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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01688856
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 21 and ≤ 80
* ≤ 2 years of first clinical hemorrhagic or nonhemorrhagic stroke
* Skin intact on hemiparetic arm and hand
* Able to follow 3-stage commands
* Able to recall 2 of 3 items after 30 minutes
* Medically stable
* Finger extensor paresis indicated by a score of ≤ 4 out of 5 on the manual muscle test (Medical Research Council scale)
* Adequate movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
* Caregiver available to assist with device daily - OR - able to independently don elbow cuff on unaffected arm
* Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
* Upper extremity hand section of Upper Extremity Fugl-Meyer (UEFM)≥ 1 AND ≤ 11/14
* Unable to simultaneously fully extend the elbow and fully open the hand toward tabletop object with arm unsupported (i.e. cannot voluntarily achieve the maximum passive range of motion (PROM) available)
* Functional PROM (minimal resistance) at shoulder, elbow, wrist, and hand simultaneously on affected side (i.e., there exists enough PROM to reach and acquire table-top objects).
* Able to hear and respond to stimulator cues
* While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
* While relaxed with the forearm supported with a mobile arm support, surface NMES of elbow extensors (triceps) produces functional elbow extension without pain.
* Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment.
Exclusion Criteria:
* Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's Disease, Spinal Cord Injury, Traumatic Brain Injury, Multiple Sclerosis).
* Severely impaired cognition and communication
* Uncontrolled seizure disorder
* History of cardiac arrhythmias with hemodynamic instability
* Cardiac pacemaker or other implanted electronic device
* Pregnant
* IM Botox injections in any UE muscle in the last 3 months
* Insensate arm, forearm, or hand
* Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
* Severe shoulder or hand pain
* Severe depression on Beck Depression Inventory (BDI) (score\>=13 on BDI-fast screen)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT01688856
Study Brief:
Protocol Section:
NCT01688856