Trial of Posture Correction Girdle for Adolescents With Early Scoliosis

T

The Hong Kong Polytechnic University

Status

Invitation-only

Conditions

Scoliosis

Treatments

Device: Posture Correction Girdle

Study type

Interventional

Funder types

Other

Identifiers

NCT03332251
GRF2017

Details and patient eligibility

About

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.

Full description

The design of posture correction girdle will incorporate different mechanisms, such as compression and pulling forces through a close fit of the intimate apparel lumbar flexion by using a supporting belt transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system axial rotation or coupled motion by using a system with uneven straps, and an active mechanism that aims to shift the trunk away from areas of pressure.

Enrollment

15 estimated patients

Sex

Female

Ages

10 to 13 years old

Volunteers

No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Posture Correction Girdle
Experimental group
Description:
The design of posture correction girdle will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system, d) axial rotation or coupled motion by using a system with uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure
Treatment:
Device: Posture Correction Girdle
Control
No Intervention group
Description:
No treatment will be provided for control participants.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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