Adolescent Idiopathic ScoliosisNCT06170112
Evaluation Of The Effect Of Spinal Orthosis On Tactile Sense And Balance In Individuals With Lumbal Curve And Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
In individuals with lumbar curvature, significant regressions in the curvature have been observed with spinal orthosis treatment, especially with use of a minimum of 20 hours a day. 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?
- Spinal Orthosis Application
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2023to 6 Mar 2024
- How long will I take part?
- 3 Months
- 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: Individuals between the ages of 10-18 who have been diagnosed with AIS by a doctor come to our clinic. Following clinical evaluations, a spinal orthosis evaluation will be performed. Individuals must not have used a spinal orthosis before.They should not have any accompanying neurological disease.
Who may be able to join
- Being diagnosed with Adolescent Idiopathic Scoliosis (AIS) between the ages of 10-18,
- Curvature only in the lumbar region,
- 20-45 degree curvature degree,
- Being deemed suitable for spinal orthosis use by the doctor,
- Not having used a spinal orthosis before
Who cannot join
- Having different diagnoses such as congenital scoliosis, spina bfida, traumatic scoliosis, osteoporosis,
- Having had spine surgery
- Having used a scoliosis spinal orthosis,
- Having an accompanying disease that may prevent the use of spinal orthosis and
- Failure 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
Istanbul Medipol University
Istanbul, 34722
BAŞAK İ İŞÇİOĞLU, 05319238578, iscioglubasak@gmail.com
About this study
In individuals with lumbar curvature, significant regressions in the curvature have been observed with spinal orthosis treatment, especially with use of a minimum of 20 hours a day. Symptoms such as numbness and decreased sense of touch are observed in the areas where the curvature is located, and changes in the skin structure are affected by the changes in the spine. Sensory testing may vary with changes in body posture. At the same time, the use of spinal orthosis, balance, fat mass, and the presence of pain show us sensitivity to touch on the skin. Sensory stimuli on the skin and trunk posture are interconnected. There are a limited number of studies in the literature examining the effects of sensory test results and fat mass on individuals diagnosed with AIS after using a spinal orthosis.
Read the detailed description
The purpose of this study is to examine how spinal orthoses affect lumbar curvature, tactile sensation, dynamic balance, skinfold thickness, and quality of life in people with adolescent idiopathic scoliosis. The 40 participants in the study will be between the ages of 10 and 18, with Cobb angles ranging from 20 to 45 degrees.Consent forms will be obtained from all participants and parents participating in the study.
Semmes Weinstein Monofilament kit will be used to measure participants' sense of touch, Skinfold Caliper to measure subcutaneous fat tissue, Y-Balance Test for Dynamic Balance, and Scoliosis Research Society 22 (SRS-22) Evaluation Questionnaire. Measurements will be recorded before the birth of the corset and 12 weeks after the start of corset use. At the end of the 12th week, the brace will be evaluated for satisfaction with the Brace Questionnaire (BRQ).
Socio- demographic form information will be given at the first interview. In addition to the anamnesis, this form includes questions about whether the person exercises or not, whether there is a family member diagnosed with scoliosis, and the doctor's instructions for use of the orthosis.
Sense of Touch Assessment- Semmes Weinstein Monofilament Kit will be used in the study. This test is one of the tests commonly used to evaluate light touch sensation. Although it is mostly used in the palmar area, it is also used in certain parts of the body to test light touch sensation. Semmes-Weinstein Monofilament test is performed using filaments of different diameters with the same length. The thicknesses of the filaments are 2.83, 3.22, 3.61, 3.84 and 4.31. As the filament diameter thickens, the pressure given and the sensory input given increase accordingly. In the study, in individuals diagnosed with adolescent idiopathic scoliosis and with lumbar curvature, these filaments will be applied to two different regions of the curvature, concave and convex, at T10, L4 and L5, in order from thinnest to thickest. The number of the first monofilament felt will be recorded. Pressure will be applied until the 2.83 mm monofilament, which has the thinnest diameter, is curled, the person will be asked whether he/she feels the pressure, and if not, the application will continue by increasing the filament thickness accordingly.
