Adolescent Idiopathic Scoliosis (AIS)ISAPISNCT06733623
Impact of Spinal Curves on Asymmetric Posture in Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis (AIS) and Juvenile Idiopathic Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Juvenile Idiopathic Scoliosis
- How many people
- 490 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2024to Jun 2026
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The participants of the study are patients of a tertiary referral outpatient clinic specializing in the conservative treatment of spinal deformity
Who may be able to join
- Diagnosis of juvenile or adolescent idiopathic scoliosis;
- Age between 6 and 18 years;
- Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.
- Age between 6 and 18 years;
- No diagnosis of sciolisis
- Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.
Who cannot join
- Diagnosis of secondary scoliosis
- Patients with neuromotor control disorders
- Control group:
- Patients with neuromotor control disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Presence and Type of Curves Influence the Choice of Asymmetric Postures Adopted in Daily Life by Patients with Juvenile and Adolescent Idiopathic Scoliosis?
Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis.
Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed.
Read more
Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition.
The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects.
Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures.
Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic 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 |
|---|---|---|
| Scoliosis patients | Patients aged between 6 and 18 years old with a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily | |
| Control group | Subjects aged between 6 and 18 years old without a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Everyday posture questionnaire
The types of postures most frequently maintained in daily life by patients with idiopathic scoliosis will be compared with a group of age-matched individuals without scoliosis, and any statistically significant differences will be analyzed using the chi-square test
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start10 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733623
- Sponsor's protocol ID
- 5461_20.11.2024_P_bis
- Acronym
- ISAPIS
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be uploaded on a public repository (Zenodo)
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Presence and Type of Curves Influence the Choice of Asymmetric Postures Adopted in Daily Life by Patients with Juvenile and Adolescent Idiopathic Scoliosis?
- ClinicalTrials.gov ID
- NCT06733623
- Acronym / sponsor ID
- ISAPIS / 5461_20.11.2024_P_bis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Dec 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.
Asymmetric postures are often observed in patients with adolescent idiopathic scoliosis (AIS) and are partially associated with instability in sitting and standing positions, as well as with imbalances in gait kinematic parameters in cases of moderate or severe scoliosis.
Based on the currently available data, no correlation has been identified between habitual postures in daily life and the presence of scoliosis. However, the asymmetry of preferred postures in relation to the morphological characteristics of the curves, and how this might contribute to the progression of the clinical condition due to prolonged uneven load distribution, has not yet been analyzed.
Understanding any preferential direction in postures habitually adopted by patients with idiopathic scoliosis could provide valuable insights for the conservative management of the condition.
The aim of this study is to analyze the influence of the morphological characteristics of scoliotic curves (type and laterality) in patients with juvenile and adolescent idiopathic scoliosis on the choice of preferentially maintained asymmetric postures in daily life, using a descriptive questionnaire completed by family members and caregivers, compared to a group of non-scoliotic subjects.
Evaluate the effect of curve magnitude, age, sex, and Risser grade on the choice of usual asymmetric postures.
Estimate the impact of prolonged maintenance of habitual asymmetric postures on the clinical progression in patients with juvenile and adolescent idiopathic scoliosis
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis patients | – | –Patients aged between 6 and 18 years old with a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily |
| Control group | – | –Subjects aged between 6 and 18 years old without a diagnosis of idiopathic scoliosis are asked to answer a questionnaire investigating the preferred postures adopted daily |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The participants of the study are patients of a tertiary referral outpatient clinic specializing in the conservative treatment of spinal deformity
Key inclusion criteria (6 listed)
- Diagnosis of juvenile or adolescent idiopathic scoliosis;
- Age between 6 and 18 years;
- Full spine X-ray in a standing position with anteroposterior projection performed within the year prior to completing the questionnaire.
- Age between 6 and 18 years;
- No diagnosis of sciolisis
Key exclusion criteria (4 listed)
- Diagnosis of secondary scoliosis
- Patients with neuromotor control disorders
- Patients with neuromotor control disorders
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
Everyday posture questionnaire
Time frame: At enrollment
The types of postures most frequently maintained in daily life by patients with idiopathic scoliosis will be compared with a group of age-matched individuals without scoliosis, and any statistically significant differences will be analyzed using the chi-square test
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 Dec 2024.
- Individual participant dataSharing planned: Yes. Anonymized data will be uploaded on a public repository (Zenodo)
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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?
An observational study of Adolescent Idiopathic Scoliosis (AIS) and Juvenile Idiopathic Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
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 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 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 Italy. 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?
Everyday posture questionnaire (time frame: At enrollment). 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 Dec 2024.