Scoliosis IdiopathicNCT06347419
Body Awareness and Spinal Stability in Scoliosis
An observational study of Scoliosis Idiopathic, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Physiotherapy evaluation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Jul 2024
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with idiopathic scoliosis by a specialist physician at Gazi University Hospital, Deparment of Orthopedics and Traumatology will be included in the study.
Who may be able to join
- Diagnosis of idiopathic scoliosis by an orthopedist
- The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.
Who cannot join
- Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.
- History of previous spine or orthopedic surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital
Ankara, 06500
İnci H Ayas, 0 312 216 26 21, inciayass@gmail.com
About this study
Official title: Examining the Relationship Between Body Awareness and Spinal Stability in Individuals With Scoliosis
Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.
The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis.
Read the detailed description
The data obtained from the study will be analyzed using the Statistical Package for the Social Sciences (SPSS) software (IBM Corp., Armonk, NY, USA). Results will be presented as Mean ± Standard Deviation (X ± SD), percentage (%), or median with interquartile range (IQR), depending on their distribution normality. Data conforming to a normal distribution will be compared using the Independent Samples Student's t-test, while those not conforming will be analyzed using the Mann-Whitney U test. The relationship between variables will be assessed using the Spearman Correlation Test. A significance level of p < 0.05 will be utilized to determine statistical significance.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Physiotherapy evaluation
- Keywords
- Body Awareness, Spinal Stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy evaluationOther
In the physiotherapy evaluation, patients' spinal stability, rotary stability, and body awareness will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic scoliosis | The study group for this research comprises patients diagnosed with idiopathic scoliosis, a condition characterized by abnormal lateral curvature of the spine of unknown cause. Receives: Other: Physiotherapy evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal stability
Spinal stability will be assessed utilizing the Stabilizer Biofeedback Pressure device.Participants will lie on their backs on a Stabilizer Biofeedback Pressure unit connected to a manometer. The pressurized biofeedback device will be placed under the vertebrae and in the middle of the spina iliaca posterior superior (SIPS) by the physiotherapist. The valve of the manometer will be closed, and the cuff will be inflated to a pressure of 40 mm/Hg. Participants will then be instructed to perform the posterior pelvic tilt maneuver as demonstrated and maintain the position for 10 seconds. The value indicated on the manometer will be recorded. This measurement procedure will be repeated three times, and the average of these measurements will be utilized in the subsequent statistical analysis.
Measured: Initial examination
Rotary Stability
The Rotary Stability Test is a physical assessment used to evaluate an individual's ability to stabilize the spine and pelvis during rotational movements. During the test, the individual assumes a plank position (face down, supported by the toes and forearms) while maintaining a neutral spine alignment. Then, they are instructed to lift one arm and the opposite leg simultaneously while minimizing any rotation or movement in the torso and pelvis. The test measures the individual's ability to resist rotational forces.The patient will receive 3 points if the test is successfully repeated bilaterally, 2 points if it can be performed unilaterally, 1 point if there is a loss of balance during the test, and 0 points if the test cannot be completed.
Measured: Initial examination
Body Awareness
Body awareness will be evaluated using the Body Awareness Questionnaire comprising 18 items. Participants will be instructed to rate each question on a scale of 1 to 7.The total score to be taken from the survey can be 126 or at least 18.Higher total scores indicate greater levels of body awareness, while lower scores suggest lower levels of body awareness.
Measured: Initial examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (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.
- More trials run by Gazi 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Zeynep Hazar, Professor, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347419
- Sponsor's protocol ID
- Iayas8
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 4 Apr 2024
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Body Awareness and Spinal Stability in Individuals With Scoliosis
- ClinicalTrials.gov ID
- NCT06347419
- Acronym / sponsor ID
- Iayas8
- Conditions
- Scoliosis Idiopathic
- Keywords
- Body Awareness, Spinal Stability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 4 Apr 2024 (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.
Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.
The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis.
Detailed description
The data obtained from the study will be analyzed using the Statistical Package for the Social Sciences (SPSS) software (IBM Corp., Armonk, NY, USA). Results will be presented as Mean ± Standard Deviation (X ± SD), percentage (%), or median with interquartile range (IQR), depending on their distribution normality. Data conforming to a normal distribution will be compared using the Independent Samples Student's t-test, while those not conforming will be analyzed using the Mann-Whitney U test. The relationship between variables will be assessed using the Spearman Correlation Test. A significance level of p < 0.05 will be utilized to determine statistical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic scoliosis | – | Other: Physiotherapy evaluationThe study group for this research comprises patients diagnosed with idiopathic scoliosis, a condition characterized by abnormal lateral curvature of the spine of unknown cause. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with idiopathic scoliosis by a specialist physician at Gazi University Hospital, Deparment of Orthopedics and Traumatology will be included in the study.
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic scoliosis by an orthopedist
- The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.
Key exclusion criteria (2 listed)
- Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.
- History of previous spine or orthopedic surgery.
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 |
|---|---|---|
| Physiotherapy evaluationIn the physiotherapy evaluation, patients' spinal stability, rotary stability, and body awareness will be assessed. | Other | Idiopathic scoliosis |
Primary outcome
Spinal stability
Time frame: Initial examination
Spinal stability will be assessed utilizing the Stabilizer Biofeedback Pressure device.Participants will lie on their backs on a Stabilizer Biofeedback Pressure unit connected to a manometer. The pressurized biofeedback device will be placed under the vertebrae and in the middle of the spina iliaca posterior superior (SIPS) by the physiotherapist. The valve of the manometer will be closed, and the cuff will be inflated to a pressure of 40 mm/Hg. Participants will then be instructed to perform the posterior pelvic tilt maneuver as demonstrated and maintain the position for 10 seconds. The value indicated on the manometer will be recorded. This measurement procedure will be repeated three times, and the average of these measurements will be utilized in the subsequent statistical analysis.
Rotary Stability
Time frame: Initial examination
The Rotary Stability Test is a physical assessment used to evaluate an individual's ability to stabilize the spine and pelvis during rotational movements. During the test, the individual assumes a plank position (face down, supported by the toes and forearms) while maintaining a neutral spine alignment. Then, they are instructed to lift one arm and the opposite leg simultaneously while minimizing any rotation or movement in the torso and pelvis. The test measures the individual's ability to resist rotational forces.The patient will receive 3 points if the test is successfully repeated bilaterally, 2 points if it can be performed unilaterally, 1 point if there is a loss of balance during the test, and 0 points if the test cannot be completed.
Body Awareness
Time frame: Initial examination
Body awareness will be evaluated using the Body Awareness Questionnaire comprising 18 items. Participants will be instructed to rate each question on a scale of 1 to 7.The total score to be taken from the survey can be 126 or at least 18.Higher total scores indicate greater levels of body awareness, while lower scores suggest lower levels of body awareness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- 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.
Zeynep Hazar, Professor principal investigator
Gazi 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 Gazi University 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 2 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 4 Apr 2024. 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 İnci H Ayas, Msc (0 312 216 26 21, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal stability (time frame: Initial examination). 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?
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 4 Apr 2024.