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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT06885502
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting an ischemic or intracerebral haemorrhagic stroke, ≥ 3 months post-stroke.
* Age \> 18 years old
* Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC \>2).
* ARAT: \<50, inclusive, to avoid ceiling effects while allowing room for improvement.
* Able to sit on a chair or a wheelchair to interact with the RGS system.
* Minimal experience with smartphone technology based on the clinician's opinion
* Willing to participate and agree to comply with the trial scheme and procedures
* Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study.
Exclusion Criteria:
* Presence of a condition or abnormality that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the data.
* Severe cognitive capabilities that prevent the execution of the study, evaluated by the MoCA \< 19 or based on the clinician's opinion.
* Pre-stroke history of upper limb motor disability.
* Unable to use the RGS independently, according to the clinician's observations, and needing more support from a caregiver to use the RGS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06885502
Study Brief:
Protocol Section:
NCT06885502