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:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT04543058
Eligibility Criteria:
Inclusion Criteria:
Specific Inclusion Criteria:
* Have a diagnosis of idiopathic PD according to the MDS clinical Diagnostic Criteria for PD (Postuma et al. 2015);
* Have a walking disorder defined by the neurologist (Item 10 of the MDSUPDRS-III ≥1);
* Be able to walk 30 consecutive minutes without technical assistance (e.g. cane or walker) or human assistance;
* Receive an uninterrupted antiparkinsonian pharmacological treatment since one month (and throughout the study period).
Non-Specific Inclusion Criteria:
* Be over 35 and under 95 of age;
* Be able to understand the nature, purpose and methodology of the study and agree to cooperate during assessments;
* Have signed the informed consent;
* Be affiliated to a social security plan or affiliated to such a equivalent health plan.
Non-Inclusions:
Specific Non-Inclusion Criteria:
* Presence of signs in favor of an atypical parkinsonian syndrome (involvement oculomotor, early falls, hallucinations, Montreal Cognitive Assessment \<21/30, severe and early dysautonomia);
* Have a hearing impairment;
* Have any other neurological damage that affects walking;
* Have a walking disorder of other origin (e.g. orthopedic, rheumatological, etc.);
* Have severe or unbalanced heart or respiratory Failure which contraindicates walk rehabilitation.
Non-Specific Non-Inclusion Criteria:
* Adult under legal protection or unfit to express their consent (Article 1121-8 of the CSP);
* Vulnerable people (Article L 1121-6 of the CSP);
* Loss of liberty by judicial or administrative decision;
* High probability of non-compliance with the protocol or abandonment during the study;
* Pregnant / lactating women.
Non-Inclusion Criteria for the subgroup that will carry out the MRI ancillary study:
* Pacemaker or neurosensory stimulator or implantable defibrillator;
* Cochlear implants;
* Foreign ferromagnetic ocular or cerebral bodies close to nervous structures
* Metal prosthesis;
* Agitation of the participants: non-cooperative or agitated participants;
* Claustrophobic participants;
* Pregnant woman;
* Ventriculo-peritoneal neurosurgical bypass valves;
* Braces.
Exclusion Criteria:
* Participant no longer wishing to participate in the study, or during the study with refusal to use data until the time of the study exit;
* A change in the background treatment of PD will not systematically justify leaving the study but will be evaluated by the scientific committee on a case-by-case basis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Years
Maximum Age:
94 Years
Study:
NCT04543058
Study Brief:
Protocol Section:
NCT04543058