Designing and manufacturing a new brace, based on trunk asymmetry and considering the efficacy on spine lateral deformation and trunk symmetry in adolescent idiopathic scoliosis

Designing and manufacturing a new brace, based on trunk asymmetry and pad pressure optimization and considering the efficacy on Cobb angle and trunk symmetry in adolescent idiopathic scoliosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180918041062N1

Enrollment

Registered

2019-02-27

Start date

2019-01-21

Completion date

Unknown

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent idiopathic scoliosis. Juvenile and adolescent idiopathic scoliosis

Interventions

Intervention 1: Intervention group: in intervention group, new brace will be designed and manufactured based on trunk asymmetry, using 3 dimensional requisition. in this group, prominent area of one

Eligibility

Sex/Gender

All

Age

10 Years to 18 Years

Inclusion criteria

Inclusion criteria: adolescents with idiopathic scoliosis higher than 25 degree who prescribed a spinal brace. Age of at least 10 year old when brace prescription 0-2 risser sign when starting treatment Before menarche or less than one year after starting menarche in girls

Exclusion criteria

Exclusion criteria: Musculo-skeletal disorder A history of treatment Perceptual disorder Skin disease Respiratory disorder

Design outcomes

Primary

Measure	Time frame
Curve correction: Is described as the amount of curve reduction after brace wearing. Timepoint: 2.5 month after brace wearing. Method of measurement: Cobb method, radiography.	—

Secondary

Measure	Time frame
Appearance symmetry index: Is a criteria to judge about the similarity and symmetry of two half of body. Timepoint: 2.5 month after brace using. Method of measurement: Area symmetry index, Profile symmetry index.;Rib cage deformity: Is described as any deformation in rib cage, which occurs after scoliosis. Timepoint: 2.5 month after brace using. Method of measurement: Vertebro-costal angle, Lateral trunk shift, Thoracic ratio index, Rib index.;Trunk deformation perception: Is described as individual perception of trunk appearance regarding amount of symmetry. Timepoint: 2.5 month after brace using. Method of measurement: Trunk appearance perception scale.;Patient satisfaction: Patient satisfaction is a measure of the extent to which a patient is content with the health care which they received from their health care provider. Timepoint: 2.5 month after brace using. Method of measurement: Patient satisfaction questionnaire.	—

Measure

Time frame

Appearance symmetry index: Is a criteria to judge about the similarity and symmetry of two half of body. Timepoint: 2.5 month after brace using. Method of measurement: Area symmetry index, Profile symmetry index.;Rib cage deformity: Is described as any deformation in rib cage, which occurs after scoliosis. Timepoint: 2.5 month after brace using. Method of measurement: Vertebro-costal angle, Lateral trunk shift, Thoracic ratio index, Rib index.;Trunk deformation perception: Is described as individual perception of trunk appearance regarding amount of symmetry. Timepoint: 2.5 month after brace using. Method of measurement: Trunk appearance perception scale.;Patient satisfaction: Patient satisfaction is a measure of the extent to which a patient is content with the health care which they received from their health care provider. Timepoint: 2.5 month after brace using. Method of measurement: Patient satisfaction questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahrbanoo Bidari

Iran University of Medical Sciences

bidarish.to12@gmail.com+98 21 2222 7124

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026