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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07443150
Eligibility Criteria:
Inclusion Criteria:
* First-ever unilateral ischemic stroke (right or left hemisphere) confirmed by MRI.
* Subacute phase of stroke (between 2 and 6 weeks post-incident).
* Age between 45 and 85 years.
* Balance: A score of ≥ 21/56 points on the Berg Balance Scale (BBS), ensuring the ability to safely maintain a standing position.
* Mobility: Baseline gait speed ≥ 0.4 m/s (classified as Limited Community Ambulation).
* Permitted Aids: Use of orthopedic aids (quadripod, cane, walker) and foot stabilization (e.g., Thera-Band).
* Physical Capacity: Ability to complete the 6-Minute Walk Test (6MWT) without requiring rest breaks.
* Cognitive Status: MMSE score ≥ 23 (ensuring the ability to understand and follow instructions).
* Informed, written patient consent provided in accordance with the Declaration of Helsinki.
Exclusion Criteria:
* Neurological Profile: Hemorrhagic stroke, recurrent stroke, bilateral stroke, or lesions localized in the cerebellum or brainstem.
* Functional Dependence: Requirement for constant, hands-on physical assistance from third parties to maintain upright gait (despite the use of orthopedic aids).
Medical Contraindications: Cardiorespiratory instability (e.g., uncontrolled hypertension, cardiac arrhythmia), recent fractures, or advanced degenerative joint changes preventing safe verticalization.
* Pharmacological Interference: Use of Selective Serotonin Reuptake Inhibitors (SSRIs) or other medications significantly affecting the neuroendocrine profile (e.g., hormone replacement therapy, corticosteroids).
* Communication \& Cognitive Barriers: Global or profound sensory aphasia, or severe cognitive impairment (MMSE \< 23) preventing effective cooperation.
* Co-morbidities: Any neurologic (e.g., Parkinson's disease, multiple sclerosis), orthopedic, rheumatological, or internal conditions (including active malignancy, severe systemic infections, or untreated metabolic disorders) that could interfere with the intervention's safety or the integrity of hormonal and functional assays.
* Consent: Withdrawal of consent or lack of voluntary, written consent to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT07443150
Study Brief:
Protocol Section:
NCT07443150