Fat Tissue Measurement- Skinfold Caliper thickness measurement is performed to determine the fat tissue under the skin. A significant part of the fat in the body is collected under the skin. The thickness of the skinfold is evaluated with a special caliper called skinfold. Measurement is made by holding the skin and subcutaneous tissue with the thumb and index finger and pulling the natural skin piece away from the muscle. It is read in millimeters from the caliper indicator. Measurement of the evaluated area should be done twice, and if the difference is more than 2 mm, the measurement should be repeated. The body parts measured can be listed as triceps, biceps, subscapula, suprailiaca, front of the thigh, inner side of the calf, abdomen, chest and midaxilla. It is known that low body fat is a risk factor for the onset of scoliosis. In our study, fat tissue measurements will be made in the axilla, abdominal, suscapular and suprailiac regions.
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.
Scoliosis Research Society's Health-related Quality of Life- 22 (SRS-22) survey form; It is a quality of life questionnaire created specifically for individuals diagnosed with scoliosis. It includes parameters of pain, self-appearance, function-activity, mental health, and satisfaction with treatment. It also has a role in evaluating changes within treatment. It will be filled in by the researcher together with the patient. It will be calculated by giving an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer will be scored as 1 point and the most positive answer will be scored as 5 points. All questions will be evaluated under the total result score.
Brace Questionnaire (BRQ)- Recording the evaluation of brace treatment and the feedback from the patient gives the clinician objective information about choosing the right treatment method. It consists of 34 questions grouped under 8 main headings. The domains include general health perception, physical functioning, emotional functioning, self-confidence and aesthetics, vitality, school activity, body pain, and social functioning. The score of each question (between 1 and 5) is multiplied by 20 to reach the final score, and higher scores indicate a better quality of life. Since it questions the effect of corset use on many parameters in a versatile way, it offers us an idea about the quality of life with corset in a practical and easy way.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Spinal Orthosis Application
- Keywords
- Adolescent idiopathic scoliosis, Sense of Touch, Dynamic balance, Spinal orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Orthosis ApplicationOther
Spinal orthosis treatment is to prevent secondary curvature and provide correction. Corrective pressure forces in spinal orthosis are basically; There are pressure points on the material of the spinal orthosis, pressure pads, and velcros used to adjust the tightness and ensure the stability of the orthosis. The duration of use of spinal orthoses varies from patient to patient; It is known that using it for an average of 23 hours a day gives the best results. Orthosis use is required for 12 weeks during the study.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Orthosis | There are pressure forces applied by the design of the spinal orthosis in changing the biomechanics of the scoliotic spine. In the design of the spinal orthosis designed with the 3-point principle, there is a corrective lateral force applied to the main curvature area and two support forces opposing this force. There are breathing spaces in the back area. Receives: Other: Spinal Orthosis Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of spinal orthosis on the sense of touch
Individuals between the ages of 10-18 included in the study will touch the ends of the monofilament kit, consisting of 6 different tips, to the concave and convex sections of the slope in the T10-L4 and L5 regions. The results are recorded when the individual answers "I felt it/I didn't feel it". Evaluations will be made immediately before orthosis use and 12 weeks after orthosis use.
Measured: 5 minute
Secondary outcomes (3)
Effect of spinal orthosis on 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 minute
Effect of spinal orthosis on fat tissue
The midaxilla, abdomen, subscapular and suprailiac regions to be evaluated are compressed with the thumb and index finger, and the collected skin piece is measured with a caliper.
Measured: 5 minute
The effect of spinal orthosis on quality of life
A survey is conducted to monitor individuals' spinal orthosis and health-related quality of life during the period of spinal orthosis use.
