Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation

Recruiting

Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Age ≥ 21 and ≤ 80
- ≤ 6 months 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
- MRC ≤ 4 for finger extensors on paretic side
- 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 FMA ≥ 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 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, PD, SCI, TBI, MS).
- 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 (>=13 on BDI-fast screen)