Adolescent Idiopathic ScoliosisNCT05761236
Pilates-Based Exercises Practised by Hybrid Telerehabilitation in Adolescent Idiopathic Scoliosis
A study testing Exercise in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to see the effect of pilates-based exercise training applied with hybrid telerehabilitation method on Cobb angle, trunk rotation angle (ATR), respiratory functions, respiratory muscle strength and functional capacity in children with AIS between the ages of 10-18 and home-based pilates… 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?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Feb 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of AIS between the ages of 10-18
- Cobb angle is between 25-50 degrees
- Desktop-laptop computers, smart phones, electronic tablets, etc., which will provide internet connection and video-conferencing facilities in the homes of the patients
- The child is not included in another treatment program that will affect the progression of scoliosis
Who cannot join
- Surgical operation in the last 3 months
- The child has a neurological, orthopedic or systemic disease that will prevent him from exercising
- Having communicative, cognitive and behavioral disorders that may cause problems in understanding commands and questions during assessment and exercises
- Exercising regularly at least 3 days a week
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bezmialem Vakıf University
Istanbul, Eyüp
Bezmialem Vakıf University
Istanbul
About this study
Official title: The Effect of Pilates-Based Exercises Practised by Hybrid Telerehabilitation on Respiratory Functions, Respiratory Muscle Strength and Functional Capacity
The aim of this study was to see the effect of pilates-based exercise training applied with hybrid telerehabilitation method on Cobb angle, trunk rotation angle (ATR), respiratory functions, respiratory muscle strength and functional capacity in children with AIS between the ages of 10-18 and home-based pilates exercise. compare its effectiveness with respect to its training. Investigators of this study think that synchronous telerehabilitation sessions added to home-based pilates exercise training in children with AIS with moderate and moderate-to-severe curves can have positive effects on the evaluation parameters examined, and the results of this study can guide the relevant physiotherapists and health professionals by adding a new perspective to the literature.
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) is defined as a deformity characterized by abnormal spinal curve formation and rotation of the vertebrae in the coronal plane in a healthy individual aged 10 years and older, without any known cause.This study aimed to investigate the effect of pilates-based exercise training applied with hybrid telerehabilitation method on Cobb angle, respiratory function, respiratory muscle strength and functional capacity in patients with AIS, including postural corrections and breathing pattern determined by curve type-localization. Within the scope of the study, 32 patients diagnosed with AIS, aged 10-18 years, were randomized and divided into education and control groups. Cobb angle measurement, trunk rotation angle measurement, respiratory function test, respiratory muscle strength, functional capacity were evaluated in all patients. Training and control groups participated in supervised sessions once a week during the first 2 weeks of exercise training processes. During these sessions, the patients were informed about the basics of pilates, the postural corrections determined according to the curve type and localization, and the respiratory principles. For the next 10 weeks, the training group took synchronous online sessions with a physiotherapist 3 days a week, and the exercises were continued at home for 4 days. The control group, on the other hand, continued the same exercises 7 days a week, home-based for 10 weeks. At the end of 12 weeks, all assessments were repeated.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Exercise
- Keywords
- Pilates, Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Sessions are consisted of scoliosis-specific pilates-based exercises.The exercises were kept constant in total content, but the bilateral or unilateral application directions, the number of repetitions for the right and left sides, and the extremities used were modified for each patient according to the localization of the major curve and the type of the curve. The taught postural corrections were requested to be maintained during all exercises. Exercises for flexibility were performed asymmetrically or symmetrically according to the chosen exercise, extremities were chosen according to the curve type, with 5 repetitions and 30 seconds for each repetition. Exercises aimed at strengthening were performed for a total of 12 repetitions, during a 5-second contraction, by arranging the number of repetitions for the right and left in line with the target muscles, again considering the curve type, and the patients were asked to rest between the exercises.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | In the first 2 weeks, sessions were held with all patients once a week. In these two sessions, the basic information of scoliosis were explained to both groups. Postural corrections were explained to the patients, including the basic elements of clinical pilates.It was stated that they should breathe towards the concave side of the major curve (weak breathing zone) during exercises and postural corrections.In the Pilates-based exercise program, sessions are planned as 10 minutes of warm-up, 10 minutes of cool-down and 40 minutes of scoliosis-specific pilates-based exercises for approximately 1 hour. Total number of exercises is 12 for one session. After a 2-week joint training week, the training group switched to hybrid type telerehabilitation and continued their exercise sessions with a physiotherapist 3 days a week via synchronous video conferences (Zoom Application) and by themselves at home on the rest of the week. Receives: Other: Exercise |
