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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05970367
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
2. A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:
1. Stroke: Participants must have received a diagnosis of stroke for the first time, have been diagnosed at least 3 months ago, and live at home.
2. SCI: Participants have a rating A, B, C or D on the American Spinal Injury Association (ASIA) measurement scale, which refers to patients with complete or incomplete impairment. All levels of SCI can be included, if there is a clear patient need linked to the upper and/or lower extremities.
3. At least 3 months post discharge from hospital/rehabilitation centre, living at home;
4. Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);
5. Had a normal functional state prior to the pathology: a pre-pathology Barthel Index \> 85/100;
6. Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum score in all affected limbs = motricity index: score 5 on 3/3 segments)
7. Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist;
8. Age of \> 18 years;
9. Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;.
Exclusion Criteria:
1. Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist;
2. No ability to initiate movements against gravity in the upper and lower limbs;
3. Severe visual impairment, communication, cognitive and language formation problems that would prevent the intervention and measurement process, assessed by a specialist;
4. Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP;
5. Female who is pregnant, breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05970367
Study Brief:
Protocol Section:
NCT05970367