AzTrials
AzTrials

Healthy VolunteersIMoFARPNCT07251634

Construction of a Reference Corridor to Assess the Value of Combining Innovative Morphological and Functional Analysis Techniques in Pediatric Patient Care Based on Different Pathological Models

A study testing Markerless gait analysis in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Markerless gait analysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteFrance
Study dates
1 Dec 2025to 1 Dec 2028
Phase
Interventional
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

Who may be able to join

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

Who cannot join

  • No exclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anne-Laure SIMON, MD contact

+331.40.03.20.00

anne-laure.simon@aphp.fr

Virginie NGUYEN KHAC, MD contact

+331.40.03.20.00

virginie.nguyenkhac@aphp.fr

France1 site
  • Robert Debre Hospital

    Paris, 75019

    Anne-Laure SIMON, MD, +331.40.03.20.00, anne-laure.simon@aphp.fr

    Virginie NGUYEN KHAC, MD, +331.40.03.20.00, virginie.nguyenkhac@aphp.fr

Other trials in France

About this study

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.

Read the detailed description

Deformities of the lower limbs (LL) and spine have a severe functional impact on quality of life, whether they are present at birth (malformation) or develop with the acquisition of walking (deformity). These abnormalities result from de novo or hereditary genetic mutations, and their cause often remains unknown. These deformities do not only affect the skeletal system. They are abnormalities of the entire musculoskeletal system, associated with muscle damage and changes in the ligament and capsular systems. All of these conditions result in functional walking disorders that impair patients' quality of life.

The development of innovative techniques in recent years has enabled accurate and safe morphological (EOS stereoradiography and muscle MRI in different sequences) and functional (quantified gait analysis, QGA) analyses, allowing for better diagnostic and therapeutic management of pediatric patients. Radiological examinations (EOS, MRI) are readily available in routine clinical practice. Gait analysis still requires a specialized laboratory and a dedicated team to place markers and analyze data, which limits its use despite its proven usefulness in various pathologies. However, it is an indispensable tool as it provides an objective, quantified measurement of gait function. It has long been demonstrated that this tool is invaluable in aiding diagnosis, therapeutic decisions, and monitoring the effectiveness of treatments undertaken.

In recent years, new markerless motion capture systems have been developed with the aim of simplifying access to this tool in clinical practice. One such motion capture system was developed by teams of engineers at the ENSAM biomechanics laboratory and was tested and validated on a population of 31 volunteers. This system obtained positive results in terms of gait joint position error when compared to standard three-dimensional AQM. With regard to gait parameters, it has been validated as sufficiently accurate for measuring the spatiotemporal parameters of gait in clinical applications, but still requires adjustments to the kinematic parameters of gait for clinical application. Quantified gait analysis (QGA) enables three-dimensional analysis of movement using motion capture systems (kinematic analysis) and ground reaction force analysis (kinetic analysis). These systems consist of infrared cameras that capture retro-reflective markers positioned on anatomical landmarks of the human body for kinematic analysis. For kinetic analysis, the forces exerted (vectors, moments, and powers) on the joints of the trunk, hip, knee, and ankle are measured using force platforms. This 3D joint movement data aids in the functional diagnosis of patients with many different pathologies and enables a selective therapeutic approach. This "classic" three-dimensional AQM is performed in dedicated, secure laboratories, requiring the presence of an engineer and a medical team to acquire, process, and interpret the data from these analyses, which limits its use due to the time required to interpret the data. Markerless motion capture systems with fewer cameras have been developed in recent years. Such a system has been developed at ENSAM's LBM and is based on "human pose estimation," a computer vision method. Using four RGB (red, green, blue) cameras to calculate walking parameters and artificial intelligence techniques, this system determines the position of the joint centers. It has been tested and validated on a sample of 31 subjects (adults and children) at the Georges Charpak Institute of Human Biomechanics. This system has been validated for the use of spatiotemporal parameters in clinical applications but still requires adjustments to the kinematic parameters. The validation of this markerless AQM for various pathologies, such as hereditary and/or congenital abnormalities of the lower limbs and/or spine, followed by its implementation in routine clinical practice, would represent a major advance in the understanding of different musculoskeletal models and in the diagnostic, therapeutic, and follow-up management of these pathologies.

The existence of pediatric reference corridors is uncommon, mainly due to the changes that occur throughout growth. A comparison between a sick child and a healthy adult is therefore not possible, due to the specific properties of growth. Furthermore, within pediatrics itself, a child who is still learning to walk cannot be compared to an athletic teenager. Obtaining reference standards for this markerless motion capture system based on healthy children would allow for subsequent comparison with any pathology of the lower limbs and/or spine of children undergoing this examination in routine clinical practice.

Being tested
Markerless gait analysis
Keywords
Markerless, reference corridor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Markerless gait analysisDevice

    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.

Study groups in NCT07251634
Study groupRoleWhat they receive
healthy children without spinal and/or lower limb pathologiesExperimentalhealthy children without spinal and/or lower limb pathologies recruited from orthopedic consultations, siblings of patients, children of staff, and word of mouth.
Receives: Device: Markerless gait analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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."
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07251634
Sponsor's protocol ID
APHP250630
Other IDs
IDRCB: 2025-A00364-45
Acronym
IMoFARP
Status last verified
Sep 2025
First submitted
29 Sep 2025
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Markerless gait analysis in people with Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 1 inclusion and 1 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 26 Nov 2025. 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 France. 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?

Contact Anne-Laure SIMON, MD (+331.40.03.20.00, anne-laure.simon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of kinematic parameters of the trunk, the hip, the knee, the ankle during gait. (time frame: 36 months). 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 26 Nov 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in