Adolescent Idiopathic ScoliosisNCT04921813
Investigation of Conservative Treatment on Adolescent Idiopathic Scoliosis Patients.
A study testing 3 dimensional scoliosis exercise, Balance Exercise and Brace treatment in people with Adolescent Idiopathic Scoliosis, run by Bandırma Onyedi Eylül University.
Trial summary
Aim: It was aimed to investigate the effectiveness of three-dimensional scoliosis exercises and balance-coordination exercises in patients with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- 3 dimensional scoliosis exercise, Balance Exercise and Brace treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2014to 15 Dec 2017
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being diagnosed with adolescent idiopathic scoliosis between the ages of 10-16 and being deemed appropriate for brace use,
- Cobb angle between 20º -50º,
- To be able to continue the program to be applied,
- Not having a chronic disease that requires the use of any neurological or psychiatric medication, Hearing test results are within normal values,
- Parents allow the child to participate in the study
Who cannot join
- The patient has any contraindications to exercise,
- Previous spine surgery,
- Having a curvature of thoracic apex 6 or more,
- Having any mental problems,
- Scoliosis is not idiopathic but has occurred for different reasons (neurological, congenital, etc.),
- Presence of neurological, psychiatric, muscular, rheumatic or orthopedic diseases.
About this study
Official title: Investigation of the Efficiency of Three Dimensional Scoliosis Exercises and Balance-Coordination Exercises in the Conservative Treatment of Adolescent Idiopathic Scoliosis Patients.
Aim: It was aimed to investigate the effectiveness of three-dimensional scoliosis exercises and balance-coordination exercises in patients with adolescent idiopathic scoliosis.
Read the detailed description
Method: Thirty patients who were diagnosed with adolescent idiopathic scoliosis were randomly divided into three groups. The first group was treated with 3-dimensional scoliosis exercise program according to Schroth method, second group was treated with Schroth exercises and balance-coordination exercises in addition to brace. Exercises were performed for a total of 6 weeks (18 sessions). The third group was treated only with brace and the control group consisted of healthy individuals. Patients were assessed for their curve angle (Cobb method), rotation angle (scoliometer), spinal flexibility (anterior and lateral bending tests), quality of life (Scoliosis Research Society-22), cosmetic effects (Walter Reed Visual Rating Scale), balance parameters (Balance Master System NeuroCom International Inc. Clackamas, OR, USA ver 8.1), vertical perception (Subjective Vertical Detection test) and brain responses (electroencephalography) were assessed before and after treatment. SPSS 20.0 statistical program was used for data analysis of the study.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- 3 dimensional scoliosis exercise, Balance Exercise, Brace treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dimensional scoliosis exerciseOther
Schroth exercises
Balance ExerciseOther
Balance-coordination exercises
Brace treatmentOther
Brace usage
| Study group | Role | What they receive |
|---|---|---|
| Schroth method + brace | Experimental | 3-dimensional scoliosis exercise program according to Schroth method + brace. Receives: Other: 3 dimensional scoliosis exercise; Other: Brace treatment |
| Schroth + balance-coordination exercises + brace. | Experimental | 3-dimensional scoliosis exercise program according to Schroth + balance-coordination exercises + brace. Receives: Other: 3 dimensional scoliosis exercise; Other: Balance Exercise; Other: Brace treatment |
| Brace | Experimental | Only brace treatment. Receives: Other: Brace treatment |
| healthy individuals | No intervention | Age-matched control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance and postural control parameters -Weight Bearing/Squat
Weight Bearing/Squat (percentage, %): Weight bearing percentages of the right and left feet were measured at 0°, 30°, 60°, 90° knee flexion.
Measured: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
Cobb Angle
Cobb Angle (degree): The degree of curvature in the coronal plane is measured radiographically according to the Cobb method
Measured: Change from baseline Cobb angle at 1 year
Angle of Trunk Rotation
ATR - Angle of Trunk Rotation (degree): Measurement of trunk rotation angle/degree is the most appropriate method used in the clinical evaluation of scoliosis.
