces through a customizable rigid brace
  2. lumbar flexion by using a supporting air-belt.
  3. three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction
  4. adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Intelligent Nighttime Brace With Smart Padding to Treat of Adolescent Idiopathic Scoliosis
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intelligent Nighttime Brace
The design of intelligent nighttime brace will incorporate different mechanism, such as a) compression and pulling forces through a customisable rigid brace, b) lumbar flexion by using a supporting air-belt, c) three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction, d) adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users
 Device: Intelligent Nighttime Brace
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


Outcome Measures
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Primary Outcome Measures :
  1. The Cobb angle measurements of intelligent nighttime brace [ Time Frame: 2 hours after wearing the brace and 6 months ]
    Measure lateral curvature of vertebra on spine x-ray AP view (unit: degree) will be measured by using EOS® low does x-ray.


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of previous surgical or orthotic treatment for AIS
  2. Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
  3. Contraindications for pulmonary and/ or exercise tests
  4. Psychiatric disorders
  5. Recent trauma
Contacts and Locations
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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): NCT05790031


Locations
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China
The Hong Kong Polytechnic University
Hong Kong, China
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Joanne Yip, phd The Hong Kong Polytechnic University
More Information
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Responsible Party: Joanne Yip, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT05790031    
Other Study ID Numbers: ITS/007/22
First Posted: March 29, 2023    Key Record Dates
Last Update Posted: April 3, 2023
Last Verified: March 2023

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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:
Scoliosis, Bracing Treatment
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases