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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT01836159
Eligibility Criteria:
Inclusion Criteria:
* Patient has provided written consent prior to entry into the study
* Males or females, 18 - 85 years of age
* Evidence of ischemic or hemorrhagic stroke confirmed by CT or MRI head scan
* Patient with onset of symptoms less than 3 months (for iHOME Acute) or patient more than 6 months (for iHOME Chronic) at the time of randomization
* Measurable deficit of the upper extremity ≥3 according to the Chedoke McMaster scale e.g. participants should be able to touch their chin and contralateral knee to be eligible (for iHome Acute), or measurable deficit of the upper extremity ≥4 according to the Chedoke McMaster scale e.g. participants should be able to touch their chin and contralateral knee to be eligible (for iHome Chronic)
* Functional independence prior to present stroke (mRS = 0-1)
* Patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
Exclusion Criteria:
* Patient had stroke onset more than 3 months ago (for iHOME Acute) or patient had stroke onset less than 6 months ago (for iHOME Chronic)
* Inability to follow verbal commands or having global aphasia
* Severe illness with life expectancy less than 3 months
* Uncontrolled hypertension, unstable angina, or recent myocardial infarction
* History of seizures
* Participation in another clinical trial involving rehabilitation or investigational drug
* Unable to comply with the protocol
* Patient has any condition(s) that would warrant exclusion from the study
* Any medical condition that might confound the interpretation of results or put the patient at risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01836159
Study Brief:
Protocol Section:
NCT01836159