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:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT04188132
Eligibility Criteria:
Inclusion Criteria:
* • age: 21-75 years
* Subacute or chronic stroke; interval of at least 3 months and interval of at least 6 months from stroke to time of enrollment, respectively.
* no cerebellar signs or bilateral motor deficit
* Cognitive ability to consent, assimilate, and participate actively in the treatment protocol (Mini Mental State Examination score \> 24 points, out of a total 30 indicating normal cognitive ability);
* Modified Rankin scale scores 1-3 (Mild-Moderate functional disability post-stroke);
* Modified Ashworth Scale of Spasticity score \<= 3 (ranges from 0-4 with 4 reflecting maximum spasticity)
* No epilepsy /usage of antiepileptic drug
◦ Subjects with Stroke will be included if they have:
* unilateral impaired upper limb
* Able to initiate hand movements like opening and closing fist and no joint contracture or severe spasticity in the affected upper limbs.
* Sufficient sitting balance to participate in experimental activities.
* No condition (e.g. severe arthritis, central pain) that would interfere with the administration of motor function tests.
* English-language comprehension and cognitive ability sufficient to give informed consent (MMSE \>=24) and to cooperate with the intervention.
Exclusion Criteria:
* • Orthopedic conditions of either upper or lower extremity that would affect performance on the study
* untreated depression that may affect motivation to participate in the study
* vascular cognitive impairment interfering with comprehending the tasks
* Individuals with stroke who have been diagnosed with cognitive or severe visual deficits, hemineglect, uncontrolled angina, or pregnancy
* no psychiatric or neurological condition other than stroke
◦ Stroke will be excluded if they have:
* Pregnancy (Self -reported)
* Dementia (MMSE score less than 24)
* Recurrence of stroke (Occurrence of new focal deficits reported by patient or detected by PI on examination during visits)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT04188132
Study Brief:
Protocol Section:
NCT04188132