ScoliosisNCT05454800
Effects of Physical Activity Counseling in Patients With Adolescent Idiopathic Scoliosis
A study testing Scoliosis Specific Corrective Exercises and Physical Activity Counseling and Scoliosis Specific Corrective Exercises in people with Scoliosis and Adolescent Scoliosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Scoliosis is a three-dimensional deformity of the spine of unknown etiology and is clinically defined as 10° or more lateral curvature of the spine. Although there are different types of scoliosis, the most common type is adolescent idiopathic scoliosis (AIS), which starts at the age of 10. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Scoliosis, Adolescent Scoliosis
- What is being tested?
- Scoliosis Specific Corrective Exercises and Physical Activity Counseling and Scoliosis Specific Corrective Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2022to 1 Apr 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
- Being diagnosed with Idiopathic Scoliosis by an orthopedic specialist
- Cobb angle determined on anteroposterior radiograph is 10 - 45 degrees
Who cannot join
- Having mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary disease
- Any treatment approach for scoliosis in the last six months
- Having any orthopedic problems that may affect their participation in exercise and/or physical activity
- Having a regular exercise habit
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, 34000
Pelin Vural, +905344245350, pelinvural7@gmail.com
About this study
Official title: Effects of Physical Activity Counseling in Addition to Scoliosis-Specific Corrective Exercises in Patients With Adolescent Idiopathic Scoliosis
Scoliosis is a three-dimensional deformity of the spine of unknown etiology and is clinically defined as 10° or more lateral curvature of the spine. Although there are different types of scoliosis, the most common type is adolescent idiopathic scoliosis (AIS), which starts at the age of 10. AIS can affect body alignment, spine and soft tissues and cause physical problems such as postural disorder, cosmetic trunk deformity, decreased flexibility of the spinal column, changes in spinal muscle characteristics, and back pain. The aim of our study is to examine the effects of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in patients with AIS.
Read the detailed description
AIS is the most common spinal deformity seen by primary care physicians, pediatricians, and spinal surgeons. The primary goal in the conservative treatment of scoliosis in adolescents is to prevent the progression of the curvature and secondary problems associated with spinal deformity and ultimately to eliminate the need for surgery. For this reason, scoliosis-specific corrective exercise therapy given by a physiotherapist is recommended for patients with AIS. However, while this treatment is effective to the gold standard on spine and posture, its effect on physical activity is not known exactly. The aim of this study is to examine the effect of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in individuals with AIS who are given physical activity counseling in addition to scoliosis-specific corrective exercises. Individuals with AIS in both groups, in accordance with the Schroth classification, individually planned exercise program aimed at correcting and stabilizing the spine in three dimensions, in the form of 45-60 minutes sessions, 2 days a week for 8 weeks, a total of 16 sessions. Group 1 will be given physical activity counseling as well as scoliosis-specific corrective exercises. Physical activity counseling will be done face-to-face, and one-on-one interviews will be provided with each participant. Each meeting will last approximately 20-30 minutes and individuals will be encouraged to participate in more physical activity by providing alternative solutions on their physical activity habits, what they like to do or how they can access activities.
- Conditions
- Scoliosis, Adolescent Scoliosis
- Being tested
- Scoliosis Specific Corrective Exercises and Physical Activity Counseling, Scoliosis Specific Corrective Exercises
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis Specific Corrective Exercises and Physical Activity CounselingOther
Scoliosis specific corrective exercises and physical activity counseling
Scoliosis Specific Corrective ExercisesOther
Only scoliosis specific corrective exercises
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis Specific Corrective Exercises and Physical Activity Counseling | Experimental | Individuals with AIS in this group, in accordance with the Schroth classification, individually planned, aimed at correcting and stabilizing the spine in three dimensions, an exercise program will be applied in 45-60 minutes sessions, 2 days a week, for 8 weeks, a total of 16 sessions. In addition to corrective exercises specific to scoliosis, physical activity counseling will also be given. Receives: Other: Scoliosis Specific Corrective Exercises and Physical Activity Counseling |
| Scoliosis Specific Corrective Exercises | Experimental | Individuals with AIS in this group, in accordance with the Schroth classification, individually planned, aimed at correcting and stabilizing the spine in three dimensions, an exercise program will be applied in 45-60 minutes sessions, 2 days a week, for 8 weeks, a total of 16 sessions. Receives: Other: Scoliosis Specific Corrective Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Physical Activity Questionnaire for Older Children (PAQ-C) (The change between the baseline value and the post-follow-up value will be evaluated)
PAQ-C was developed to evaluate the physical activity levels of children aged 8-14 years in the last 7 days. 9 out of 10 items that make up the scale are used to calculate activity scores. The 10th item evaluates whether the child is able to engage in normal activities due to being sick in the previous week or for another reason, but item 10 is not included in the calculation of the activity score. The overall MFAQ score is the average of the scores of 9 items and ranges from 1 to 5. On average, 1 point indicates low physical activity level, and 5 points indicate high physical activity level.
