Clinical Trials in France / NCT07389018
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Observational
Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
NCT07389018 · tracked via the Priya Life Science France tracker
Condition(s) studied
Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R)
Study summary
The study aims to assess the feasibility/acceptability of real-world activity monitoring by the Syde® wearable device in PSP-R. The Syde® collected data will be compared to on-site conventional clinical endpoints, including functional capacity and cognitive assessments, as well as core scales assessments.
Eligibility
Inclusion Criteria:
1.18 years old or older
2.Participants affiliated to, or beneficiary from, a social security.
3.Ambulant patients (i.e. able to walk 10 meters without assistance)
4.Signed informed consent form by the patient himself or, by caregivers if the patient is not capable to fill, date and sign the form due to fine motor function difficulties..
5.Possible or probable PSP-R according to MDS criteria 2017(Hoglinger et al., Mov Disorder, 2017).
Exclusion Criteria:
1. Patients with extreme cognitive disorders that limit their understanding of the data collection process (training of device use and 4-week recording periods every 4 months, device return at the end of the study), tests to be performed including eye movement recording (every 8 months), the implication of the study and consent.
2. Patients who do not tolerate to keep the sensors on their ankles.
3. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the lower limbs.
4. A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.
5. Patients affected by any other disorder having a significant impact on gait or lower limb function.
6. Participant covered by a legal protection measure (guardianship, curatorship or safeguarding of justice) or who is unable to express their consent.
7. Absence of caregiver.
Primary outcome measure(s)
- Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol. — 16 months
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol (supposed optimal threshold for analysis) at baseline, Month 4, Month 8, Month 12 and Month 16. - French Usability score (F-SUS) at Month 4 and at the end of the study — 16 months
Usability score at Month 4 and Month 16. The System Usability Scale is a 10-item questionnaire . It is a simple tool to measure the usability of an interactive system and it is widely used. For each item, the user is asked to express their level of agreement or disagreement from 1 (strongly disagree) and 5 (strongly agree).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital Fondation Adolphe de Rothschild | Paris | France |
More SYSNAV trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07389018 on ClinicalTrials.gov ↗ ← All trials in France