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Table 1 Eligibility criteria

From: Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial

Inclusion
1. Age 21 to 90 years old at time of randomization
2. 6 to 24 months since a first clinical cortical or subcortical, ischemic, or hemorrhagic stroke
3. Unilateral upper limb hemiparesis with finger extensor strength of ≤4 out of 5 on the Medical Research Council scale
4. Score of ≥1 and ≤11 out of 14 on the hand section of the Upper Extremity Fugl-Meyer assessment (these define a degree of reduced hand strength and coordination that significantly limits use of the paretic hand in activities of daily living)
5. Able to follow 3-stage commands
6. Able to recall at least 2 of a list of 3 items after 30 min
7. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
8. Skin intact on hemiparetic arm
9. Surface electrical stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude individuals who have too much flexor spasticity)
10. Able to hear and respond to cues from the stimulator
11. Not receiving occupational therapy
12. Full volitional hand opening/closing of contralateral hand
13. Demonstrates ability to follow instructions for putting on and operating the assigned stimulator or has caregiver to assist (if applicable)
Exclusion
1. Concomitant neurologic diagnosis of peripheral nerve injury, Parkinson’s disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
2. Brainstem stroke
3. Uncontrolled seizure disorder, defined as having a seizure within the previous 3 months
4. Severe shoulder or hand pain, i.e., unable to position hand in the workspace without pain
5. Lack of functional passive range of motion of the wrist or fingers of affected side
6. Insensate to touch on forearm or hand
7. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
8. History of potentially fatal cardiac arrhythmias with hemodynamic instability
9. Cardiac pacemaker or other implanted electronic system
10. Diagnosis (apart from stroke) that substantially affects paretic arm and hand function
11. Deficits in communication that interfere with reasonable study participation
12. Lacking sufficient visual acuity to see the stimulator’s display
13. Botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
14. Pregnancy
15. Concurrent enrollment in another investigational study
Additional exclusion criteria for participating in the neurophysiological assessments (Cleveland site only)
16. Metal in the head or neck
17. Conditions that affect sensorimotor system: brain tumor(s), diabetic neuropathy, Parkinson’s disease
18. Seizure history or history of fainting spells of unknown/undetermined etiology
19. Alcohol or substance abuse disorder
20. Deep brain stimulator, shunts, nerve stimulators, pace-making, or pace-recording devices
21. Current diagnosis of carpal tunnel syndrome
22. Previous adverse reaction to transcranial magnetic stimulation (TMS)
23. Medications with potential to alter seizure threshold, e.g., buproprion