Measured: Baseline, end of weeks 8 and six month follow up
Physical Activity Questionnaire for Adolescents (PAQ-A) (The change between the baseline value and the post-follow-up value will be evaluated)
PAQ-A was developed to evaluate the physical activity levels of adolescents aged 14-20 in the last 7 days. 8 out of 9 items that make up the scale are used to calculate activity scores. Item 9 assesses whether the child is able to engage in normal activities due to illness or other reasons in the previous week, but item 9 is not included in the calculation of the activity score. The overall MFAQ score is the average of the scores of 8 items and ranges from 1 to 5. On average, 1 point indicates low physical activity level, and 5 points indicate high physical activity level.
Measured: Baseline, end of weeks 8 and six month follow up
One-Week Step Count Measurement with Pedometer for Physical Activity Assessment (The change between the baseline value and the post-follow-up value will be evaluated)
It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered into the device and recorded as a step when the vertical oscillation of the body exceeds a certain threshold value. In our study, the number of steps taken by the participants during a week before and after treatment will be calculated and recorded. Higher scores better outcomes.
Measured: Baseline, end of weeks 8 and six month follow up
Secondary outcomes (4)
POsterior Trunk Symmetry Index (POTSI) (The change between the baseline value and the post-follow-up value will be evaluated)
POTSI is defined as the sum of six indices, three frontal plane asymmetry indices and three frontal plane height difference indices, in the patient's anterior and posterior photographs. Calculation is made by placing indices into the formula. While zero represents full symmetry, as the score increases, the asymmetry also increases (Stolinski et al. 2012; Patias et al. 2010). In our study, "SCODIAC" (SCOliotic DIAgnostiCs) computer program will be used for PGAI and AGAI calculations. While zero represents complete symmetry, as the score increases, so does the asymmetry.
Measured: Baseline, end of weeks 8 and six month follow up
Anterior Trunk Symmetry Index (ATSI) (The change between the baseline value and the post-follow-up value will be evaluated)
ATSI (PGAI) is defined as the sum of six indices, three frontal plane asymmetry indices and three frontal plane height difference indices, in the patient's anterior and posterior photographs. Calculation is made by placing indices into the formula. While zero represents full symmetry, as the score increases, the asymmetry also increases (Stolinski et al. 2012; Patias et al. 2010). In our study, "SCODIAC" (SCOliotic DIAgnostiCs) computer program will be used for PGAI and AGAI calculations. While zero represents complete symmetry, as the score increases, so does the asymmetry.
Measured: Baseline, end of weeks 8 and six month follow up
The Walter Reed Visual Assessment Scale (WRVAS) (The change between the baseline value and the post-follow-up value will be evaluated)
WRVAS is an easy-to-use and scoring scale that allows to understand the visual change caused by scoliosis. In WRVAS, which correlates with the degree of curvature and has high internal consistency, treatment results are evaluated under seven headings. Each deformity is scored from 1 to 5 on the scale. In our study, this scale will be filled by the physiotherapist and the individual with AIS, and the difference (dWRVAS) between the WRVAS scores of the physiotherapist and the individual with AIS will be noted. The decrease in the difference will be evaluated as an improvement in the perception of deformity. High scores indicate increased deformity.
