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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT07273058
Eligibility Criteria:
Inclusion criteria:
* Age of 40-80 years;
* a history of ischemic stroke resulting in unilateral limb impairment 6-60 months prior to consent to participate in the pilot trial;
* a stable medical condition;
* a subjective feeling of fatigue, defined as a period of apparent fatigue, decreased energy, increased need for rest, or fatigue out of proportion to physical activity for at least 2 weeks during the past month;
* ability to communicate with the investigators and lack of significant cognitive deficits;
* able to walk for 10 meters with or without a walking aid.
Exclusion criteria:
* An FSS score of \< 4 (20);
* other neurological conditions;
* other musculoskeletal comorbidities that would prevent safe participation in exercises;
* a medical diagnosis of significant cardiovascular, pulmonary, or metabolic disease(s);
* signs or symptoms indicative of significant cardiovascular, pulmonary, or metabolic disease(s) during the previous 3 months;
* severe lower limb spasticity (Ashworth Scale score ≥ 3);
* Botulinum toxin use in the affected lower limb within the past six months;
* current or previous use of drugs intended to resolve post-stroke fatigue;
* active engagement in other stroke rehabilitation trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT07273058
Study Brief:
Protocol Section:
NCT07273058