Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Progressive Supranuclear Palsy- Richardson Syndrome (PSP-R). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
Overview
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.
Primary outcome measures
- Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol. [Time frame: 16 months]
- French Usability score (F-SUS) at Month 4 and at the end of the study [Time frame: 16 months]
Secondary outcome measures (10)
- 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 [Time frame: 16 months]
- Correlation between Syde® digital endpoints and 2-minute walk test (2MWT) [Time frame: 16 months]
- Correlation between Syde® digital endpoints and 10-meter walk test (10MWT) [Time frame: 16 months]
- Correlation between Syde® digital endpoints and Timed Up and Go (TUG) [Time frame: 16 months]
- Correlation 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) [Time frame: 16 months]
- Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS) [Time frame: 16 months]
- Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA) [Time frame: 16 months]
- Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile) [Time frame: 16 months]
Eligibility criteria
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
- 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.
- Participant covered by a legal protection measure (guardianship, curatorship or safeguarding of justice) or who is unable to express their consent.
- Absence of caregiver.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Fondation Adolphe de Rothschild — Paris
Identifiers
NCT: NCT07389018 · PR5030-76 · 2024-A02611-46