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.

Condition	Intervention	Phase
Stroke, Acute Stroke Hemiparesis	Device: NMES device with EMG-triggered and Cyclic capabilities	Phase II

Further Study Details: 

Primary Outcomes: Fugl-Meyer Motor Assessment (FMA) - motor impairment measure given on 6 occasions: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Secondary Outcomes: Arm Motor Ability Test (AMAT) - hemiparetic arm-specific measure of activity limitation given on 6 occasions as above: at baseline, mid-treatment, end of treatment, and follow-up at 1-,3- and 6-months post-treatment.
Expected Total Enrollment:  189

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. 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 during their hospital stay, and continuing after hospital discharge. Subjects will be randomly assigned to one of three treatment groups and will receive stimulation accordingly: 1) Cyclic stimulation; 2) EMG-triggered stimulation; and 3) Sensory-only stimulation (control). Members of each treatment group will be given an appropriate NMES device to use for three 30-minute treatment sessions per day, five times per week for eight weeks; for a total of 120 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 in the hospital (or at home after discharge) 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 Arm Motor Ability Test (AMAT) 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 4); end of treatment (week 8); and for follow-up visits at one-, three- and six-months post-treatment.

Ages Eligible for Study:  55 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Ages 55 to 80 • Evidence of clinical symptoms from a hemorrhagic or nonhemorrhagic stroke with all symptoms from previous stroke(s) clinically resolved • Medically stable • Moderate to mild unilateral hemiparesis • Follow 2-stage commands consistently • Sufficient hearing to hear the audio cue that will be used during treatment • Less than 12 weeks post-stroke • Full passive ROM at the wrist and all MCP joints • Subject can extend his/her affect wrist against gravity at least 10 degrees beyond neutral • Subject has MRC ≤ 4 for wrist extensors • Intact skin on the hemiparetic arm • Score of 18 or below on the Geriatric Depression Scale • Can tolerate NMES to the ECR and EDS for full wrist and finger extension • Average AMAT functional ability score ≤ 3.5 • Demonstrates presence of volitionally activated EMG signal from the paretic ECR of at least 5 μV in magnitude

Exclusion Criteria:

• History of ventricular arrhythmias or any other arrhythmias (i.e. fast atrial fibrillation, ventricular tachycardia, or supraventricular tachycardia) with hemodynamic instability • History of other upper motor neuron lesion • Ipsilateral lower motor neuron lesion • Edema in the affected limb • Pregnancy • Uncontrolled seizure disorder • Mini-Mental State Examination (MMSE) score below the 4th quartile on age-adjusted norms • Implanted stimulator (such as a pacemaker)

Please refer to this study by ClinicalTrials.gov identifier  NCT00142792

Catherine Corrigan, RN      216 778 8903    ccorrigan@metrohealth.org
Peggy Maloney, RN      216-778-8563    mmaloney@metrohealth.org

Ohio
      MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States
      University of Cincinnati College of Medicine, Cincinnati,  Ohio,  45267,  United States

Study chairs or principal investigators

John Chae, ME, MD,  Principal Investigator,  MetroHealth Medical Center   

Study ID Numbers:  R01HD049777
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142792
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06