Adolescent Idiopathic ScoliosisNCT06187623
COMPARISON OF THE EFFECTIVENESS OF CLINICAL AND HOME-BASED SCHROTH EXERCISES ON ADOLESCENT IDIOPATHIC SCOLIOSIS INDIVIDUALS
An observational study of Adolescent Idiopathic Scoliosis, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
In individuals diagnosed with AIS, significant regressions in curvature were observed with the use of schroth exercises and brace. It is known that neurological changes affect the vestibular system and create changes in the individual's balance and proprioception. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Clinic based exercise and Home based exercise
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 4 Mar 2024
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ınviduals between the ages of 10-18 who have been diagnosed with AIS and having brace treatment given by the doctor come to our clinic.
Who may be able to join
- Being between the ages of 10-18,
- Being diagnosed with Adolescent Idiopathic Scoliosis (AIS),
- COBB angles should be between 20 and 45 degrees,
- Risser sign being between 0-5,
- Having brace treatment given by the doctor.
Who cannot join
- Having a different diagnosis such as congenital scoliosis, spina bifida, traumatic scoliosis, osteoporosis,
- Having had spine surgery,
- Stating that you will not comply with the corset period prescribed by the doctor,
- Having serious cardiopulmonary problems that will prevent them from exercising,
- Individuals and parents did not agree to sign the consent form required to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University
Istanbul, 34674
İpek Yurttaş, 05063369003, ipekyurttas@outlook.com
About this study
In individuals diagnosed with AIS, significant regressions in curvature were observed with the use of schroth exercises and brace. It is known that neurological changes affect the vestibular system and create changes in the individual's balance and proprioception. At the same time, when static and balance are examined, it is seen that they have difficulty in maintaining their dynamic balance and their body center of gravity oscillations increase. There are a limited number of studies in the literature evaluating individuals diagnosed with AIS in the combined treatment of brace use and Schroth exercises.
Read the detailed description
The purpose of this study is to compare the effectiveness of clinic and home-based Schroth exercises in individuals diagnosed with adolescent idiopathic scoliosis.
The 30 participants who will participate in the study will be between the ages of 10-18 and their Cobb angle will vary between 25-45 degrees. Consent forms will be obtained from all participants participating in the study.
Cervical Relocation Test to measure participants' proprioception; Y-Balance Test will be used for dynamic balance, evaluation of trunk rotation angle with a scoliometer, Spinal Appearence Questionnaire for cosmetic deformity perception, Bad-Sobernheim Stress Questionnaire will be used for brace stress.
Demographic information such as age (years), weight (kg), height (cm), lower extremity length (cm), primary curvatures, daily brace use time (hours), brace use frequency of the people who agreed to participate in the study were collected. corset revision The number and use of insoles (yes or not) will be questioned.
The Cervicocephalic Relocation Test developed by Revel will be used to evaluate cervical proprioception. Blindfolded subjects will be seated on a chair with a backrest, 90cm away from the wall on which a circular target board is hung. They will be asked to sit as far back in the chair as possible, placing their arms on their laps, and leaning on the back of the chair. Each subject has a laser pointer attached to their head and their eyes will be covered with a sleep mask. The person's head position will be placed on the target board by the therapist, showing the laser zero point, and 5 seconds will be given to remember this point. Subjects will experience the test with their eyes open before starting the experiment. After concentrating on this reference position for a few seconds, the patient will be asked to move the head in the previously shown directions (flexion, extension) for 5 repetitions and return to the reference point. The distance between the starting head position and the ending head position will be calculated as the angular result by placing it in the formula angle = tan -1 [Distance between the start and the end cm/90 cm].
Dynamic Balance- Y Balance Test After the foot of the party to be tested is placed behind the red line on the platform, they will be asked to push the distance indicator in all three directions (anterior, postromedial and posterolateral) as far as possible with the foot in the air. After two trials are made in each direction before the test, three measurements will be taken for each direction during the test phase. For each direction, the total score obtained by dividing the best value of the three maximum distances by the leg length and multiplying by 100 will be calculated and noted. The test will be terminated when the person lifts the heel of the tested foot standing on the platform to maintain balance during the test, loses contact with the distance indicator, uses it as support to restore the lost balance and cannot return to the starting position.
Scoliometer, individuals will be asked to stand upright, looking forward with their feet parallel and adjacent to each other, and then the individual will be told that they should lean forward with their hands and feet together, keeping their body parallel to the ground. During the evaluation, the spinous processes will be monitored with a scoliometer, starting from the cervical region to the lumbar region.
