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.
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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 With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
Cohort
Prospective
Not listed
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
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
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).
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Reproducibility of Syde® digital endpoints for each recording period timepoint
Reproducibility of Syde® digital endpoints assessed by the ICC (Intra-Class Correlation) and Bland and Altman analysis for each recording period timepoint (baseline, 4 months, 8 months, 12 months, and 16 months)
Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)
Correlation at baseline and at different timepoints between Syde® digital endpoints and 2MWT
Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)
Correlation at baseline and at different timepoints between Syde® digital endpoints and 10MWT
This trial is not recruiting at the moment. You can still explore other options:
