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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT03323632
Eligibility Criteria:
Inclusion Criteria:
1. Ischemic or hemorrhagic stroke confirmed by MRI or CT scan
2. Sub-acute subjects at least 10 days post stroke. Chronic subjects at least 6 months post stroke
3. Chedoke-McMaster Stroke Assessment Stage 1-2 (arm and hand)
4. Severe hemiplegia of the upper extremity defined as UE-FMA score of less than or equal to 19
5. Subject is able to follow instructions
6. Subject is able to sit and participate in one hour of upper limb therapy
7. Anticipated to be discharged home or already at home following conventional inpatient rehabilitation
8. Willing to attend outpatient therapy if chronic or late sub-acute
9. Subject is able and willing to give written informed consent
10. Men and women aged 18 or older
Exclusion Criteria:
1. Global Aphasia
2. Previous history of clinical stroke either ischemic infarct, hemorrhagic and subarachnoid bleeding
3. Upper extremity injury or condition prior to stroke that limits the function of the hand or arm
4. Life expectancy of less than 12 months due to other illness
5. Subject has malignant skin lesion on the affected upper extremity
6. Subject has history of seizure disorder and on seizure medications
7. Subject has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation)
8. Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS)
9. Subject has rash or open wound at any potential electrode site
10. In the judgment of the medical provider, subject has medical complications that may interfere with the execution of the study
11. Botulinum toxin (Botox) injection into affected upper extremity at least 3 months before the study or during the study
12. Currently enrolled in another upper limb study
13. Enrolled in the past six months in a clinical study involving drugs or biologics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03323632
Study Brief:
Protocol Section:
NCT03323632