Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke

Stroke is the leading cause of activity limitation among older adults in the United States.
NeuroMuscular Electrical Stimulation (NMES) can be used by stroke survivors who do not have
enough residual movement to take part in volitional active repetitive movement therapy and
does not require expensive equipment or skilled personnel. Two types of NMES are available.
The first is cyclic NMES, which electrically activates paretic muscles at a set duty cycle
for a preset time period. (This study will employ both "traditional" cyclic stimulation and
"sensory-only" stimulation, in which intensity is set at a level to be felt by the patient
but insufficient to cause muscle contraction.)In cyclic NMES, the patient is a passive
participant and does not assist the NMES by volitionally contracting the muscle during
stimulation. The second type encompasses various forms of NMES in combination with
biofeedback. For example, in "EMG-triggered" NMES, subjects are "rewarded" with stimulation
in response to successful attempts to reach a pre-set level of EMG activity in the affected
muscle. There is increased cognitive input and involvement on the part of the patient. The
purpose of this study is to first demonstrate the effectiveness of these two types of surface
stimulation on decreasing motor impairment and activity limitation; the study also seeks to
assess the effect of adding cognitive input to NMES to reduce motor impairment and activity
limitation.

Study subjects will be acute stroke survivors. They will participate for a total of eight
months, beginning within the first six months after their stroke. Subjects will be randomly
assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic
stimulation; 2)Sensory-only stimulation; and 3)EMG-triggered stimulation. Members of each
treatment group will be given an appropriate NMES device to use for two 40-minute treatment
sessions per day, five times per week for eight weeks; for a total of 80 treatment sessions.
Stimulation will be applied to ECR and EDC (wrist and finger extensors) on the affected arm.
A treatment therapist will visit the patient at home on a weekly basis to monitor subject
compliance and to provide feedback on device usage. The primary outcome measure will be the
upper extremity portion of the Fugl-Meyer Motor Assessment (FMA), a measure of motor
impairment. The modified Arm Motor Ability Test (mAMAT) is a hemiparetic arm-specific measure
of activity limitation, and will serve as a secondary outcome measure.

In addition to the baseline visit on day of enrollment, subjects will complete these outcome
measurements at the clinic on five other occasions: at mid-treatment (week 5); end of
treatment (week 9); and for follow-up visits at one-, three- and six-months post-treatment.

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