| Control group | Active comparator | In the first 2 weeks, sessions were held with all patients once a week. In these two sessions, the basic information of scoliosis were explained to both groups. Postural corrections were explained to the patients, including the basic elements of clinical pilates. It was stated that they should breathe towards the concave side of the major curve (weak breathing zone) during exercises and postural corrections.In the Pilates-based exercise program, sessions are planned as 10 minutes of warm-up, 10 minutes of cool-down and 40 minutes of scoliosis-specific pilates-based exercises for approximately 1 hour. Total number of exercises is 12 for one session.The patients in the control group continued the exercise program every day of the week for 12 weeks. Exercise lists were sent to the patients in the form of electronic booklets via an electronic communication application every week, and their continuity with the exercise program was checked with the diaries they were asked to fill in. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
When measuring the Cobb angle, the tangent lines on the radiological film are drawn from the superior end plate of the superior vertebra participating in the curvature and the inferior endplate of the lowest vertebra participating in the curvature. The angle formed at the intersection of these two lines is the Cobb angle. The evaluation was performed by the same physician before and after the treatment.
Measured: 12 weeks
Pulmonary function
Spirometry device was used in the evaluation of lung functions and measurements were carried out in accordance with ATS/ERS criteria. Before the test, the weight, height, age and gender values of the patients were recorded on the spirometer device. All of the measurements were made in the sitting position with the feet in full contact with the ground. A nose clip was used. At the beginning of the test, inspiration and expiration were requested at the tidal volume limits. Afterwards, rapid expiration was requested following the deepest possible inspiration. Care was taken to maintain the expiration time for 6 seconds without interruption. It was recorded by choosing the best of three tests that were 95% consistent with each other. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC) and peak expiratory volume (PEF) values were measured and both measured values and percentages of expected values were recorded.
Measured: 12 weeks
Respiratory muscle strength
Respiratory muscle strength was measured in accordance with ATS/ERS criteria using an electronic and portable intraoral pressure measuring device.All of the measurements were made in the sitting position with the feet in full contact with the ground. Nasal breathing was blocked with a nose clip. In order to measure the maximum inspiratory pressure (MIP), maximum expiratory maneuver was performed before the patient took the mouthpiece of the device into his mouth, and then maximal inspiration (Müller maneuver) was performed at maximum speed for 1-3 seconds. For maximum expiratory pressure measurement, the maximum inspiratory maneuver was performed before the mouthpiece of the device was taken into the mouth, and then maximal expiration (Valsalva maneuver) was performed at maximum speed for 1-3 seconds. 3 measurements were repeated for each evaluation and the highest value was recorded in "cmH2O".
Measured: 12 weeks
Functional capacity
ISWT is a test consisting of 12 levels and each level lasts 1 minute.In ISWT the walking area was arranged to be 10 meters for each shuttle. By observing the signals heard between the two cones; patients walked very slowly at first, then at an increasing speed with 3 beeps at the end of each minute. The test was terminated in cases where the test could not be continued or if a signal was received when 0.5 m or more from the cones twice consecutively. In ESWT test, peak oxygen consumption was calculated and the value corresponding to 85% of the peak VO2 was placed on the graph and the velocity was found. After the first 2-minute warm-up period of the test, the patients were asked to walk with the determined speed. In cases where the test could not be continued, the test was terminated if the signal was received 0.5 m or more from the cones twice consecutively, and if the maximum test time of 20 minutes was reached. Walking time was recorded in seconds.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Aug 2021
- Primary completion1 Nov 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sena Manzak, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761236
- Sponsor's protocol ID
- BVUaysesena02
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manzak Dursun AS, Ozyilmaz S, Ucgun H, Elmadag NM. The effect of Pilates-based exercise applied with hybrid telerehabilitation method in children with adolescent idiopathic scoliosis: A randomized clinical trial. Eur J Pediatr. 2024 Feb;183(2):759-767. doi: 10.1007/s00431-023-05340-2. Epub 2023 Nov 23.
