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NCT Number: NCT03617120

Ergonomic Brace Wear for Adolescent Idiopathic Scoliosis

This study assesses the effectiveness of a new scoliosis brace design for adolescent idiopathic scoliosis (AIS) patients, named Ergonomic Brace, by comparing the outcome with hard brace in terms of three aspects:

1. To assess the efficacy in spinal correction 2. To evaluate the improvement made to the body appearance of AIS subjects 3. To evaluate the impacts on the quality of life (QoL) of AIS subjects

All participants will be fitted with an Ergonomic Brace and required to wear it during the days of experiment only. The ongoing treatment with hard brace will not be substituted with the Ergonomic Brace, unless its immediate treatment effect is equivalent to hard brace and with approval from the doctor.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Tsim Sha Tsui, Kolwoon, 00852, Hong Kong

About this study

  • To assess the efficacy in spinal correction

The efficacy of the Ergonomic Brace refers to the magnitude of spinal correction that could be obtained for patients with AIS. The assessments in this study focus on two aspects, which are i) the in-brace correction and ii) the interface pressure. In-brace correction is used to judge the quality of bracing and also a prognostic indicator for the long-term treatment outcome. Clinical parameters such as Cobb angle, vertebral rotation and trunk listing will be measured with radiographs by a single observer. Interface pressure in this study refers to the pressure between the brace and the trunk of subject. The purpose is to assess the time response of trunk to the intervention of the Ergonomic Brace, and correlation will also be made with the extent of spinal correction.

  • To evaluate the improvement made to the body appearance of AIS subjects

The trunk aesthetic profile of AIS subjects are being affected by spinal deformities. Surface topography of the subjects will be captured by 3D body scanner, and followed by the evaluation of body aesthetics through the trunk asymmetry scales called POTSI and ATSI index. The purpose is to compare the surface topography change before and after wearing the Ergonomic Brace.

  • To evaluate the impacts on the QoL of AIS subjects

Bracing can negatively affect the QoL of patients with AIS. The Chinese version of Brace Questionnaire (BrQ) will be adopted in this study to compare the impact of hard brace and Ergonomic Brace on the QoL of AIS subjects. Difficulties experienced by AIS subjects during bracing will be highlighted and used for future improvements in scoliosis brace design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10 or older when brace is prescribed
  • Risser 0 to 2
  • Primary curve angles 25° to 40°
  • Female, who were either pre-menarche or less than 1 year of post-menarche
  • Undergoing hard brace treatment

Exclusion criteria

  • Low risk of curve progression
  • Non-idiopathic scoliosis (e.g. congenital, neuromuscular deformities)

Treatment and study plan

Ergonomic Brace vs hard brace

Device

Visit 1:

  • Usual check-up: standing in-brace radiograph of hard brace and doctor consultation
  • Pressure measurement of participant wearing their hard brace

Visit 2:

  • Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS)
  • 3D body scanning (before wearing the Ergonomic Brace)
  • Fitting of the Ergonomic Brace
  • Pressure measurement of participant wearing the Ergonomic Brace (instant)
  • Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours)
  • 3D body scanning (after wearing the Ergonomic Brace for 2 hours)
  • Brace Questionnaire (BrQ) for the Ergonomic Brace

Visit 3:

  • Standing in-brace radiograph of the Ergonomic Brace
  • Doctor consultation

Primary outcomes

  1. Immediate in-brace correction of spinal curve

    Time frame: 2 hours

    Cobb angle: more than/equal to 40% correction (lumbar/thoracolumbar curve); slightly less than/close to 40% correction (thoracic curve)

Secondary outcomes

  1. Immediate in-brace correction of vertebral rotation assessed by the Global Torsion Index

    Time frame: 2 hours

    Global torsion index: to quantify detorsion by averaging the 17 segmental rotations of thoracic and lumbar vertebrae

    • Higher index score = the average segmental rotations of the 17 vertebrae is higher;
    • Lower index score = the average segmental rotations of the 17 vertebrae is lower

    The global torsion index which result from wearing the Ergonomic Brace will be compared with which of hard brace. A higher/similar detorsion percentage as hard brace is considered satisfactory.

  2. Immediate in-brace correction of trunk listing assessed by the plumb line method

    Time frame: 2 hours

    Plumb line method: to assess the coronal and sagittal balance by drawing a vertical line from the mid-point of the C7 vertebra down to the sacrum

    • Positive balance: the plumb line passes more than 2 cm in front of the posterosuperior corner of the S1 vertebral body
    • Neutral balance: the plumb line passes within 2 cm of the posterosuperior corner of the S1 vertebral body
    • Negative balance: the plumb line passes more than 2 cm behind the posterosuperior corner of the S1 vertebral body

    Measurement of trunk listing is significant in the treatment of scoliosis curve, as it is related to the trunk aesthetic profile of the subjects, and besides, sagittal balance of the spine and pelvis is correlated with the progression of scoliosis. An improvement in the coronal and sagittal balance of spine resulting from wearing the Ergonomic Brace is therefore considered satisfactory.

  3. Improvement in trunk asymmetry assessed by the POTSI index

    Time frame: 0 and 6 month

    Posterior Trunk Symmetry Index (POTSI): to compare the surface topography change before and after wearing the Ergonomic Brace POTSI index: a parameter used for assessing the trunk asymmetry and deformity in the coronal plane All measurements will be performed on the 3D surface topography scans. Ideal value of POTSI is zero, meaning full asymmetry of the posterior and anterior trunk respectively.

    Normal value of POTSI should lie below 27. The performance of the Ergonomic Brace in terms of improving the trunk asymmetry of participants is considered effective when the index is scored within normal value (i.e. 0-27).

  4. Improvement in trunk asymmetry assessed by the ATSI index

    Time frame: 0 and 6 month

    Anterior Trunk Symmetry Index (ASTI): to compare the surface topography change before and after wearing the Ergonomic Brace ATSI index: a parameter used for assessing the trunk asymmetry and deformity in the frontal plane All measurements will be performed on the 3D surface topography scans. Ideal value of ATSI is zero, meaning full asymmetry of the posterior and anterior trunk respectively. Normal value, on the other hand, should lie below 27 for each index. The performance of the Ergonomic Brace in terms of improving the trunk asymmetry of participants is considered effective when the index is scored within normal value (i.e. 0-27).

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Innovation and Technology Commission, Hong Kong
  • The University of Hong Kong

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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