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

NCT06500806 | Completed

• 1 other identifier: EC-09/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent idiopathic scoliosis; Schroth exercises; Conservative treatment; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Pre-treatment, months: 12, 18

Study Arms (2)

Scroth and brace Group

EXPERIMENTAL

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

Other: Scroth and brace

Brace group

ACTIVE COMPARATOR

Participants in this group will follow brace treatment.

Device: Brace

Interventions

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.

Scroth and brace Group

Brace DEVICE

Participants in this group will follow only the brace treatment

Brace group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos Thessaloníki, 57 400, Greece

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A masked assessor will conduct the measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dimitrios Lytras, Principal Investigator, Senior Lecturer of Physiotherapy

Model Details: 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)

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: January 2, 2023
• Primary Completion: July 28, 2024
• Study Completion: July 28, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)