NCT03617120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

July 25, 2018

Last Update Submit

February 11, 2020

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis braceConventional treatment for Adolescent Idiopathic ScoliosisIn-brace correctionTrunk listingVertebral rotationInterface pressure3D body scanningSurface topographyTrunk asymmetryQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Immediate in-brace correction of spinal curve

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

    2 hours

Secondary Outcomes (4)

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

    2 hours

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

    2 hours

  • Improvement in trunk asymmetry assessed by the POTSI index

    0 and 6 month

  • Improvement in trunk asymmetry assessed by the ATSI index

    0 and 6 month

Study Arms (1)

Ergonomic Brace vs hard brace

EXPERIMENTAL

Ergonomic Brace is a new design of scoliosis brace, which consists of a knit bodice as base and also resin bones, paddings, straps and a pelvic belt as auxiliaries for spinal correction. The purpose of the bones is to keep the posture of patient upright. Paddings are placed at the convex regions of the spine while straps are used to input directional force onto the paddings. Pelvic belt, on the other hand, is for stabilizing the pelvis in order to achieve an effective spinal correction. The biomechanical principles for the correction of spine has considered both the frontal and sagittal planes, where the overall brace mechanism follows the Rigo classification. Hard brace is the brace which the participants are currently using for their ongoing conservative treatment.

Device: Ergonomic Brace vs hard brace

Interventions

Ergonomic Brace vs hard braceDEVICE

Visit 1: 1. Usual check-up: standing in-brace radiograph of hard brace and doctor consultation 2. Pressure measurement of participant wearing their hard brace Visit 2: 1. Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS) 2. 3D body scanning (before wearing the Ergonomic Brace) 3. Fitting of the Ergonomic Brace 4. Pressure measurement of participant wearing the Ergonomic Brace (instant) 5. Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours) 6. 3D body scanning (after wearing the Ergonomic Brace for 2 hours) 7. Brace Questionnaire (BrQ) for the Ergonomic Brace Visit 3: 1. Standing in-brace radiograph of the Ergonomic Brace 2. Doctor consultation

Ergonomic Brace vs hard brace

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Tsim Sha Tsui, Kolwoon, 00852, Hong Kong

Location

Study Officials

  • Joanne Yip

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 6, 2018

Study Start

August 1, 2018

Primary Completion

December 31, 2019

Study Completion

January 31, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

HK(1)