Scoliosis IdiopathicNCT05298371
The Effect of Sitting and Standing Posture on Trunk Rotation in Patients With Idiopathic Scoliosis
An observational study of Scoliosis Idiopathic, run by Burçin Akçay at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the acute effect of activities of daily living on trunk rotation in patients with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Corrected Sitting postures, Natural / relaxed sitting postures and Corrected Standing posture
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2022to 15 Jun 2022
- How long will I take part?
- 1 Day
- 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 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with adolescent idiopathic scoliosis.
Who may be able to join
- Being diagnosed with AIS between the ages of 10-35
- Cobb angle between 20º -50º,
- To be able to continue the program to be applied,
- Not having a chronic disease that requires the use of any neurological or psychiatric medication,
- The willingness of parents and/or patients to participate in the study.
Who cannot join
- The patient has any contraindications for exercise,
- Having had previous spine surgery,
- Having a curvature of 6 or more thoracic apex,
- Having any mental problems,
- The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the acute effect of activities of daily living on trunk rotation in patients with adolescent idiopathic scoliosis.
Read the detailed description
Patients with AIS who applied to Bandırma Onyedi Eylül University Physiotherapy and Rehabilitation Department will be included in this study.
Individuals diagnosed with AIS, whose Cobb angle is between 20º -50º, who do not have any chronic diseases that require neurological or psychiatric medication, and who volunteer to participate in the study will be included. Individuals with any contraindications for exercise, previous spine surgery, thoracic apex curvature of 6 or more, mental problems, non-idiopathic scoliosis but with different causes will be excluded from the study.
To determine the demographic characteristics of the participants, age, gender, weight, height, presence of chronic disease, age at first diagnosis, exercise habits, treatments, and brace use will be questioned. The ATR will be used to measure degrees of trunk rotation to monitor the effects of treatment without radiographic evaluation.
On the first day, the demographic characteristics of the participants will be questioned, Cobb angles, Risser findings, and ATR degrees will be recorded. After the first day, all postural activities and measurements will be taken on different days (at least three days apart) not to affect the degrees of trunk rotation in patients with AIS.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Corrected Sitting postures, Natural / relaxed sitting postures, Corrected Standing posture, Natural / relaxed standing postures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrected Sitting posturesBehavioural
Change after being in Corrected Sitting postures
Natural / relaxed sitting posturesBehavioural
Change after being in relaxed sitting postures
Corrected Standing postureBehavioural
Change after being in Corrected Standing posture
Natural / relaxed standing posturesBehavioural
Change after being in relaxed standing postures
| Study group | Role | What they receive |
|---|---|---|
| Patients with adolescent idiopathic scoliosis | Patients with AIS applying to Bandırma Onyedi Eylül University Physiotherapy and Rehabilitation Department will be included in this study.
Individuals diagnosed with AIS, whose Cobb angle is between 20º -50º, who do not have any chronic disease requiring neurological or psychiatric medication, and who volunteered to participate in the study will be included. Individuals with any contraindications for exercise, previous spinal surgery, 6 or more curvature of the thoracic apex, mental problems, non-idiopathic scoliosis but with different causes will be excluded from the study. Receives: Behavioral: Corrected Sitting postures; Behavioral: Natural / relaxed sitting postures; Behavioral: Corrected Standing posture; Behavioral: Natural / relaxed standing postures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of trunk rotation (ATR)
ATR can be used to monitor the effects of treatment without radiographic evaluation. ATR measurement is done using a special inclinometer called a scoliometer. The patient is asked to lean forward with the arms relaxed. The scoliometer is placed posteriorly and the degree observed at the point of greatest gimbosity is recorded.
Measured: Change from Baseline angle of trunk rotation at 5 minutes
Demographic Characteristics
Within the scope of the demographic information form, participants' age, gender, weight, height, presence of chronic diseases, age at which they were first diagnosed, exercise habits, treatments received, brace use will be questioned.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start3 Mar 2022
- Primary completion15 May 2022
- Study completion15 Jun 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Burçin Akçay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burçin Akçay, Bandırma Onyedi Eylül University
- Investigators
- Burçin Akçay, Study director, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298371
- Sponsor's protocol ID
- B Akcay
- Status last verified
- Oct 2023
- First submitted
- 6 Mar 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sitting and Standing Posture on Trunk Rotation in Patients With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05298371
- Acronym / sponsor ID
- B Akcay
- Conditions
- Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Burçin AkçayUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 28 Mar 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.
