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:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2025-12-26 @ 10:37 AM
NCT ID:
NCT05740228
Eligibility Criteria:
Inclusion Criteria:
1. age ≥ 18 years,
2. first haemorrhagic or ischemic stroke,
3. time since stroke ≥ 12 months,
4. unilateral lower limb hemiparesis with a Fugl-Meyer score (lower limb portion) less than 28 (out of a maximum score of 34),
5. walking deficit with a Functional Ambulation Categories (FAC) score of more than 3,
6. able to walk for 6 minutes with or without a walking aid, with or without a break, at a self-determined comfort pace,
7. ability to concentrate and follow the study protocol,
8. have given informed consent
Exclusion Criteria:
1. second stroke during the protocol,
2. botulinum toxin injection less than 3 months before the start of the protocol,
3. impaired alertness with a Montreal Cognitive Assessment (MoCA) score below 23,
4. metal object or implant near the stimulated area,
5. pacemaker,
6. vestibular disorders or vertigo,
7. severe dystonia or spasticity with a Modified Ashworth Scale score of 3 or more,
8. history of migraine,
9. severe osteoarticular comorbidities of the lower limb,
10. patients with one or more epileptic seizures,
11. severe language impairment,
12. other neurological or psychiatric disorder with severe impact on motor skills and activities of daily living, such as neurodegenerative disease, Parkinson's disease and others,
13. Pregnant woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05740228
Study Brief:
Protocol Section:
NCT05740228