Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-24 @ 3:35 PM
NCT ID:
NCT05597592
Eligibility Criteria:
Inclusion Criteria:
* Age higher than 18 years old
* Patient living in the cross-border region concerned by the PROSOL project (Provence Alpes Cote d'Azur, Liguria, Piedmont and Aosta valley)
* Patient with neuropathy with genetic confirmation or myopathy with genetic confirmation or a minor neurocognitive disorder (DSM V criteria) with a Mini Mental State Examination (MMSE) score greater tha or equal to 15 and less than 26
* Patient able to perform the self-rehabilitation program alone or with the help of a caregiver (at the investigator's discretion): ambulant patients alone or with assistance (group 1) or non-ambulant patients able to transfer independently (group 2)
* Likely to be followed by telemedicine (equipped with a smartphone (Apple or Android) and/or a computer, a camera, an internet connection, the smartphone should be compatible with the use of the connected watch (possibility to download mobile applications: Healthmate, Link4life and Telegram
* Patient not planning any change in his lifestyle in the month following the inclusion (hiking, joining a gym, total immobility...)
* Patient able to comply with the instructions and procedures specified in the clinical protocol
* Patient has given free and informed consent
* Patient affiliated to a social security system.
Exclusion Criteria:
* Patient with balance disorders that are incompatible with the proper conduct of the study based on the investigator's judgment at the inclusion visit
* Patient with any pathologies or comorbidities incompatible with the proper conduct of the study according to the investigator's judgement during the inclusion visit (heart problems, respiratory problems, etc…)
* Patient with pacemaker (this could interfere with data collected by the smartwatch)
* Patient with respiratory problems requiring non-invasive ventilation (NIV) or oxygen therapy
* Patient presenting or having presented in the previous month the inclusion of average physical tiredness (EVA tiredness \> 6)
* Patient presenting or having presented in the month before the inclusion of myalgia (EVA pain \> 6)
* Pregnant or lactating woman or woman of childbearing age without contraception
* Patient protected by law under guardianship or curatorship, or not able to participate in a clinical study under article L. 1121-16 of the French Public Health Code
* Patient refusing to participate in the study or expressing opposition to participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05597592
Study Brief:
Protocol Section:
NCT05597592