Clinical trial NCT02589106: Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Official title: Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis
Keywords: Anisotropic Textile Braces
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 15
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One of the most common types of 3-dimensional spinal deformities with unknown etiology in youths is adolescent idiopathic scoliosis (AIS). The spinal curvature increases as puberty progresses. Generally, rigid orthotic bracewear is prescribed as non-invasive treatment for moderate AIS if treatment begins early and the orthosis is worn with compliance. Obviously, teenage patients are reluctant to accept a rigid orthosis due to aesthetics and the physical constraint. Therefore, semi-rigid and flexible orthoses have been developed, but their efficacy is still controversial and there are other issues, such as high pain scores. There is clearly room for improvement. Therefore, a garment-type of bracewear will be designed and developed to correct spinal deformity, reduce the possibility of spinal curve progression, and satisfy the needs of the patients as well as take their psychological concerns into consideration.

Detailed description: The design of the anisotropic textile braces will provide different mechanisms with rigid, semi-rigid and flexible materials:

1. axial elongation through a close fit of the brace supported with textile composites on the lateral sides of the trunk,
2. 3-point pressure with push and counter-pushes through semi-rigid pads inserted inside the pocket lining,
3. pulling or compression to correct kyphosis or lordosis in the sagittal plane with elastic bands,
4. derotation between the pelvis and shoulders with uneven straps, and
5. an active mechanism with sensors added to the brace to maintain correct posture.

Eligibility criteria: Inclusion Criteria:

* Aged 10 to 14 years
* Diagnosis of AIS
* a Cobb's angle between 20 to 30 degrees
* a Risser grade of the iliac crest of ≤ 2
* 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:

* Contraindications for x-ray exposure
* 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

Primary outcomes:
measure: Progression of the spinal curve
timeFrame: 18 months
Secondary outcomes:
measure: Posture improvement
timeFrame: 18 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
state: Guangdong
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
References: