Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R) (PROSPER-SYDE)

April 21, 2026 updated by: SYSNAV

Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)

Description

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:

  1. 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.
  2. Patients who do not tolerate to keep the sensors on their ankles.
  3. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the lower limbs.
  4. A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.
  5. Patients affected by any other disorder having a significant impact on gait or lower limb function.
  6. Participant covered by a legal protection measure (guardianship, curatorship or safeguarding of justice) or who is unable to express their consent.
  7. Absence of caregiver.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
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.
16 months
French Usability score (F-SUS) at Month 4 and at the end of the study
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).
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
Time Frame: 16 months
Change from baseline in the total wearing time at months 4, 8, 12, and 16.
16 months
Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)
Time Frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and 2MWT
16 months
Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)
Time Frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and 10MWT
16 months
Correlation between Syde® digital endpoints and Timed Up and Go (TUG)
Time Frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and TUG
16 months
Correlation 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 falls reported by the participants
16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Rating Scale (PSP-RS)
Time Frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-RS
16 months
Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)
Time Frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and PSP-CDS
16 months
Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA)
Time Frame: 16 months
Correlation at baseline and at different timepoints between Syde® digital endpoints and MoCA
16 months
Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)
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)
16 months
Reproducibility of Syde® digital endpoints for each recording period timepoint
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)
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SYSNAV

Investigators

  • Principal Investigator: Jean-Philippe BRANDEL, Hôpital Fondation Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PR5030-76
  • 2024-A02611-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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