Actively Recruiting
Prospective Longitudinal Monocentric Study to Measure Limb Movement in Patients With FGFR3-related Skeletal Dysplasia Using Syde ae
Led by SYSNAV · Updated on 2026-02-20
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating which digital outcomes derived from the Syde ae device are reliable for patients with FGFR3-related Skeletal Dysplasia, specifically those with Achondroplasia (ACH) or Hypochondroplasia (HCH). This natural history study aims to measure limb movements over time to better understand mobility in these conditions. The research is sponsored by SYSNAV and involves participants aged 3 to 65 years. Participants will use the Syde ae device to record limb movements during scheduled 4-week recording periods every 6 months over a total duration of 12 months. The study includes assessments such as the 6-minute walk test and growth measurements, alongside patient-reported outcomes and qualitative interviews to explore mobility limitations. Device accuracy will be compared to Optical Motion Capture at baseline. Throughout the study, participants will complete questionnaires and comply with device-related procedures including multiple recording periods. Researchers will monitor the reliability of digital endpoints, usability of the device, and correlations with clinical and patient-reported measures. Safety and adherence will be tracked, and the primary outcome is the reliability of digital endpoints assessed at 12 months.
CONDITIONS
Brief Title
Prospective Longitudinal Monocentric Study to Measure Limb Movement in Patients With FGFR3-related Skeletal Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 3 years old or older at the time of consent
- Written informed consent obtained from parent(s) or legal guardian(s) for participants under 18 years old, or from participants 18 years old and older
- Affiliated to, or beneficiary of a social security category
- Able to walk unassisted for at least 10 meters
- Genetically confirmed diagnosis with one pathogenic variant (ACMG class IV & V) of achondroplasia or hypochondroplasia
- Participant and caregivers (if under 18) willing and able to comply with all study procedures including questionnaires and Syde�ae related procedures
You will not qualify if you...
- Short stature condition other than achondroplasia or hypochondroplasia
- Cognitive disorders limiting understanding of study procedures and consent
- Concurrent disease or condition affecting growth, motor, balance, or gait function (neurological, endocrine, infectious, allergic, osteoarthritis, inflammatory)
- Females who are pregnant or planning to become pregnant during the study
- Body Mass Index of 35 kg/m2 or higher
- Recent upper or lower limb injury or surgery within 6 months before inclusion
- Prior limb lengthening surgery or planned limb lengthening during the study
- Presence of guided growth hardware or planned orthopedic surgeries during the study
- Vulnerable patients unable to provide or express informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants are observed using the Syde® device to measure limb movement and complete questionnaires and interviews about mobility and daily life impact.
Periodic assessments including baseline and follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Hopital Necker
Paris, France, 75015
Actively Recruiting
Research Team
F
Ferial Toumi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here