For quality of life assessment; Bad Sobernheim Stress Questionnaire and Scoliosis Appearance Questionnaire were used. Evaluations will be answered twice, before and after.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Clinic based exercise, Home based exercise
- Keywords
- scoliosis, brace, exercise, proprioception, neck
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic based exerciseOther
15 patients and their parents in the clinic-based group will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy.
Individuals in this group will be included in an exercise program 3 days a week (24 sessions) with a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 4 days of the week.
Home based exerciseOther
15 patients in the home-based group and their parents will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy.
Individuals in this group will be included in an exercise program 1 day a week (8 sessions) accompanied by a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 6 days of the week.
| Study group | Role | What they receive |
|---|---|---|
| Home based Group | 15 patients in the home-based group and their parents will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy.
Individuals in this group will be included in an exercise program 1 day a week (8 sessions) accompanied by a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 6 days of the week. Receives: Other: Home based exercise | |
| Clinic based Group | 15 patients and their parents in the clinic-based group will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy.
Individuals in this group will be included in an exercise program 3 days a week (24 sessions) with a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 4 days of the week. Receives: Other: Clinic based exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of clinical based Schroth exercises on the cervical proprioception
Individuals will be seated with their eyes closed, with the laser pointer on their heads, and will be asked to target the 0 point on the target board in front of them. After performing 5 repetitions of flexion and 5 repetitions of extension movements, deviations from the 0 point will be recorded.
Measured: 15 minutes
The effect of home based Schroth exercises on the cervical proprioception
Individuals will be seated with their eyes closed, with the laser pointer on their heads, and will be asked to target the 0 point on the target board in front of them. After performing 5 repetitions of flexion and 5 repetitions of extension movements, deviations from the 0 point will be recorded.
Measured: 15 minutes
Secondary outcomes (2)
The effect of home based Schroth exercises on the dynamic balance
The lower extremity to be evaluated is lifted onto the testing platform. It is desired to extend to the anterior, posterolateral and posteromedial directions, respectively. The longest distance it can reach is recorded.
Measured: 10 minutes
The effect of clinic based Schroth exercises on the dynamic balance
The lower extremity to be evaluated is lifted onto the testing platform. It is desired to extend to the anterior, posterolateral and posteromedial directions, respectively. The longest distance it can reach is recorded.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start15 Dec 2023
- Primary completion25 Feb 2024 (estimated)
- Study completion4 Mar 2024 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek Yurttaş, Uskudar University
- Investigators
- ipek yurttaş, Principal investigator, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187623
- Sponsor's protocol ID
- Physiotherapy rehabilitation
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECTIVENESS OF CLINICAL AND HOME-BASED SCHROTH EXERCISES ON ADOLESCENT IDIOPATHIC SCOLIOSIS INDIVIDUALS
- ClinicalTrials.gov ID
- NCT06187623
- Acronym / sponsor ID
- Physiotherapy rehabilitation
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- scoliosis, brace, exercise, proprioception, neck
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 4 Mar 2024 (estimated)
- First posted
- 2 Jan 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.
In individuals diagnosed with AIS, significant regressions in curvature were observed with the use of schroth exercises and brace. It is known that neurological changes affect the vestibular system and create changes in the individual's balance and proprioception. At the same time, when static and balance are examined, it is seen that they have difficulty in maintaining their dynamic balance and their body center of gravity oscillations increase. There are a limited number of studies in the literature evaluating individuals diagnosed with AIS in the combined treatment of brace use and Schroth exercises.
Detailed description
The purpose of this study is to compare the effectiveness of clinic and home-based Schroth exercises in individuals diagnosed with adolescent idiopathic scoliosis.
The 30 participants who will participate in the study will be between the ages of 10-18 and their Cobb angle will vary between 25-45 degrees. Consent forms will be obtained from all participants participating in the study.
Cervical Relocation Test to measure participants' proprioception; Y-Balance Test will be used for dynamic balance, evaluation of trunk rotation angle with a scoliometer, Spinal Appearence Questionnaire for cosmetic deformity perception, Bad-Sobernheim Stress Questionnaire will be used for brace stress.
Demographic information such as age (years), weight (kg), height (cm), lower extremity length (cm), primary curvatures, daily brace use time (hours), brace use frequency of the people who agreed to participate in the study were collected. corset revision The number and use of insoles (yes or not) will be questioned.