Measured: Baseline, end of weeks 8 and six month follow up
The Scoliosis Research Society-22 Questionnaire (SRS-22) (The change between the baseline value and the post-follow-up value will be evaluated)
SRS-22 is a questionnaire designed by the Scoliosis Research Society (SRS) specifically for patients with spinal deformity. This questionnaire, which consists of 5 main titles, includes questions about pain, body image, function, mental health and satisfaction with treatment. The score for each item ranges from zero (worst) to five (best). Scores in the sections can be obtained separately by dividing the score received from each section by the number of questions in the relevant section, and the total score can be obtained by adding the scores obtained from all questions and dividing them by the total number of questions. As a result of scoring, a high score indicates an increase in quality of life.
Measured: Baseline, end of weeks 8 and six month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start7 Jul 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Vural, Istanbul University - Cerrahpasa
- Investigators
- Ayse Zengin Alpozgen, PhD, Study chair, Istanbul University-Cerrahpaşa Faculty of Health SciencesUgur Ovacık, MSc., Study chair, Istanbul University-Cerrahpaşa, Graduate Education InstituteElcin Akyurek, MSc., Study chair, Istanbul University-Cerrahpaşa, Graduate Education InstituteTurgut Akgul, MD, Study chair, Istanbul University Faculty of MedicinePelin Vural, MSc., Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454800
- Sponsor's protocol ID
- 2022-FTR9174
- Status last verified
- Jul 2022
- First submitted
- 7 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patias P, Grivas TB, Kaspiris A, Aggouris C, Drakoutos E. A review of the trunk surface metrics used as Scoliosis and other deformities evaluation indices. Scoliosis. 2010 Jun 29;5:12. doi: 10.1186/1748-7161-5-12.
PubMed 20584340Stolinski L, Kotwicki T, Czaprowski D, Chowanska J, Suzuki N. Analysis of the Anterior Trunk Symmetry Index (ATSI). Preliminary report. Stud Health Technol Inform. 2012;176:242-6.
PubMed 22744500
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity Counseling in Addition to Scoliosis-Specific Corrective Exercises in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05454800
- Acronym / sponsor ID
- 2022-FTR9174
- Conditions
- Scoliosis, Adolescent Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 12 Jul 2022 (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.
Scoliosis is a three-dimensional deformity of the spine of unknown etiology and is clinically defined as 10° or more lateral curvature of the spine. Although there are different types of scoliosis, the most common type is adolescent idiopathic scoliosis (AIS), which starts at the age of 10. AIS can affect body alignment, spine and soft tissues and cause physical problems such as postural disorder, cosmetic trunk deformity, decreased flexibility of the spinal column, changes in spinal muscle characteristics, and back pain. The aim of our study is to examine the effects of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in patients with AIS.
Detailed description
AIS is the most common spinal deformity seen by primary care physicians, pediatricians, and spinal surgeons. The primary goal in the conservative treatment of scoliosis in adolescents is to prevent the progression of the curvature and secondary problems associated with spinal deformity and ultimately to eliminate the need for surgery. For this reason, scoliosis-specific corrective exercise therapy given by a physiotherapist is recommended for patients with AIS. However, while this treatment is effective to the gold standard on spine and posture, its effect on physical activity is not known exactly. The aim of this study is to examine the effect of physical activity counseling on physical activity level and posture, perception of deformity and quality of life in individuals with AIS who are given physical activity counseling in addition to scoliosis-specific corrective exercises. Individuals with AIS in both groups, in accordance with the Schroth classification, individually planned exercise program aimed at correcting and stabilizing the spine in three dimensions, in the form of 45-60 minutes sessions, 2 days a week for 8 weeks, a total of 16 sessions. Group 1 will be given physical activity counseling as well as scoliosis-specific corrective exercises. Physical activity counseling will be done face-to-face, and one-on-one interviews will be provided with each participant. Each meeting will last approximately 20-30 minutes and individuals will be encouraged to participate in more physical activity by providing alternative solutions on their physical activity habits, what they like to do or how they can access activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis Specific Corrective Exercises and Physical Activity Counseling | Experimental | Other: Scoliosis Specific Corrective Exercises and Physical Activity CounselingIndividuals with AIS in this group, in accordance with the Schroth classification, individually planned, aimed at correcting and stabilizing the spine in three dimensions, an exercise program will be applied in 45-60 minutes sessions, 2 days a week, for 8 weeks, a total of 16 sessions. In addition to corrective exercises specific to scoliosis, physical activity counseling will also be given. |
