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Completed

NCT Number: NCT06500806

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

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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos Thessaloníki, 57 400, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Scroth and brace

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

Device

Participants in this group will follow only the brace treatment

Primary outcomes

  1. Changes in Cobb ankle

    Time frame: Pre-treatment, months: 12, 18

    An independent orthopedic physician will measure the Cobb angle using Surgimap 2.3.2.1 software. For each assessment, participants will undergo a radiological examination with a full spinal X-ray taken from an anteroposterior view while standing. The study will evaluate the Cobb angle of the primary curvature (the largest curve) as well as the total sum of the Cobb angles of all identified curves.

  2. Changes in maximum Ankle Trunk Rotation

    Time frame: Pre-treatment, months: 12, 18

    The ATR (Angle of Trunk Rotation) will be measured using a scoliometer. For the ATR measurement, each participant will stand with their feet together in an upright position and perform a forward bend (Adam's forward bend test) until their back is parallel to the ground. The scoliometer will then be placed vertically along the spine at the level where the rib hump appears. In this study, the maximum ATR (ATR maximum) will be recorded.

  3. Changes in quality of life with SRS - 22 questionnaire

    Time frame: Pre-treatment, months: 12, 18

    Participants' quality of life will be evaluated using the Scoliosis Research Society 22 (SRS-22) questionnaire. The SRS-22 is the standard tool for assessing the quality of life in individuals with scoliosis, comprising 22 questions across five categories: functionality (5 questions), pain (5 questions), self-image (5 questions), mental health (5 questions), and treatment satisfaction (2 questions). Responses are rated on a Likert scale from 1 to 5. The overall score is determined by averaging the subcategory scores, ranging from 1 (lowest) to 5 (highest), with higher scores indicating better quality of life. This study will use the Greek version of the questionnaire. The total SRS-22 score will be used to measure the quality of life. The Greek version has been shown to have high reliability and validity compared to the 36-Item Short Form Survey (SF-36).

Sponsors and collaborators

Lead sponsor

International Hellenic University

Other

Registry information

Official study title

The Effect of a Long-Term Schroth Exercise Program on the Severity of Scoliosis and Quality of Life in Adolescents With Adolescent Idiopathic Scoliosis Wearing a Brace: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Aug 6, 2024

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

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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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