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.
Study Type
OBSERVATIONAL
Enrollment
30
Hôpital Fondation Adolphe de Rothschild
Paris, France
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.
Time frame: 16 months
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).
Time frame: 16 months
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.
Time frame: 16 months
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)
Time frame: 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
Time frame: 16 months
Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)
Correlation at baseline and at different timepoints between Syde® digital endpoints and 10MWT
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Time frame: 16 months
Correlation between Syde® digital endpoints and Timed Up and Go (TUG)
Correlation at baseline and at different timepoints between Syde® digital endpoints and TUG
Time frame: 16 months
Correlation between Syde® digital endpoints and falls reported by the participants
Correlation at baseline and at different timepoints between Syde® digital endpoints and falls reported by the participants
Time frame: 16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Rating Scale (PSP-RS)
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-RS
Time frame: 16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-CDS
Time frame: 16 months
Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA)
Correlation at baseline and at different timepoints between Syde® digital endpoints and MoCA
Time frame: 16 months
Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)
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)
Time frame: 16 months