Measured: Change from baseline Angle of Trunk Rotation at 6 weeks, Change from baseline Angle of Trunk Rotation at 1 year, Change from 6th weeks Angle of Trunk Rotation at 1 year
Evaluation of subjective visual vertical perception
Evaluation of subjective visual vertical perception (degree): Subjects were asked to manually verticalize the deviated laser line projected on a wall 1 m away in a room that is dark enough to prevent them from taking visual references while standing. Photographs were recorded during this process.
Measured: Change from baseline subjective visual vertical perception at 6 weeks, Change from baseline subjective visual vertical perception at 1 year, Change from 6th weeks subjective visual vertical perception at 1 year
Electroencephalography (EEG)
In EEG recordings, epochs of 1000 ms before and 1000 ms after the stimulus were created. In these sweeps, those with amplitudes greater than ±50 μV in the EOG electrode channels and those with noise were removed. The files obtained for each individual were baseline corrected and filtered with a digital bandpass filter with 0.5 - 48 Hz limit values (12 dB/oct and zero phase shift, Neuroscan 4.5 ). After the filtering process, the mean (average) file was created for each individual.
In measuring the amplitudes of the electrophysiological responses, the responses with the largest amplitudes between 0-1000 ms were measured and evaluated in µV. EEG recordings were taken from 64 channels. However, PO3, POZ and PO4 electrodes in the parieto-occipital region were investigated as these are the primary areas for visual stimuli.
Measured: Change from baseline EEG at 6 weeks
The Dicotic Listening Paradigm:
There are 30 different (heteronymous) and 6 identical (homonymous) combinations for syllables. It was applied at 78.9 dB SPL (sound pressure level) in dichotic application. . Three rounds, with an average session duration of 7.5 minutes, and a total of approximately 25-30 minutes of test with intervals. In the dichotic application, the participants were first asked to respond without paying attention to any of their ears (non-forced/NF). In the following session, the participants were told to direct their attention to their right ear (forced right ear attention/FR) and to direct their attention to their left ear (forced left ear attention/FL).
Measured: Change from baseline The Dicotic Listening Paradigm parameters at 6 weeks
Assessment of health-related quality of life
The Scoliosis Research Society - 22 questionnaire (SRS-22) is a health-related quality of life questionnaire designed specifically for patients with spinal deformities. SRS-22 consists of the sub-headings of function, pain, body image, mental health and satisfaction with treatment and includes 22 questions in total.
Measured: Change from baseline The Scoliosis Research Society - 22 questionnaire at 6 weeks, Change from baseline The Scoliosis Research Society - 22 questionnaire at 1 year, Change from 6th weeks The Scoliosis Research Society - 22 questionnaire at 1 year
Balance and postural control parameters-Modified Clinical test of Sensory Interaction on Balance
Modified Clinical test of Sensory Interaction on Balance (degrees per second,°/sn): Body center of gravity is expressed as the ratio of swing speed and distance to time. Body center of gravity is the ratio between distance traveled (expressed in degrees) and trial time (10 sn).
Average body center of gravity swing rate (degrees per second) i) Eyes open on hard ground, ii) Eyes closed on hard ground, iii) On soft ground, eyes open and iv) It was measured in four different situations with eyes closed on soft ground.
Measured: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
Balance and postural control parameters-Limit of stability
Limit of stability (% and °/sn): It is used to determine the limits of body stability. Reaction time (sec), movement speed (degrees / sec), end point reached (%), maximum end point (%) in 8 directions: front, right front, right, right back, rear, left back, left, left front and measurements were taken in terms of directional control (%).
Measured: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start15 Aug 2014
- Primary completion15 Apr 2017
- Study completion15 Dec 2017
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
- rondomized controlled trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Akçay, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921813
- Sponsor's protocol ID
- BandırmaOnyediEylulU
- Status last verified
- Jun 2021
- First submitted
- 7 Feb 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficiency of Three Dimensional Scoliosis Exercises and Balance-Coordination Exercises in the Conservative Treatment of Adolescent Idiopathic Scoliosis Patients.
