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.
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.
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
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.
- Conditions
- Healthy Volunteers
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Markerless gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted26 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure SIMON, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07251634
- Acronym / sponsor ID
- IMoFARP / APHP250630
- Conditions
- Healthy Volunteers
- Keywords
- Markerless, reference corridor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Nov 2025 (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.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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."
| Arm | Type | Receives |
|---|---|---|
| healthy children without spinal and/or lower limb pathologies | Experimental | Device: Markerless gait analysishealthy children without spinal and/or lower limb pathologies recruited from orthopedic consultations, siblings of patients, children of staff, and word of mouth. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy volunteer, >6 years old and <18 years old, male or female, Affiliated under the parental social security scheme
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Markerless gait analysisInclusion 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. | Device | healthy children without spinal and/or lower limb pathologies |
Primary outcome
Analysis of kinematic parameters of the trunk, the hip, the knee, the ankle during gait.
Time frame: 36 months
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.
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
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.
Anne-Laure SIMON, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.