Clinical trial NCT06500806: Impact of Long-Term Schroth Exercises on Scoliosis Severity and Quality of Life in Braced AIS Individuals
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent idiopathic scoliosis
Schroth exercises
Conservative treatment
Physiotherapy
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized clinical trial will be under the supervision of the Department of Physiotherapy at the School of Health Sciences, International Hellenic University. Participants will be adolescents aged 10 to 17 years with mild to moderate scoliosis (Cobb angle from 10° to 45°) who will be prescribed a brace. The participants will be randomly assigned to two groups. The intervention group will follow a supervised Schroth exercise program alongside brace use for 12 months, with sessions three times a week. The control group will receive only brace treatment and recommendations for physical activity. The intervention will last one year, with a follow-up six months after the end of the intervention (18th month)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Cobb ankle
timeFrame: Pre-treatment, months: 12, 18
measure: Changes in maximum Ankle Trunk Rotation
timeFrame: Pre-treatment, months: 12, 18
measure: Changes in quality of life with SRS - 22 questionnaire
timeFrame: Pre-treatment, months: 12, 18
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
state: Sindos Thessaloníki
Study officials:
References: