Scoliosis IdiopathicNCT06875453
De Tethering Exercises for Scolisis
A study testing Exercise in people with Scoliosis Idiopathic and Exercise, run by Burçin Akçay at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis. H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 30 years, women only
- Conditions the study is for
- Scoliosis Idiopathic, Exercise, Muscle Tone
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between the ages of 10-30,
- Being diagnosed with IS
- Cobb angle between 20º and 50º,
- To be able to continue the program to be implemented,
- No chronic disease requiring the use of any neurological or psychiatric medication,
- Parents and/or child volunteering to participate in the study.
Who cannot join
- The patient has any contra-indication for exercise,
- Previous spine surgery,
- Having a curve with an apex thoracic 6 and above,
- The presence of any mental problem,
- Scoliosis is not idiopathic but has different causes (neurological, congenital, etc...), neurological, psychiatric, muscular, rheumatic or orthopedic diseases are present.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation,
Bandırma
About this study
Official title: The Effect of De-tethering Exercises on Muscle Tone in Patients with Adolescent Idiopathic Scoliosis
This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis.
H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis.
Read the detailed description
This study is planned to include 15 patients diagnosed with adolescent idiopathic scoliosis.
Muscle tone and trunk rotation degree will be measured before and after the application of detethering exercises.
- Conditions
- Scoliosis Idiopathic, Exercise, Muscle Tone
- Being tested
- Exercise
- Keywords
- scoliosis, exercise, muscle tone
- Medical subject headings
- Motor Activity, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The Schroth Best Practice program, which is widely used in the conservative treatment of scoliosis, consists of 6 modules including physiological exercises to correct the sagittal plane, activities of daily living, 3D correction techniques, powerful Schroth exercises, de-tethering exercises and gait rehabilitation. Detethering exercises in this program will be performed in this study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Detethering exercises will be performed for participants with adolescent idiopathic scoliosis. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATR - Angle of Trunk Rotation
Measurement of the angle/degree of trunk rotation is the most appropriate method for the clinical evaluation of scoliosis. ATR can be used to monitor the effects of treatment without radiographic evaluation. ATR is measured using a special inclinometer called a scoliometer. The patient is asked to lean forward with arms relaxed. The scoliometer is placed on the back and the degree observed at each point of maximum gibbosity is recorded.
Measured: 1 week
Muscle Tone
Intramuscular mechanical properties can be measured with the MyotonPRO device (Myoton Ltd., Estonia), a new diagnostic evaluation method, which measures intramuscular tension or resting muscle tone, muscle compliance, and muscle elasticity. In this study, it was shown that in conditions where electromyographic measurements are not possible, MyotonPRO measurements (viscoelastic and biomechanical properties) are used as an alternative to muscle strength and activation. The device is held upright and downward pressure is applied. When the red light on the plexiglass frame of the device probe turns green, the pressure application is stopped and the device is held stationary until 5 strokes are performed. Standard stroke intervals are used in all evaluations. During the application, care is taken to move the device and maintain the correct position. Measurements will be repeated 3 times and averaged.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Jul 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burçin Akçay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burçin Akçay, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875453
- Sponsor's protocol ID
- De tethering exercises
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of De-tethering Exercises on Muscle Tone in Patients with Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06875453
- Acronym / sponsor ID
- De tethering exercises
- Conditions
- Scoliosis Idiopathic, Exercise, Muscle Tone
- Keywords
- scoliosis, exercise, muscle tone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Burçin AkçayUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 13 Mar 2025 (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.
This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis.
H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis.
Detailed description
This study is planned to include 15 patients diagnosed with adolescent idiopathic scoliosis.
Muscle tone and trunk rotation degree will be measured before and after the application of detethering exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ExerciseDetethering exercises will be performed for participants with adolescent idiopathic scoliosis. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Be between the ages of 10-30,
- Being diagnosed with IS
- Cobb angle between 20º and 50º,
- To be able to continue the program to be implemented,
- No chronic disease requiring the use of any neurological or psychiatric medication,
Key exclusion criteria (5 listed)
- The patient has any contra-indication for exercise,
- Previous spine surgery,
- Having a curve with an apex thoracic 6 and above,
- The presence of any mental problem,
- Scoliosis is not idiopathic but has different causes (neurological, congenital, etc...), neurological, psychiatric, muscular, rheumatic or orthopedic diseases are present.
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 |
|---|---|---|
| ExerciseThe Schroth Best Practice program, which is widely used in the conservative treatment of scoliosis, consists of 6 modules including physiological exercises to correct the sagittal plane, activities of daily living, 3D correction techniques, powerful Schroth exercises, de-tethering exercises and gait rehabilitation. Detethering exercises in this program will be performed in this study. | Other | Intervention |
Primary outcome
ATR - Angle of Trunk Rotation
Time frame: 1 week
Measurement of the angle/degree of trunk rotation is the most appropriate method for the clinical evaluation of scoliosis. ATR can be used to monitor the effects of treatment without radiographic evaluation. ATR is measured using a special inclinometer called a scoliometer. The patient is asked to lean forward with arms relaxed. The scoliometer is placed on the back and the degree observed at each point of maximum gibbosity is recorded.
Muscle Tone
Time frame: 1 week
Intramuscular mechanical properties can be measured with the MyotonPRO device (Myoton Ltd., Estonia), a new diagnostic evaluation method, which measures intramuscular tension or resting muscle tone, muscle compliance, and muscle elasticity. In this study, it was shown that in conditions where electromyographic measurements are not possible, MyotonPRO measurements (viscoelastic and biomechanical properties) are used as an alternative to muscle strength and activation. The device is held upright and downward pressure is applied. When the red light on the plexiglass frame of the device probe turns green, the pressure application is stopped and the device is held stationary until 5 strokes are performed. Standard stroke intervals are used in all evaluations. During the application, care is taken to move the device and maintain the correct position. Measurements will be repeated 3 times and averaged.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Scoliosis Idiopathic and Exercise, run by Burçin Akçay 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 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
ATR - Angle of Trunk Rotation (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.