The Cervicocephalic Relocation Test developed by Revel will be used to evaluate cervical proprioception. Blindfolded subjects will be seated on a chair with a backrest, 90cm away from the wall on which a circular target board is hung. They will be asked to sit as far back in the chair as possible, placing their arms on their laps, and leaning on the back of the chair. Each subject has a laser pointer attached to their head and their eyes will be covered with a sleep mask. The person's head position will be placed on the target board by the therapist, showing the laser zero point, and 5 seconds will be given to remember this point. Subjects will experience the test with their eyes open before starting the experiment. After concentrating on this reference position for a few seconds, the patient will be asked to move the head in the previously shown directions (flexion, extension) for 5 repetitions and return to the reference point. The distance between the starting head position and the ending head position will be calculated as the angular result by placing it in the formula angle = tan -1 [Distance between the start and the end cm/90 cm].
Dynamic Balance- Y Balance Test After the foot of the party to be tested is placed behind the red line on the platform, they will be asked to push the distance indicator in all three directions (anterior, postromedial and posterolateral) as far as possible with the foot in the air. After two trials are made in each direction before the test, three measurements will be taken for each direction during the test phase. For each direction, the total score obtained by dividing the best value of the three maximum distances by the leg length and multiplying by 100 will be calculated and noted. The test will be terminated when the person lifts the heel of the tested foot standing on the platform to maintain balance during the test, loses contact with the distance indicator, uses it as support to restore the lost balance and cannot return to the starting position.
Scoliometer, individuals will be asked to stand upright, looking forward with their feet parallel and adjacent to each other, and then the individual will be told that they should lean forward with their hands and feet together, keeping their body parallel to the ground. During the evaluation, the spinous processes will be monitored with a scoliometer, starting from the cervical region to the lumbar region.
For quality of life assessment; Bad Sobernheim Stress Questionnaire and Scoliosis Appearance Questionnaire were used. Evaluations will be answered twice, before and after.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home based Group | – | Other: Home based exercise15 patients in the home-based group and their parents will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 1 day a week (8 sessions) accompanied by a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 6 days of the week. |
| Clinic based Group | – | Other: Clinic based exercise15 patients and their parents in the clinic-based group will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 3 days a week (24 sessions) with a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 4 days of the week. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ınviduals between the ages of 10-18 who have been diagnosed with AIS and having brace treatment given by the doctor come to our clinic.
Key inclusion criteria (5 listed)
- Being between the ages of 10-18,
- Being diagnosed with Adolescent Idiopathic Scoliosis (AIS),
- COBB angles should be between 20 and 45 degrees,
- Risser sign being between 0-5,
- Having brace treatment given by the doctor.
Key exclusion criteria (5 listed)
- Having a different diagnosis such as congenital scoliosis, spina bifida, traumatic scoliosis, osteoporosis,
- Having had spine surgery,
- Stating that you will not comply with the corset period prescribed by the doctor,
- Having serious cardiopulmonary problems that will prevent them from exercising,
- Individuals and parents did not agree to sign the consent form required to participate in the study.
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 |
|---|---|---|
| Clinic based exercise15 patients and their parents in the clinic-based group will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 3 days a week (24 sessions) with a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 4 days of the week. | Other | Clinic based Group |
| Home based exercise15 patients in the home-based group and their parents will be informed about the treatment program. Exercise training will be given to individuals by a physiotherapist trained in ISST- International Schroth 3-Dimensional Scoliosis Therapy. Individuals in this group will be included in an exercise program 1 day a week (8 sessions) accompanied by a physiotherapist for 8 weeks. Each exercise session will last 50 minutes. Patients will be asked to do the given home exercises on the remaining 6 days of the week. | Other | Home based Group |
Primary outcome
The effect of clinical based Schroth exercises on the cervical proprioception
Time frame: 15 minutes
Individuals will be seated with their eyes closed, with the laser pointer on their heads, and will be asked to target the 0 point on the target board in front of them. After performing 5 repetitions of flexion and 5 repetitions of extension movements, deviations from the 0 point will be recorded.
The effect of home based Schroth exercises on the cervical proprioception
Time frame: 15 minutes
Individuals will be seated with their eyes closed, with the laser pointer on their heads, and will be asked to target the 0 point on the target board in front of them. After performing 5 repetitions of flexion and 5 repetitions of extension movements, deviations from the 0 point will be recorded.
2 secondary outcomes
The effect of home based Schroth exercises on the dynamic balance
Time frame: 10 minutes
The effect of clinic based Schroth exercises on the dynamic balance
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 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.
ipek yurttaş principal investigator
Üsküdar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Uskudar University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jan 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İpek Yurttaş (05063369003, ipekyurttas@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of clinical based Schroth exercises on the cervical proprioception (time frame: 15 minutes). The study lists 2 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 2 Jan 2024.