RecruitingNot ApplicableNCT02589106

Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis

Safety and Efficacy of Anisotropic Textile Braces for Adolescent Idiopathic Scoliosis


Sponsor

The Hong Kong Polytechnic University

Enrollment

15 participants

Start Date

Jan 1, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 10 YearsMax Age: 14 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

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Interventions

DEVICEAnisotropic Textile Braces

The period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study


Locations(2)

The Hong Kong Polytechnic University

Hong Kong, Guangdong, China

The Hong Kong Polytechnic University

Hong Kong, China

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NCT02589106


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