NCT07251634

Brief Summary

Reference motion analysis systems require a dedicated, specific laboratory environment, with self-reflective markers placed on anatomical points by trained personnel, limiting gait analysis to specific pathologies. Some markerless systems have emerged but still require numerous cameras and are expensive. The implementation of a markerless motion capture system based on only four cameras in routine clinical practice would broaden the indications for gait analysis to include any pathology of the lower limbs and/or spine in the pediatric population.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
31mo left

Started Dec 2025

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

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 Progress16%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 26, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 29, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

Markerlessreference corridor

Outcome Measures

Primary Outcomes (1)

  • Analysis of kinematic parameters of the trunk, the hip, the knee, the ankle during gait.

    RANGE OF MOTION in DEGREE for the flexion/extension - abduction/adduction - internal/external rotation of the trunk, hip, knee, ankle in degrees, obtained by Matlab.

    36 months

Study Arms (1)

healthy children without spinal and/or lower limb pathologies

EXPERIMENTAL

healthy children without spinal and/or lower limb pathologies recruited from orthopedic consultations, siblings of patients, children of staff, and word of mouth.

Device: Markerless gait analysis

Interventions

Inclusion of healthy children without spinal and/or lower limb pathologies recruited from orthopedic consultations, siblings of patients, children of staff, and word of mouth. Markerless AQM performed on the same day. Data collected by a single person using an EpiData-type data entry form. Blurred videos processed and archived at Arts et Métiers for 15 years on a secure server.

healthy children without spinal and/or lower limb pathologies

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy volunteer, \>6 years old and \<18 years old, male or female, Affiliated under the parental social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Study Officials

  • Anne-Laure SIMON, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure SIMON, MD

CONTACT

Virginie NGUYEN KHAC, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Inclusion of healthy children without spinal and/or lower limb pathologies recruited from orthopedic consultations, siblings of patients, children of staff, and word of mouth. Markerless AQM performed on the same day. Data collected by a single person using an EpiData-type data entry form. Blurred videos processed and archived at Arts et Métiers for 15 years on a secure server."
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2025

First Posted

November 26, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 26, 2025

Record last verified: 2025-09

Locations