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SKY-MOT3Syde®-derived Digital Outcomes for Limb Movement in FGFR3-related Skeletal Dysplasia

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Study Aim

This observational study aims to assess the reliability of digital endpoints derived from Syde®, measured by the Intra-Class Correlation (ICC), for each recording period timepoint in individuals with FGFR3-related Skeletal Dysplasia.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Achondroplasia+5

+ Bone Diseases

+ Bone Diseases, Developmental

From 3 to 65 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2026
See protocol details

Summary

Principal SponsorSYSNAV
Study ContactFerial Toumi
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding the movement of limbs in patients with FGFR3-related Skeletal Dysplasia, specifically those with ACH or HCH. The goal is to identify which digital outcomes derived from a tool called Syde® are reliable for these patients. The importance of this study lies in establishing a natural history of the condition, which could potentially improve the understanding and management of FGFR3-related Skeletal Dysplasia. During the study, participants' limb movements will be measured using Syde® at different time points: when they first join the study, after 6 months, and after 12 months. The reliability of these measurements will be assessed using a statistical method called the Intra-Class Correlation (ICC). This will help determine how consistent the Syde® measurements are over time, providing valuable insights into the progression of the condition.

Official TitleProspective Longitudinal Monocentric Study to Measure Limb Movement in Patients With FGFR3-related Skeletal Dysplasia Using Syde®
NCT07388966
Principal SponsorSYSNAV
Study ContactFerial Toumi
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AchondroplasiaBone DiseasesBone Diseases, DevelopmentalDwarfismMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOsteochondrodysplasiasGenetic Diseases, Inborn

Criteria

6 inclusion criteria required to participate
Written informed consent obtained: From the parent(s) or legal guardian(s) for participants under 18 years old and from participants 18 years old and older.
Participant (and caregivers for participants under 18 years old) willing and able to comply with all study procedures including: questionnaires, Syde® related procedures.
Aged 3 years old or older at the time of consent.
Able to walk unassisted for at least 10 meters.
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9 exclusion criteria prevent from participating
Presence of cognitive disorders that limit their understanding of the data collection process, the implication of the study and consent.
Presence or history of any concurrent disease or condition that could interfere with study participation, impact pediatric growth, affect motor or balance or gait function (such as neurological, endocrine, infectious, allergic, osteoarthritis, or inflammatory), assessed by the investigator.
Females who are pregnant, or planning to become pregnant during the study duration.
Body Mass Index = 35 kg/m2.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hopital Necker

Paris, FranceOpen Hopital Necker in Google Maps
Recruiting soonOne Study Center