Scoliosis IdiopathicNCT04677140
Hip Related Functional Limitations in Individuals With Idiopathic Scoliosis
An observational study of Scoliosis Idiopathic, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the functional parameters of hip and jaw in terms of scoliosis degree and scoliosis pattern in individuals with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 1 Nov 2021
- How long will I take part?
- 1 Year
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Our study will include cases who applied to Hacettepe University, Faculty of Physical Medicine and Rehabilitation with a diagnosis of scoliosis, had anterior-posterior and lateral radiographs, accepted to participate in the study on a voluntary basis, were literate and cooperated in completing the scales. In cases under the age of 18, the evaluation will be started by obtaining additional family consent.
Who may be able to join
- Having been diagnosed with adolescent idiopathic scoliosis by a specialist physician with existing anterior-posterior and lateral lateral radiographs,
- Primary curvature over 10 degrees in the coronal plane according to the Cobb method,
- Being literate,
- To cooperate in answering and implementing evaluation scales,
- Children with written consent from their parents and themselves will be included.
Who cannot join
- Having any systemic illness,
- Spinal surgery history,
- Presence of any acute or chronic disease other than scoliosis,
- Inadequate quality to examine the measurement parameters of the current vertebral radiography,
- Use of musical instruments,
- Long-term and professional sports.
Show all 14Show fewer
- Having any systemic illness,
- Spinal surgery history,
- Presence of any acute or chronic disease other than scoliosis,
- Aesthetics or any injection intervention in the face and neck area,
- Spinal surgery history,
- Orthodontic treatment,
- Use of musical instruments,
- Long-term and professional sports.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Physical Therapy and Rehabilitation Faculty
Ankara
About this study
The aim of this study is to examine the functional parameters of hip and jaw in terms of scoliosis degree and scoliosis pattern in individuals with idiopathic scoliosis.
Read the detailed description
In this study investigators will examine the hip functional parameters and jaw functional parameters separately.
In hip study hip functional parameters will be evaluated for determining the correlation between scoliosis degree/pattern and hip functions.
In jaw study jaw functional parameters will be evaluated for determining the correlation between scoliosis degree/pattern and hip functions.
- Conditions
- Scoliosis Idiopathic
- Keywords
- scoliosis, hip, jaw, adolescent idiopathic scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | By a specialist physician with existing anteroposterior and lateral radiographs have been diagnosed with adolescent idiopathic scoliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
single leg squat test (SLS)
single leg squat test will be evaluated for each patient (min:0, max:3)
Measured: Baseline
Secondary outcomes (1)
Y balance test (YBT)
Y balance test will be evaluated (cm)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Nov 2020
- Primary completion15 Sep 2021
- Study completion1 Nov 2021
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 Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Çelik, Hacettepe University
- Investigators
- Gözde Yağcı, Study director, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677140
- Sponsor's protocol ID
- GO 20/694
- Status last verified
- Mar 2022
- First submitted
- 3 Dec 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Choudhry MN, Ahmad Z, Verma R. Adolescent Idiopathic Scoliosis. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. eCollection 2016.
PubMed 27347243
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip Related Functional Limitations in Individuals With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04677140
- Acronym / sponsor ID
- GO 20/694
- Conditions
- Scoliosis Idiopathic
- Keywords
- scoliosis, hip, jaw, adolescent idiopathic scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 21 Dec 2020 (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 examine the functional parameters of hip and jaw in terms of scoliosis degree and scoliosis pattern in individuals with idiopathic scoliosis.
Detailed description
In this study investigators will examine the hip functional parameters and jaw functional parameters separately.
In hip study hip functional parameters will be evaluated for determining the correlation between scoliosis degree/pattern and hip functions.
In jaw study jaw functional parameters will be evaluated for determining the correlation between scoliosis degree/pattern and hip functions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experiment group | – | –By a specialist physician with existing anteroposterior and lateral radiographs have been diagnosed with adolescent idiopathic scoliosis |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Our study will include cases who applied to Hacettepe University, Faculty of Physical Medicine and Rehabilitation with a diagnosis of scoliosis, had anterior-posterior and lateral radiographs, accepted to participate in the study on a voluntary basis, were literate and cooperated in completing the scales. In cases under the age of 18, the evaluation will be started by obtaining additional family consent.
Key inclusion criteria (5 listed)
- Having been diagnosed with adolescent idiopathic scoliosis by a specialist physician with existing anterior-posterior and lateral lateral radiographs,
- Primary curvature over 10 degrees in the coronal plane according to the Cobb method,
- Being literate,
- To cooperate in answering and implementing evaluation scales,
- Children with written consent from their parents and themselves will be included.
Key exclusion criteria (14 listed)
- Having any systemic illness,
- Spinal surgery history,
- Presence of any acute or chronic disease other than scoliosis,
- Inadequate quality to examine the measurement parameters of the current vertebral radiography,
- Use of musical instruments,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
single leg squat test (SLS)
Time frame: Baseline
single leg squat test will be evaluated for each patient (min:0, max:3)
1 secondary outcome
Y balance test (YBT)
Time frame: Baseline
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 16 Mar 2022.
- Background: PubMed 27347243Choudhry MN, Ahmad Z, Verma R. Adolescent Idiopathic Scoliosis. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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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.
Gözde Yağcı study director
associate professor
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 Hacettepe 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 5 inclusion and 14 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 16 Mar 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?
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?
single leg squat test (SLS) (time frame: Baseline). 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 NCT04677140, 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 16 Mar 2022.