Prospective Longitudinal Monocentric Study to Evaluate the Feasibility of Syde® Digital Endpoints for Monitoring Patients With Progressive Supranuclear Palsy - Richardson Syndrome (PSP-R)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- SYSNAV
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Number of patients reaching the optimal threshold of recordings during the recording periods defined in the protocol.
时间窗: 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.
French Usability score (F-SUS) at Month 4 and at the end of the study
时间窗: 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).
次要结局
- Change from baseline in the total wearing time at months 4, 8, 12, and 16.(16 months)
- Reproducibility of Syde® digital endpoints for each recording period timepoint(16 months)
- Correlation between Syde® digital endpoints and 2-minute walk test (2MWT)(16 months)
- Correlation between Syde® digital endpoints and 10-meter walk test (10MWT)(16 months)
- Correlation between Syde® digital endpoints and Timed Up and Go (TUG)(16 months)
- Correlation 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)(16 months)
- Correlation between Syde® digital endpoints and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)(16 months)
- Correlation between Syde® digital endpoints and Montreal Cognitive Assessment (MoCA)(16 months)
- Longitudinal change in Syde® digital endpoints. The Syde® digital endpoints will include the SV95C (Stride Velocity 95th centile)(16 months)