PubMed 37993666
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates-Based Exercises Practised by Hybrid Telerehabilitation on Respiratory Functions, Respiratory Muscle Strength and Functional Capacity
- ClinicalTrials.gov ID
- NCT05761236
- Acronym / sponsor ID
- BVUaysesena02
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Pilates, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 9 Mar 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.
The aim of this study was to see the effect of pilates-based exercise training applied with hybrid telerehabilitation method on Cobb angle, trunk rotation angle (ATR), respiratory functions, respiratory muscle strength and functional capacity in children with AIS between the ages of 10-18 and home-based pilates exercise. compare its effectiveness with respect to its training. Investigators of this study think that synchronous telerehabilitation sessions added to home-based pilates exercise training in children with AIS with moderate and moderate-to-severe curves can have positive effects on the evaluation parameters examined, and the results of this study can guide the relevant physiotherapists and health professionals by adding a new perspective to the literature.
Detailed description
Adolescent Idiopathic Scoliosis (AIS) is defined as a deformity characterized by abnormal spinal curve formation and rotation of the vertebrae in the coronal plane in a healthy individual aged 10 years and older, without any known cause.This study aimed to investigate the effect of pilates-based exercise training applied with hybrid telerehabilitation method on Cobb angle, respiratory function, respiratory muscle strength and functional capacity in patients with AIS, including postural corrections and breathing pattern determined by curve type-localization. Within the scope of the study, 32 patients diagnosed with AIS, aged 10-18 years, were randomized and divided into education and control groups. Cobb angle measurement, trunk rotation angle measurement, respiratory function test, respiratory muscle strength, functional capacity were evaluated in all patients. Training and control groups participated in supervised sessions once a week during the first 2 weeks of exercise training processes. During these sessions, the patients were informed about the basics of pilates, the postural corrections determined according to the curve type and localization, and the respiratory principles. For the next 10 weeks, the training group took synchronous online sessions with a physiotherapist 3 days a week, and the exercises were continued at home for 4 days. The control group, on the other hand, continued the same exercises 7 days a week, home-based for 10 weeks. At the end of 12 weeks, all assessments were repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Other: ExerciseIn the first 2 weeks, sessions were held with all patients once a week. In these two sessions, the basic information of scoliosis were explained to both groups. Postural corrections were explained to the patients, including the basic elements of clinical pilates.It was stated that they should breathe towards the concave side of the major curve (weak breathing zone) during exercises and postural corrections.In the Pilates-based exercise program, sessions are planned as 10 minutes of warm-up, 10 minutes of cool-down and 40 minutes of scoliosis-specific pilates-based exercises for approximately 1 hour. Total number of exercises is 12 for one session. After a 2-week joint training week, the training group switched to hybrid type telerehabilitation and continued their exercise sessions with a physiotherapist 3 days a week via synchronous video conferences (Zoom Application) and by themselves at home on the rest of the week. |
| Control group | Active comparator | Other: ExerciseIn the first 2 weeks, sessions were held with all patients once a week. In these two sessions, the basic information of scoliosis were explained to both groups. Postural corrections were explained to the patients, including the basic elements of clinical pilates. It was stated that they should breathe towards the concave side of the major curve (weak breathing zone) during exercises and postural corrections.In the Pilates-based exercise program, sessions are planned as 10 minutes of warm-up, 10 minutes of cool-down and 40 minutes of scoliosis-specific pilates-based exercises for approximately 1 hour. Total number of exercises is 12 for one session.The patients in the control group continued the exercise program every day of the week for 12 weeks. Exercise lists were sent to the patients in the form of electronic booklets via an electronic communication application every week, and their continuity with the exercise program was checked with the diaries they were asked to fill in. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of AIS between the ages of 10-18
- Cobb angle is between 25-50 degrees
- Desktop-laptop computers, smart phones, electronic tablets, etc., which will provide internet connection and video-conferencing facilities in the homes of the patients
- The child is not included in another treatment program that will affect the progression of scoliosis
Key exclusion criteria (4 listed)
- Surgical operation in the last 3 months
- The child has a neurological, orthopedic or systemic disease that will prevent him from exercising
- Having communicative, cognitive and behavioral disorders that may cause problems in understanding commands and questions during assessment and exercises
- Exercising regularly at least 3 days a week
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 |
|---|---|---|
| ExerciseSessions are consisted of scoliosis-specific pilates-based exercises.The exercises were kept constant in total content, but the bilateral or unilateral application directions, the number of repetitions for the right and left sides, and the extremities used were modified for each patient according to the localization of the major curve and the type of the curve. The taught postural corrections were requested to be maintained during all exercises. Exercises for flexibility were performed asymmetrically or symmetrically according to the chosen exercise, extremities were chosen according to the curve type, with 5 repetitions and 30 seconds for each repetition. Exercises aimed at strengthening were performed for a total of 12 repetitions, during a 5-second contraction, by arranging the number of repetitions for the right and left in line with the target muscles, again considering the curve type, and the patients were asked to rest between the exercises. | Other | Control group, Training group |
Primary outcome
Cobb angle
Time frame: 12 weeks
When measuring the Cobb angle, the tangent lines on the radiological film are drawn from the superior end plate of the superior vertebra participating in the curvature and the inferior endplate of the lowest vertebra participating in the curvature. The angle formed at the intersection of these two lines is the Cobb angle. The evaluation was performed by the same physician before and after the treatment.
