Hôpital Fondation Adolphe de Rothschild
Paris, 75019, France
NCT Number: NCT07389018
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Paris, 75019, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: 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.
Time frame: 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).
Time frame: 16 months
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Time frame: 16 months
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)
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and 2MWT
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and 10MWT
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and TUG
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and falls reported by the participants
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-RS
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-CDS
Time frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and MoCA
Time frame: 16 months
Change from baseline in Syde® digital endpoints at 4, 8, 12 and 16 months. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)
Contact information is provided by the study sponsor or research team.
SYSNAV
Industry
Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
Acronym: PROSPER-SYDE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.