Trial of Posture Correction Girdle for Adolescents With Early Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posture Correction Girdle.
- Who it may be relevant to
- Registry conditions: Scoliosis. Basic parameters: 10 years — 13 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Overview
Adolescent idiopathic scoliosis (AIS) is a prevalent chronic condition that gradually leads to the three dimensional deformity of the spine. Spine curvature increases in youths as puberty progresses. Generally, only observation is suggested for adolescents with early scoliosis (Cobb's angle ≤ 20°). Rigid brace treatment is too draconian for them due to the high corrective force which nearly constrains all movements. Flexible brace treatment is an alternative option; however, its efficacy is still controversial. Posture correction girdle with a specialized design for teenagers with scoliosis is limited and most part of them can only provide some improvement for bad postures, such as hunchback. A scientific approach should be used to design and develop posture correction girdle as a treatment option for adolescents with early scoliosis.
Detailed description
The design of posture correction girdle will incorporate different mechanisms, such as
1. compression and pulling forces through a close fit of the intimate apparel 2. lumbar flexion by using a supporting belt 3. transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system 4. axial rotation or coupled motion by using a system with uneven straps, and 5. an active mechanism that aims to shift the trunk away from areas of pressure.
Interventions
- Device Posture Correction Girdle
Participants will be invited to undergo a fitting session of posture correction girdle. After the fitting, participants will join a 6-month wear trial of the posture correction girdle. Participants are required to wear the girdle for 8 hours a day and the compliance will be recorded by a logbook daily. Participants will be invited to undergo assessments before the wear trial, after the trial of 3 months, and after the trial of 6 months. The measure outcomes of the assessment include 1) ultrasoun
Primary outcome measures
- Effectiveness of posture correction girdle [Time frame: 6 months]
Secondary outcome measures (1)
- Posture improvement [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of AIS
- Cobb's angle 10˚-20˚
- Risser grade ≤ 2
- 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 anisotropic textile braces protocol
Exclusion criteria
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- History of previous surgical or orthotic treatment for AIS
- Contraindications for pulmonary and/ or exercise tests
- Psychiatric disorders
- Recent trauma
- Recent traumatic (emotional) event
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT03332251 · GRF2017