Pulmonary function
Time frame: 12 weeks
Spirometry device was used in the evaluation of lung functions and measurements were carried out in accordance with ATS/ERS criteria. Before the test, the weight, height, age and gender values of the patients were recorded on the spirometer device. All of the measurements were made in the sitting position with the feet in full contact with the ground. A nose clip was used. At the beginning of the test, inspiration and expiration were requested at the tidal volume limits. Afterwards, rapid expiration was requested following the deepest possible inspiration. Care was taken to maintain the expiration time for 6 seconds without interruption. It was recorded by choosing the best of three tests that were 95% consistent with each other. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC) and peak expiratory volume (PEF) values were measured and both measured values and percentages of expected values were recorded.
Respiratory muscle strength
Time frame: 12 weeks
Respiratory muscle strength was measured in accordance with ATS/ERS criteria using an electronic and portable intraoral pressure measuring device.All of the measurements were made in the sitting position with the feet in full contact with the ground. Nasal breathing was blocked with a nose clip. In order to measure the maximum inspiratory pressure (MIP), maximum expiratory maneuver was performed before the patient took the mouthpiece of the device into his mouth, and then maximal inspiration (Müller maneuver) was performed at maximum speed for 1-3 seconds. For maximum expiratory pressure measurement, the maximum inspiratory maneuver was performed before the mouthpiece of the device was taken into the mouth, and then maximal expiration (Valsalva maneuver) was performed at maximum speed for 1-3 seconds. 3 measurements were repeated for each evaluation and the highest value was recorded in "cmH2O".
Functional capacity
Time frame: 12 weeks
ISWT is a test consisting of 12 levels and each level lasts 1 minute.In ISWT the walking area was arranged to be 10 meters for each shuttle. By observing the signals heard between the two cones; patients walked very slowly at first, then at an increasing speed with 3 beeps at the end of each minute. The test was terminated in cases where the test could not be continued or if a signal was received when 0.5 m or more from the cones twice consecutively. In ESWT test, peak oxygen consumption was calculated and the value corresponding to 85% of the peak VO2 was placed on the graph and the velocity was found. After the first 2-minute warm-up period of the test, the patients were asked to walk with the determined speed. In cases where the test could not be continued, the test was terminated if the signal was received 0.5 m or more from the cones twice consecutively, and if the maximum test time of 20 minutes was reached. Walking time was recorded in seconds.
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 9 Mar 2023.
- Derived from this study: PubMed 37993666Manzak Dursun AS, Ozyilmaz S, Ucgun H, Elmadag NM. The effect of Pilates-based exercise applied with hybrid telerehabilitation method in children with adolescent idiopathic scoliosis: A randomized clinical trial. Eur J Pediatr. 2024 Feb;183(2):759-767. doi: 10.1007/s00431-023-05340-2. Epub 2023 Nov 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 2 sites 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 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Cobb angle (time frame: 12 weeks). The study lists 4 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 NCT05761236, which also lists 1 linked publication.
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 9 Mar 2023.