- ClinicalTrials.gov ID
- NCT04921813
- Acronym / sponsor ID
- BandırmaOnyediEylulU
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 15 Aug 2014 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 10 Jun 2021 (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.
Aim: It was aimed to investigate the effectiveness of three-dimensional scoliosis exercises and balance-coordination exercises in patients with adolescent idiopathic scoliosis.
Detailed description
Method: Thirty patients who were diagnosed with adolescent idiopathic scoliosis were randomly divided into three groups. The first group was treated with 3-dimensional scoliosis exercise program according to Schroth method, second group was treated with Schroth exercises and balance-coordination exercises in addition to brace. Exercises were performed for a total of 6 weeks (18 sessions). The third group was treated only with brace and the control group consisted of healthy individuals. Patients were assessed for their curve angle (Cobb method), rotation angle (scoliometer), spinal flexibility (anterior and lateral bending tests), quality of life (Scoliosis Research Society-22), cosmetic effects (Walter Reed Visual Rating Scale), balance parameters (Balance Master System NeuroCom International Inc. Clackamas, OR, USA ver 8.1), vertical perception (Subjective Vertical Detection test) and brain responses (electroencephalography) were assessed before and after treatment. SPSS 20.0 statistical program was used for data analysis of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- rondomized controlled trail
| Arm | Type | Receives |
|---|---|---|
| Schroth method + brace | Experimental | Other: 3 dimensional scoliosis exercise, Other: Brace treatment3-dimensional scoliosis exercise program according to Schroth method + brace. |
| Schroth + balance-coordination exercises + brace. | Experimental | Other: 3 dimensional scoliosis exercise, Other: Balance Exercise, Other: Brace treatment3-dimensional scoliosis exercise program according to Schroth + balance-coordination exercises + brace. |
| Brace | Experimental | Other: Brace treatmentOnly brace treatment. |
| healthy individuals | No intervention | –Age-matched control group |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being diagnosed with adolescent idiopathic scoliosis between the ages of 10-16 and being deemed appropriate for brace use,
- Cobb angle between 20º -50º,
- To be able to continue the program to be applied,
- Not having a chronic disease that requires the use of any neurological or psychiatric medication, Hearing test results are within normal values,
- Parents allow the child to participate in the study
Key exclusion criteria (6 listed)
- The patient has any contraindications to exercise,
- Previous spine surgery,
- Having a curvature of thoracic apex 6 or more,
- Having any mental problems,
- Scoliosis is not idiopathic but has occurred for different reasons (neurological, congenital, etc.),
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 |
|---|---|---|
| 3 dimensional scoliosis exerciseSchroth exercises | Other | Schroth + balance-coordination exercises + brace., Schroth method + brace |
| Balance ExerciseBalance-coordination exercises | Other | Schroth + balance-coordination exercises + brace. |
| Brace treatmentBrace usage | Other | Brace, Schroth + balance-coordination exercises + brace., Schroth method + brace |
Primary outcome
Balance and postural control parameters -Weight Bearing/Squat
Time frame: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
Weight Bearing/Squat (percentage, %): Weight bearing percentages of the right and left feet were measured at 0°, 30°, 60°, 90° knee flexion.
Cobb Angle
Time frame: Change from baseline Cobb angle at 1 year
Cobb Angle (degree): The degree of curvature in the coronal plane is measured radiographically according to the Cobb method
Angle of Trunk Rotation
Time frame: Change from baseline Angle of Trunk Rotation at 6 weeks, Change from baseline Angle of Trunk Rotation at 1 year, Change from 6th weeks Angle of Trunk Rotation at 1 year
ATR - Angle of Trunk Rotation (degree): Measurement of trunk rotation angle/degree is the most appropriate method used in the clinical evaluation of scoliosis.
