Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progres… (NCT07389018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
France30 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓.18 years old or older
✓.Participants affiliated to, or beneficiary from, a social security.
✓.Ambulant patients (i.e. able to walk 10 meters without assistance)
✓.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..
✓.Possible or probable PSP-R according to MDS criteria 2017(Hoglinger et al., Mov Disorder, 2017).
Exclusion criteria
✕. 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.
✕. Patients who do not tolerate to keep the sensors on their ankles.
✕. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the lower limbs.
✕. A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.
✕. Patients affected by any other disorder having a significant impact on gait or lower limb function.
✕
What they're measuring
1
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
Timeframe: 16 months
2
French Usability score (F-SUS) at Month 4 and at the end of the study