| Scoliosis Specific Corrective Exercises | Experimental | Other: Scoliosis Specific Corrective ExercisesIndividuals with AIS in this group, in accordance with the Schroth classification, individually planned, aimed at correcting and stabilizing the spine in three dimensions, an exercise program will be applied in 45-60 minutes sessions, 2 days a week, for 8 weeks, a total of 16 sessions. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Being diagnosed with Idiopathic Scoliosis by an orthopedic specialist
- Cobb angle determined on anteroposterior radiograph is 10 - 45 degrees
Key exclusion criteria (4 listed)
- Having mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary disease
- Any treatment approach for scoliosis in the last six months
- Having any orthopedic problems that may affect their participation in exercise and/or physical activity
- Having a regular exercise habit
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 |
|---|---|---|
| Scoliosis Specific Corrective Exercises and Physical Activity CounselingScoliosis specific corrective exercises and physical activity counseling | Other | Scoliosis Specific Corrective Exercises and Physical Activity Counseling |
| Scoliosis Specific Corrective ExercisesOnly scoliosis specific corrective exercises | Other | Scoliosis Specific Corrective Exercises |
Primary outcome
The Physical Activity Questionnaire for Older Children (PAQ-C) (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
PAQ-C was developed to evaluate the physical activity levels of children aged 8-14 years in the last 7 days. 9 out of 10 items that make up the scale are used to calculate activity scores. The 10th item evaluates whether the child is able to engage in normal activities due to being sick in the previous week or for another reason, but item 10 is not included in the calculation of the activity score. The overall MFAQ score is the average of the scores of 9 items and ranges from 1 to 5. On average, 1 point indicates low physical activity level, and 5 points indicate high physical activity level.
Physical Activity Questionnaire for Adolescents (PAQ-A) (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
PAQ-A was developed to evaluate the physical activity levels of adolescents aged 14-20 in the last 7 days. 8 out of 9 items that make up the scale are used to calculate activity scores. Item 9 assesses whether the child is able to engage in normal activities due to illness or other reasons in the previous week, but item 9 is not included in the calculation of the activity score. The overall MFAQ score is the average of the scores of 8 items and ranges from 1 to 5. On average, 1 point indicates low physical activity level, and 5 points indicate high physical activity level.
One-Week Step Count Measurement with Pedometer for Physical Activity Assessment (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered into the device and recorded as a step when the vertical oscillation of the body exceeds a certain threshold value. In our study, the number of steps taken by the participants during a week before and after treatment will be calculated and recorded. Higher scores better outcomes.
4 secondary outcomes
POsterior Trunk Symmetry Index (POTSI) (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
Anterior Trunk Symmetry Index (ATSI) (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
The Walter Reed Visual Assessment Scale (WRVAS) (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
The Scoliosis Research Society-22 Questionnaire (SRS-22) (The change between the baseline value and the post-follow-up value will be evaluated)
Time frame: Baseline, end of weeks 8 and six month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 20584340Patias P, Grivas TB, Kaspiris A, Aggouris C, Drakoutos E. A review of the trunk surface metrics used as Scoliosis and other deformities evaluation indices. Scoliosis. 2010 Jun 29;5:12. doi: 10.1186/1748-7161-5-12.
- Results publication: PubMed 22744500Stolinski L, Kotwicki T, Czaprowski D, Chowanska J, Suzuki N. Analysis of the Anterior Trunk Symmetry Index (ATSI). Preliminary report. Stud Health Technol Inform. 2012;176:242-6.
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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.
Ayse Zengin Alpozgen, PhD study chair
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Ugur Ovacık, MSc. study chair
Istanbul University-Cerrahpaşa, Graduate Education Institute
Elcin Akyurek, MSc. study chair
Istanbul University-Cerrahpaşa, Graduate Education Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scoliosis Specific Corrective Exercises and Physical Activity Counseling and Scoliosis Specific Corrective Exercises in people with Scoliosis and Adolescent Scoliosis, run by Istanbul University - Cerrahpasa 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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 Ayse Zengin Alpözgen, PhD (+905526830479, azengin@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Physical Activity Questionnaire for Older Children (PAQ-C) (The change between the baseline value and the post-follow-up value will be evaluated) (time frame: Baseline, end of weeks 8 and six month follow up). 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?
On the ClinicalTrials.gov record for NCT05454800, which also lists 2 linked publications.
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 20 Jul 2022.