Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
Condition: Stroke, Acute; Stroke; Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): NMES device with EMG-triggered and Cyclic capabilities
Intervention type(s): Device
Intervention description(s): All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles.
Other intervention name(s): NeuroMove NM900 stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; recovery of function; functional electrical stimulation (FES)