Evaluation of subjective visual vertical perception
Time frame: Change from baseline subjective visual vertical perception at 6 weeks, Change from baseline subjective visual vertical perception at 1 year, Change from 6th weeks subjective visual vertical perception at 1 year
Evaluation of subjective visual vertical perception (degree): Subjects were asked to manually verticalize the deviated laser line projected on a wall 1 m away in a room that is dark enough to prevent them from taking visual references while standing. Photographs were recorded during this process.
Electroencephalography (EEG)
Time frame: Change from baseline EEG at 6 weeks
In EEG recordings, epochs of 1000 ms before and 1000 ms after the stimulus were created. In these sweeps, those with amplitudes greater than ±50 μV in the EOG electrode channels and those with noise were removed. The files obtained for each individual were baseline corrected and filtered with a digital bandpass filter with 0.5 - 48 Hz limit values (12 dB/oct and zero phase shift, Neuroscan 4.5 ). After the filtering process, the mean (average) file was created for each individual. In measuring the amplitudes of the electrophysiological responses, the responses with the largest amplitudes between 0-1000 ms were measured and evaluated in µV. EEG recordings were taken from 64 channels. However, PO3, POZ and PO4 electrodes in the parieto-occipital region were investigated as these are the primary areas for visual stimuli.
The Dicotic Listening Paradigm:
Time frame: Change from baseline The Dicotic Listening Paradigm parameters at 6 weeks
There are 30 different (heteronymous) and 6 identical (homonymous) combinations for syllables. It was applied at 78.9 dB SPL (sound pressure level) in dichotic application. . Three rounds, with an average session duration of 7.5 minutes, and a total of approximately 25-30 minutes of test with intervals. In the dichotic application, the participants were first asked to respond without paying attention to any of their ears (non-forced/NF). In the following session, the participants were told to direct their attention to their right ear (forced right ear attention/FR) and to direct their attention to their left ear (forced left ear attention/FL).
Assessment of health-related quality of life
Time frame: Change from baseline The Scoliosis Research Society - 22 questionnaire at 6 weeks, Change from baseline The Scoliosis Research Society - 22 questionnaire at 1 year, Change from 6th weeks The Scoliosis Research Society - 22 questionnaire at 1 year
The Scoliosis Research Society - 22 questionnaire (SRS-22) is a health-related quality of life questionnaire designed specifically for patients with spinal deformities. SRS-22 consists of the sub-headings of function, pain, body image, mental health and satisfaction with treatment and includes 22 questions in total.
Balance and postural control parameters-Modified Clinical test of Sensory Interaction on Balance
Time frame: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
Modified Clinical test of Sensory Interaction on Balance (degrees per second,°/sn): Body center of gravity is expressed as the ratio of swing speed and distance to time. Body center of gravity is the ratio between distance traveled (expressed in degrees) and trial time (10 sn). Average body center of gravity swing rate (degrees per second) i) Eyes open on hard ground, ii) Eyes closed on hard ground, iii) On soft ground, eyes open and iv) It was measured in four different situations with eyes closed on soft ground.
Balance and postural control parameters-Limit of stability
Time frame: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year
Limit of stability (% and °/sn): It is used to determine the limits of body stability. Reaction time (sec), movement speed (degrees / sec), end point reached (%), maximum end point (%) in 8 directions: front, right front, right, right back, rear, left back, left, left front and measurements were taken in terms of directional control (%).
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 10 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Adolescent Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dimensional scoliosis exercise, Balance Exercise and Brace treatment in people with Adolescent Idiopathic Scoliosis, run by Bandırma Onyedi Eylül University.
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 6 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Balance and postural control parameters -Weight Bearing/Squat (time frame: Change from baseline balance and postural control parameters at 6 weeks, Change from baseline balance and postural control parameters at 1 year, Change from 6th weeks balance and postural control parameters at 1 year). The study lists 9 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 10 Jun 2021.