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start13 Nov 2023
- Primary completion20 Feb 2024 (estimated)
- Study completion6 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak İŞÇİOĞLU, Istanbul Medipol University Hospital
- Investigators
- Basak Iscioglu, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170112
- Sponsor's protocol ID
- Orthosis Prosthesis
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Spinal Orthosis On Tactile Sense And Balance In Individuals With Lumbal Curve And Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06170112
- Acronym / sponsor ID
- Orthosis Prosthesis
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, Sense of Touch, Dynamic balance, Spinal orthosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 6 Mar 2024 (estimated)
- First posted
- 14 Dec 2023 (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 with lumbar curvature, significant regressions in the curvature have been observed with spinal orthosis treatment, especially with use of a minimum of 20 hours a day. Symptoms such as numbness and decreased sense of touch are observed in the areas where the curvature is located, and changes in the skin structure are affected by the changes in the spine. Sensory testing may vary with changes in body posture. At the same time, the use of spinal orthosis, balance, fat mass, and the presence of pain show us sensitivity to touch on the skin. Sensory stimuli on the skin and trunk posture are interconnected. There are a limited number of studies in the literature examining the effects of sensory test results and fat mass on individuals diagnosed with AIS after using a spinal orthosis.
Detailed description
The purpose of this study is to examine how spinal orthoses affect lumbar curvature, tactile sensation, dynamic balance, skinfold thickness, and quality of life in people with adolescent idiopathic scoliosis. The 40 participants in the study will be between the ages of 10 and 18, with Cobb angles ranging from 20 to 45 degrees.Consent forms will be obtained from all participants and parents participating in the study.
Semmes Weinstein Monofilament kit will be used to measure participants' sense of touch, Skinfold Caliper to measure subcutaneous fat tissue, Y-Balance Test for Dynamic Balance, and Scoliosis Research Society 22 (SRS-22) Evaluation Questionnaire. Measurements will be recorded before the birth of the corset and 12 weeks after the start of corset use. At the end of the 12th week, the brace will be evaluated for satisfaction with the Brace Questionnaire (BRQ).
Socio- demographic form information will be given at the first interview. In addition to the anamnesis, this form includes questions about whether the person exercises or not, whether there is a family member diagnosed with scoliosis, and the doctor's instructions for use of the orthosis.
Sense of Touch Assessment- Semmes Weinstein Monofilament Kit will be used in the study. This test is one of the tests commonly used to evaluate light touch sensation. Although it is mostly used in the palmar area, it is also used in certain parts of the body to test light touch sensation. Semmes-Weinstein Monofilament test is performed using filaments of different diameters with the same length. The thicknesses of the filaments are 2.83, 3.22, 3.61, 3.84 and 4.31. As the filament diameter thickens, the pressure given and the sensory input given increase accordingly. In the study, in individuals diagnosed with adolescent idiopathic scoliosis and with lumbar curvature, these filaments will be applied to two different regions of the curvature, concave and convex, at T10, L4 and L5, in order from thinnest to thickest. The number of the first monofilament felt will be recorded. Pressure will be applied until the 2.83 mm monofilament, which has the thinnest diameter, is curled, the person will be asked whether he/she feels the pressure, and if not, the application will continue by increasing the filament thickness accordingly.
Fat Tissue Measurement- Skinfold Caliper thickness measurement is performed to determine the fat tissue under the skin. A significant part of the fat in the body is collected under the skin. The thickness of the skinfold is evaluated with a special caliper called skinfold. Measurement is made by holding the skin and subcutaneous tissue with the thumb and index finger and pulling the natural skin piece away from the muscle. It is read in millimeters from the caliper indicator. Measurement of the evaluated area should be done twice, and if the difference is more than 2 mm, the measurement should be repeated. The body parts measured can be listed as triceps, biceps, subscapula, suprailiaca, front of the thigh, inner side of the calf, abdomen, chest and midaxilla. It is known that low body fat is a risk factor for the onset of scoliosis. In our study, fat tissue measurements will be made in the axilla, abdominal, suscapular and suprailiac regions.
