NCT07581015

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jul 2028

First Submitted

Initial submission to the registry

May 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • A classification model based on ML using plantar pressure data to distinguish between scoliosis patients and healthy volunteers.

    6 months after data collection

Study Arms (2)

scoliosis patients

healthy volunteers

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE