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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT00142792
Eligibility Criteria:
Inclusion Criteria:
* Age 21-89
* Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) completely resolved
* Medically stable
* Less than 6 months post-stroke
* Intact skin on the hemiparetic side
* Able to follow 3-stage commands
* Able to recall 2/3 objects after 30 minutes
* Full passive ROM at the wrist and the thumb, index and long finger MCP joints on the affected side
* Presence of a detectable, volitionally-activated EMG signal from the paretic wrist or finger extensors (ECR or EDC)
* Affected wrist extensors ≤ 4 on MRC scale
* Score of ≤ 11/14 on Section C (hand) of UE portion of Fugl Meyer Assessment (FMA)
* Ability to tolerate NMES to the ECR and EDC for full wrist and finger extension
* Caregiver available to assist with the device every day (unless subject capable of using it independently
Exclusion Criteria:
* History of ventricular arrythmias or any other arrythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability
* History of other upper motor neuron lesion
* Absent sensation of the affected limb
* Pregnancy
* History of more than one seizure per month during the last year (or, since the stroke if no seizures prior to stroke)
* Discharge to a skilled nursing facility or long-term care facility (EXCEPTION: Subjects may be d/c'd to the 6A SNF unit at MetroHealth Medical Center)
* Uncompensated hemineglect
* Implanted stimulator (such as a pacemaker)
* Evidence of hand pain as defined by current metacarpophalangeal (MCP) joint pain upon palpation and/or wrist or MCP pain upon extension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
89 Years
Study:
NCT00142792
Study Brief:
Protocol Section:
NCT00142792