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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT06374927
Eligibility Criteria:
Inclusion Criteria:
1. Patients presenting an ischemic or intracerebral haemorrhagic stroke
2. Age \> 18 years old
3. Moderate to mild proximal upper limb motor impairment Medical Research Council Scale (MRC≥2).
4. Lesion localisation by clinical symptoms/signs.
5. Able to sit on a chair or a wheelchair to interact with the RGS system.
6. Minimal experience with smartphone technology based on the clinician's opinion
7. Willing to participate and agree to comply with the trial scheme and procedures
8. Must sign an Informed Consent Form (ICF) indicating that they understand the purpose and the procedures of the study.
Exclusion Criteria:
1. 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.
2. Severe cognitive capabilities that prevent the execution of the experiment, either evaluated by the MoCA \< 19 or based on the clinician's opinion.
3. Arteriovenous malformation or lesions not related to a stroke.
4. Severe associated impairments such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia, or apraxia), major pain, or other neuromuscular impairments.
5. Pre-stroke history of upper limb motor disability.
6. Unable to use the RGS independently according to the clinician's observations and lacking support from a caregiver to use the RGS.
7. Refusal to sign the consent form.
8. No experience with smartphone technology or based on the clinician's opinion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06374927
Study Brief:
Protocol Section:
NCT06374927