An interventional study of Scroth and brace and Brace in Adolescent Idiopathic Scoliosis, sponsored by International Hellenic University. Completed at 1 site in Greece. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by International Hellenic University · Not applicable, Interventional, and Treatment
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.
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 80 is above the median of 44 across 344 interventional studies indexed under Scoliosis.
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Exclusion Criteria:
Participants allocated to this group will receive bracing and Schroth exercises for 12 months
Other: Scroth and brace
Participants in this group will follow brace treatment.
Device: 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.
Participants in this group will follow only the brace treatment
Changes in Cobb ankle
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.
Time frame: Pre-treatment, months: 12, 18
Changes in maximum Ankle Trunk Rotation
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.
Time frame: Pre-treatment, months: 12, 18
Changes in quality of life with SRS - 22 questionnaire
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).
Time frame: Pre-treatment, months: 12, 18
Plan to share: No
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International Hellenic University