Impact of Long-Term Schroth Exercises on Scoliosis Severity and Quality of Life in Braced AIS Individuals

NCT ID: NCT06500806

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2024-07-28

Brief Summary

Adolescent Idiopathic Scoliosis (AIS) affects individuals aged 10 to 18, leading to spinal deformity and vertebral rotation. The Schroth exercise method, combined with brace usage, has shown promise in reducing the Cobb angle and preventing further deformity. This study aims to evaluate the impact of a 12-month supervised Schroth exercise program on scoliosis severity and quality of life in adolescents with AIS. Eighty adolescents, aged 10 to 17, were divided into two groups: one group received Schroth exercises along with bracing, while the control group used only a brace. Measurements included the Cobb angle, Angle Trunk Rotation (ATR), and quality of life using the SRS-22 questionnaire, assessed at the start, after 12 months, and 18 months. Analysis used Multivariate Analysis of Covariance (MANCOVA), with p < 0.05 as the significance level. We expect that the addition of Schroth exercises to a 12-month bracing program will significantly improve scoliosis severity and quality of life.

Detailed Description

Background: Adolescent Idiopathic Scoliosis (AIS) affects individuals aged 10 to 18 and is characterized by spinal deformity in the frontal plane, three-dimensional distortion of the spine, and vertebral rotation. Exercises based on the Schroth method, along with the use of a brace, have been shown to reduce the Cobb angle and may prevent further spinal deformity.

Objective: This clinical study aims to investigate the impact of a 12-month supervised Schroth exercise program on the severity of scoliosis and the quality of life in adolescents diagnosed with AIS.

Method: In this study, 80 adolescents aged 10 to 17 with AIS who are prescribed a brace are divided into two groups: an intervention group and a control group. The intervention group participates in a supervised Schroth exercise regimen three times weekly for a year, in addition to wearing a brace. The control group uses only the brace. Measurements include the Cobb angle of the main curve, the sum of the curves via Surgimap 2.3.2.1 software, the Angle Trunk Rotation (ATR) with a scoliometer, and quality of life assessed through the SRS-22 questionnaire. These assessments are conducted at the start, after one year (12th month), and six months post-intervention (18th month). The data are analyzed using Multivariate Analysis of Covariance (MANCOVA), with statistical significance set at p < 0.05.

Expected Results: Previous studies indicate that Schroth exercises can reduce the Cobb angle and ATR in adolescents with AIS and slow the progression of spinal deformity. However, few studies have investigated the effects of Schroth exercises for periods longer than six months. It is anticipated that incorporating Schroth exercises into a 12-month brace treatment program will significantly improve both the severity of scoliosis and the quality of life for the participants.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scroth and brace Group

Participants allocated to this group will receive bracing and Schroth exercises for 12 months

Group Type: EXPERIMENTAL

Scroth and brace

Intervention Type: OTHER

Participants in this group will wear a brace and follow a 12-month Schroth exercise program three times a week. Sessions will be supervised by a physiotherapist and last 60 minutes, using equipment like foam blocks, exercise balls, and rods. Exercise intensity will gradually increase based on progress. The individualized Schroth exercises will aim to correct spinal deformity and include elongation, rotational correction, stretches, strengthening, and breathing exercises. These exercises will help patients maintain proper posture in daily activities and will be adapted to each participant's abilities, with varying difficulty and positions.

Brace group

Participants in this group will follow brace treatment.

Group Type: ACTIVE_COMPARATOR

Brace

Intervention Type: DEVICE

Participants in this group will follow only the brace treatment

Interventions

Scroth and brace

Participants in this group will wear a brace and follow a 12-month Schroth exercise program three times a week. Sessions will be supervised by a physiotherapist and last 60 minutes, using equipment like foam blocks, exercise balls, and rods. Exercise intensity will gradually increase based on progress. The individualized Schroth exercises will aim to correct spinal deformity and include elongation, rotational correction, stretches, strengthening, and breathing exercises. These exercises will help patients maintain proper posture in daily activities and will be adapted to each participant's abilities, with varying difficulty and positions.

Intervention Type: OTHER

Brace

Participants in this group will follow only the brace treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Adolescent Idiopathic Scoliosis (AIS)
• Aged 10 to 17 years, inclusive of both genders
• Cobb angle between 10° and 45°
• Risser grade between 0 and 3
• Prescribed a scoliosis brace
• Written consent from their legal guardian for participation
• Ability to attend Schroth exercise sessions for one year

Exclusion Criteria

• Any contraindication for exercise
• Scheduled surgery for scoliosis treatment
• Diagnosed intellectual disabilities (e.g., intellectual disability, autism)
• Diagnosed neurological or rheumatic conditions

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Hellenic University

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Lytras

Dimitrios Lytras, Principal Investigator, Senior Lecturer of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos Thessaloníki, Greece

Countries

Greece

Other Identifiers

EC-09/2022

Identifier Type: -

Identifier Source: org_study_id