Adolescent Idiopathic Scoliosis (AIS)NCT07581015
Detection of Scoliosis
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by University College, London.
Trial summary
This study aims to evaluate whether plantar pressure data collected during standing and walking can be used with machine learning to support early detection of scoliosis in young people. Patients with scoliosis and healthy volunteers aged 10-18 will undergo a short assessment using a pressure mat. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jul 2028
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young people aged 10-18 years will be recruited from scoliosis clinics at the Royal National Orthopaedic Hospital (patients with a confirmed diagnosis of scoliosis) and through community recruitment for healthy volunteers. Eligible participants must be able to stand and/or walk on a pressure mat.
Who may be able to join
- Healthy Controls: Adolescents without any spinal condition or significant musculoskeletal issues, and with no prior history of scoliosis, to provide normal plantar pressure data for comparison.
- Scoliosis Diagnosis: Adolescents diagnosed with adolescent idiopathic scoliosis (AIS) by a healthcare professional (through clinical evaluation and/or radiographic assessment) are eligible.
- Age: Participants must be between the ages of 10 and 18 years at the time of recruitment.
- Willingness to Participate: Participants and their parent(s)/guardian(s) must provide informed consent/assent prior to participation.
- Ability to Complete Study Procedures: Participants must be able to complete the plantar pressure measurement test, which requires standing on a pressure mat for a few minutes.
Who cannot join
- Severe Pain or Discomfort: Participants unable to stand or walk comfortably due to pain or musculoskeletal issues.
- Non-cooperation: Participants who are unable or unwilling to follow instructions or consent/assent procedures.
- Uncontrolled Medical Conditions: Adolescents with uncontrolled conditions (e.g., cardiovascular or endocrine disorders) compromising participation.
- Recent Foot Injuries or Conditions: Participants with foot injuries or conditions (e.g., wounds, infections) that may interfere with plantar pressure measurement.
About this study
Official title: Early Detection of Adolescent Idiopathic Scoliosis Using Machine Learning on Plantar Pressure Data
This study aims to evaluate whether plantar pressure data collected during standing and walking can be used with machine learning to support early detection of scoliosis in young people. Patients with scoliosis and healthy volunteers aged 10-18 will undergo a short assessment using a pressure mat.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
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 | Not described | |
| healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A classification model based on ML using plantar pressure data to distinguish between scoliosis patients and healthy volunteers.
Measured: 6 months after data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (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.
- More trials run by University College, LondonThe 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581015
- Sponsor's protocol ID
- IRAS: 357368
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Adolescent Idiopathic Scoliosis Using Machine Learning on Plantar Pressure Data
- ClinicalTrials.gov ID
- NCT07581015
- Acronym / sponsor ID
- IRAS: 357368
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 May 2026 (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 aims to evaluate whether plantar pressure data collected during standing and walking can be used with machine learning to support early detection of scoliosis in young people. Patients with scoliosis and healthy volunteers aged 10-18 will undergo a short assessment using a pressure mat.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scoliosis patients | – | – |
| healthy volunteers | – | – |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young people aged 10-18 years will be recruited from scoliosis clinics at the Royal National Orthopaedic Hospital (patients with a confirmed diagnosis of scoliosis) and through community recruitment for healthy volunteers. Eligible participants must be able to stand and/or walk on a pressure mat.
Key inclusion criteria (5 listed)
- Healthy Controls: Adolescents without any spinal condition or significant musculoskeletal issues, and with no prior history of scoliosis, to provide normal plantar pressure data for comparison.
- Scoliosis Diagnosis: Adolescents diagnosed with adolescent idiopathic scoliosis (AIS) by a healthcare professional (through clinical evaluation and/or radiographic assessment) are eligible.
- Age: Participants must be between the ages of 10 and 18 years at the time of recruitment.
- Willingness to Participate: Participants and their parent(s)/guardian(s) must provide informed consent/assent prior to participation.
- Ability to Complete Study Procedures: Participants must be able to complete the plantar pressure measurement test, which requires standing on a pressure mat for a few minutes.
Key exclusion criteria (4 listed)
- Severe Pain or Discomfort: Participants unable to stand or walk comfortably due to pain or musculoskeletal issues.
- Non-cooperation: Participants who are unable or unwilling to follow instructions or consent/assent procedures.
- Uncontrolled Medical Conditions: Adolescents with uncontrolled conditions (e.g., cardiovascular or endocrine disorders) compromising participation.
- Recent Foot Injuries or Conditions: Participants with foot injuries or conditions (e.g., wounds, infections) that may interfere with plantar pressure measurement.
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
A classification model based on ML using plantar pressure data to distinguish between scoliosis patients and healthy volunteers.
Time frame: 6 months after data collection
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 12 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by University College, London.
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 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: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
A classification model based on ML using plantar pressure data to distinguish between scoliosis patients and healthy volunteers. (time frame: 6 months after data collection). 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 12 May 2026.