Adolescent Idiopathic ScoliosisNCT06500806
Impact of Long-Term Schroth Exercises on Scoliosis Severity and Quality of Life in Braced AIS Individuals
A study testing Scroth and brace and Brace in people with Adolescent Idiopathic Scoliosis, run by International Hellenic University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Scroth and brace and Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 2 Jan 2023to 28 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Any contraindication for exercise
- Scheduled surgery for scoliosis treatment
- Diagnosed intellectual disabilities (e.g., intellectual disability, autism)
- Diagnosed neurological or rheumatic conditions
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
Thessaloniki, Sindos Thessaloníki, 57 400
About this study
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
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.
Read the 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
- Being tested
- Scroth and brace, Brace
- Keywords
- Adolescent idiopathic scoliosis, Schroth exercises, Conservative treatment, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scroth and braceOther
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.
BraceDevice
Participants in this group will follow only the brace treatment
| Study group | Role | What they receive |
|---|---|---|
| Scroth and brace Group | Experimental | Participants allocated to this group will receive bracing and Schroth exercises for 12 months Receives: Other: Scroth and brace |
| Brace group | Active comparator | Participants in this group will follow brace treatment. Receives: Device: Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Pre-treatment, months: 12, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start2 Jan 2023
- Primary completion28 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500806
- Sponsor's protocol ID
- EC-09/2022
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06500806
- Acronym / sponsor ID
- EC-09/2022
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, Schroth exercises, Conservative treatment, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Scroth and brace Group | Experimental | Other: Scroth and braceParticipants allocated to this group will receive bracing and Schroth exercises for 12 months |
| Brace group | Active comparator | Device: BraceParticipants in this group will follow brace treatment. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Any contraindication for exercise
- Scheduled surgery for scoliosis treatment
- Diagnosed intellectual disabilities (e.g., intellectual disability, autism)
- Diagnosed neurological or rheumatic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scroth and braceParticipants 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. | Other | Scroth and brace Group |
| BraceParticipants in this group will follow only the brace treatment | Device | Brace group |
Primary outcome
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scroth and brace and Brace in people with Adolescent Idiopathic Scoliosis, run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cobb ankle (time frame: Pre-treatment, months: 12, 18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.