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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT01847157
Eligibility Criteria:
Inclusion Criteria:
1. first ever ischemic or hemorrhagic stroke patients identified by computed tomography (CT) or magnetic resonance imaging (MRI)
2. age between 40 and 80 years old
3. have a stroke over 6 months
4. unilateral hemiplegia
5. Fugl-Meyer assessment-upper extremity (FMA-UE) score≦29 when selection
6. poststroke elbow flexor spasticity less than 2 using modified Ashworth scale (MAS)
7. no severe anesthesia (FMA sensory test, upper extremity score≧10 )
8. no wrist and finger joint pain
9. clear consciousness, can understand simple sentences and spoken orders, and co-operate manipulation
10. can accept motor training in the sitting position for approximately 30 minutes.
Exclusion Criteria:
1. Suffer from other orthopedic diseases (such as severe arthritis), nerve damage (such as peripheral nerve damage), or severe pain, which influences upper extremity motor
2. have a medical history or family history of epilepsy
3. regularly take central nervous system drugs (such as sedatives), or the Class III antiarrhythmic drugs (such as amiodarone)
4. have atopic dermatitis or skin disorders of the scalp
5. have allergy to anesthetic medicines of the acyl amine
6. have a metal implant in the head or neck, or serious arrhythmia (the heartbeat is less than 50 beats per minute or higher than 100 beats per minute); or use a pacemaker or atrial defibrillator
7. suffer from congenital or idiopathic methemoglobinemia. Aphasia is not an exclusion criterion, but the patients should understand simple spoken orders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01847157
Study Brief:
Protocol Section:
NCT01847157