The aim of this study is to investigate the acute effect of activities of daily living on trunk rotation in patients with adolescent idiopathic scoliosis.
Detailed description
Patients with AIS who applied to Bandırma Onyedi Eylül University Physiotherapy and Rehabilitation Department will be included in this study.
Individuals diagnosed with AIS, whose Cobb angle is between 20º -50º, who do not have any chronic diseases that require neurological or psychiatric medication, and who volunteer to participate in the study will be included. Individuals with any contraindications for exercise, previous spine surgery, thoracic apex curvature of 6 or more, mental problems, non-idiopathic scoliosis but with different causes will be excluded from the study.
To determine the demographic characteristics of the participants, age, gender, weight, height, presence of chronic disease, age at first diagnosis, exercise habits, treatments, and brace use will be questioned. The ATR will be used to measure degrees of trunk rotation to monitor the effects of treatment without radiographic evaluation.
On the first day, the demographic characteristics of the participants will be questioned, Cobb angles, Risser findings, and ATR degrees will be recorded. After the first day, all postural activities and measurements will be taken on different days (at least three days apart) not to affect the degrees of trunk rotation in patients with AIS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with adolescent idiopathic scoliosis | – | Behavioral: Corrected Sitting postures, Behavioral: Natural / relaxed sitting postures, Behavioral: Corrected Standing posture, Behavioral: Natural / relaxed standing posturesPatients with AIS applying to Bandırma Onyedi Eylül University Physiotherapy and Rehabilitation Department will be included in this study. Individuals diagnosed with AIS, whose Cobb angle is between 20º -50º, who do not have any chronic disease requiring neurological or psychiatric medication, and who volunteered to participate in the study will be included. Individuals with any contraindications for exercise, previous spinal surgery, 6 or more curvature of the thoracic apex, mental problems, non-idiopathic scoliosis but with different causes will be excluded from the study. |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with adolescent idiopathic scoliosis.
Key inclusion criteria (5 listed)
- Being diagnosed with AIS between the ages of 10-35
- Cobb angle between 20º -50º,
- To be able to continue the program to be applied,
- Not having a chronic disease that requires the use of any neurological or psychiatric medication,
- The willingness of parents and/or patients to participate in the study.
Key exclusion criteria (5 listed)
- The patient has any contraindications for exercise,
- Having had previous spine surgery,
- Having a curvature of 6 or more thoracic apex,
- Having any mental problems,
- The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrected Sitting posturesChange after being in Corrected Sitting postures | Behavioural | Patients with adolescent idiopathic scoliosis |
| Natural / relaxed sitting posturesChange after being in relaxed sitting postures | Behavioural | Patients with adolescent idiopathic scoliosis |
| Corrected Standing postureChange after being in Corrected Standing posture | Behavioural | Patients with adolescent idiopathic scoliosis |
| Natural / relaxed standing posturesChange after being in relaxed standing postures | Behavioural | Patients with adolescent idiopathic scoliosis |
Primary outcome
Angle of trunk rotation (ATR)
Time frame: Change from Baseline angle of trunk rotation at 5 minutes
ATR can be used to monitor the effects of treatment without radiographic evaluation. ATR measurement is done using a special inclinometer called a scoliometer. The patient is asked to lean forward with the arms relaxed. The scoliometer is placed posteriorly and the degree observed at the point of greatest gimbosity is recorded.
Demographic Characteristics
Time frame: Baseline
Within the scope of the demographic information form, participants' age, gender, weight, height, presence of chronic diseases, age at which they were first diagnosed, exercise habits, treatments received, brace use will be questioned.
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 13 Oct 2023.
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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.
Burçin Akçay study director
Bandırma Onyedi Eylül 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 Scoliosis Idiopathic, 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 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: finished, as of the sponsor's last update on 13 Oct 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?
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?
Angle of trunk rotation (ATR) (time frame: Change from Baseline angle of trunk rotation at 5 minutes). 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 Oct 2023.