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.
Scoliosis Research Society's Health-related Quality of Life- 22 (SRS-22) survey form; It is a quality of life questionnaire created specifically for individuals diagnosed with scoliosis. It includes parameters of pain, self-appearance, function-activity, mental health, and satisfaction with treatment. It also has a role in evaluating changes within treatment. It will be filled in by the researcher together with the patient. It will be calculated by giving an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer will be scored as 1 point and the most positive answer will be scored as 5 points. All questions will be evaluated under the total result score.
Brace Questionnaire (BRQ)- Recording the evaluation of brace treatment and the feedback from the patient gives the clinician objective information about choosing the right treatment method. It consists of 34 questions grouped under 8 main headings. The domains include general health perception, physical functioning, emotional functioning, self-confidence and aesthetics, vitality, school activity, body pain, and social functioning. The score of each question (between 1 and 5) is multiplied by 20 to reach the final score, and higher scores indicate a better quality of life. Since it questions the effect of corset use on many parameters in a versatile way, it offers us an idea about the quality of life with corset in a practical and easy way.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Orthosis | – | Other: Spinal Orthosis ApplicationThere are pressure forces applied by the design of the spinal orthosis in changing the biomechanics of the scoliotic spine. In the design of the spinal orthosis designed with the 3-point principle, there is a corrective lateral force applied to the main curvature area and two support forces opposing this force. There are breathing spaces in the back area. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals between the ages of 10-18 who have been diagnosed with AIS by a doctor come to our clinic. Following clinical evaluations, a spinal orthosis evaluation will be performed. Individuals must not have used a spinal orthosis before.They should not have any accompanying neurological disease.
Key inclusion criteria (5 listed)
- Being diagnosed with Adolescent Idiopathic Scoliosis (AIS) between the ages of 10-18,
- Curvature only in the lumbar region,
- 20-45 degree curvature degree,
- Being deemed suitable for spinal orthosis use by the doctor,
- Not having used a spinal orthosis before
Key exclusion criteria (5 listed)
- Having different diagnoses such as congenital scoliosis, spina bfida, traumatic scoliosis, osteoporosis,
- Having had spine surgery
- Having used a scoliosis spinal orthosis,
- Having an accompanying disease that may prevent the use of spinal orthosis and
- Failure 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 |
|---|---|---|
| Spinal Orthosis ApplicationSpinal orthosis treatment is to prevent secondary curvature and provide correction. Corrective pressure forces in spinal orthosis are basically; There are pressure points on the material of the spinal orthosis, pressure pads, and velcros used to adjust the tightness and ensure the stability of the orthosis. The duration of use of spinal orthoses varies from patient to patient; It is known that using it for an average of 23 hours a day gives the best results. Orthosis use is required for 12 weeks during the study. | Other | Spinal Orthosis |
Primary outcome
The effect of spinal orthosis on the sense of touch
Time frame: 5 minute
Individuals between the ages of 10-18 included in the study will touch the ends of the monofilament kit, consisting of 6 different tips, to the concave and convex sections of the slope in the T10-L4 and L5 regions. The results are recorded when the individual answers "I felt it/I didn't feel it". Evaluations will be made immediately before orthosis use and 12 weeks after orthosis use.
3 secondary outcomes
Effect of spinal orthosis on dynamic balance
Time frame: 10 minute
Effect of spinal orthosis on fat tissue
Time frame: 5 minute
The effect of spinal orthosis on quality of life
Time frame: 20 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- 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.
Basak Iscioglu principal investigator
Medipol 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 Istanbul Medipol University Hospital 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 14 Dec 2023. 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 Basak I Iscioglu (05319238578, iscioglubasak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of spinal orthosis on the sense of touch (time frame: 5 minute). 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 14 Dec 2023.