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Effect of specific Exercise with orthopedic Brace combined customized Insole in adolescents with Idiopathic Scoliosis

Therapeutic effect of specific Exercise and use of orthopedic Brace combined with 3D customized Insole in adolescents with Idiopathic Scoliosis: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-62kz97v
Enrollment
Unknown
Registered
2025-10-21
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Juvenile Idiopathic Scoliosis

Interventions

The study will have a controlled, parallel, and randomized clinical trial design in which one hundred adolescents with adolescent idiopathic scoliosis will be recruited and randomized into two interve
and a control group (n=50) consisting only of traditional conservative treatment with specific exercises and use of an orthopedic brace (n=50). The primary outcome measures will be spinopelvic paramet
and secondary outcome measures will be postural balance measured by the Baiobit system (Kinetec) and quality of life measured by the Scoliosis Research Society-22 questionnaire. Measurements will be a
E02.760.169.063.500

Sponsors

Obras Sociais e Educacionais de Luz (Universidade Santo Amaro)
Lead Sponsor
Obras Sociais e Educacionais de Luz (Universidade Santo Amaro)
Collaborator

Eligibility

Age
11 Years to 18 Years

Inclusion criteria

Inclusion criteria: Adolescents aged 11 to 18 years; diagnosis of adolescent idiopathic scoliosis; both genders

Exclusion criteria

Exclusion criteria: Symptomatic musculoskeletal diseases in the lower limbs; symptomatic diseases of the central and peripheral nervous system; diabetes mellitus; corrective surgery for spinal curvature; rigid foot deformities; injections in the feet and ankles in the last three months; previous or planned spinal surgery in the next twelve months; and mental disability

Design outcomes

Primary

MeasureTime frame
Expected outcome 1, radiographic images, Cobb angle and spine-pelvic parameters, evaluated by x-ray examination. It is expected to find an average improvement of 5% over spinopelvic parameters and Cobb angle, in pre and post-intervention measurements

Secondary

MeasureTime frame
Expected outcome 1, postural balance evaluated by the BAIBIT System (Kinetec). It is expected to find an average improvement of 10% over postural balance, in pre and post-intervention measurements;Expected outcome 2, quality of life evaluated by the scoliosis Research Society-23 questionnaire. It is expected to find an average improvement of 10% on quality of life, in pre and post-intervention measurements

Countries

Brazil

Contacts

Public ContactAna Paula Ribeiro

Universidade Santo Amaro

anapribeiro@prof.unisa.br+55-11-991392168

Outcome results

None listed

Source: REBEC (via WHO ICTRP)