N/A
Completed N=122
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
Stroke, Acute · Stroke · Hemiparesis
Source: ClinicalTrials.gov NCT00142792 ↗
Enrolled (actual)
122
Serious AEs
26.2%
Results posted
Mar 2018
Primary outcomePrimary: Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure — 27.5; 29.8; 26.8; 31.8 units on a scale — p=0.18
Summary
Stroke is the leading cause of activity limitation among older adults in the United States. NeuroMuscular Electrical Stimulation (NMES) can assist stroke survivors in regaining motor ability and decreasing activity limitation caused by stroke. This study will research the effects of two types of NMES on reducing motor impairment and activity limitation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Motor Assessment (FMA) - Motor Impairment Measure |
27.5; 29.8; 26.8; 31.8; 32.6; 30.4 | 0.18 |
| SECONDARY Arm Motor Ability Test (AMAT) - Hemiparetic Arm-specific Measure of Activity Limitation |
1.7; 2.0; 1.7; 2.2; 2.3; 2.0 | 0.27 |
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
Data sourced from ClinicalTrials.gov (NCT00142792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.