Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
Condition: Stroke; Hemiparesis; Lower Extremity Paresis
MeSH terms: Muscle Weakness; Stroke; Paresis
Study type: Interventional

Summary: 
      Ankle dorsiflexor weakness (paresis) is one of the most frequently persisting consequences of
      stroke. The purpose of this exploratory study is to compare two different treatments --
      Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) and Cyclic
      Neuromuscular Electrical Stimulation (cNMES) -- for improved recovery of ankle movement and
      better walking after stroke.
    

Detailed description: 
      Ankle dorsiflexor weakness results in inefficient and unstable gait. While routine physical
      therapy is beneficial, for many individuals it remains limited in its effectiveness, and
      consequently many stroke survivors have difficulty walking safely or remain non-ambulatory.
      Ankle-foot-orthoses (AFOs) are often prescribed to provide ankle stability, but because they
      limit ankle mobility they may actually inhibit recovery of dorsiflexion. Advanced
      rehabilitation techniques that emphasize active, repetitive, goal-oriented movement of the
      impaired limb have produced measurable functional improvements, yet a significant degree of
      lower extremity disability often remains. In addition, some of these emerging therapies are
      difficult to administer and are applicable only to patients who retain at least some degree
      of ambulation. Thus, there is a need for alternative treatments.

      This is an exploratory study of an innovative neuromuscular electrical stimulation (NMES)
      treatment for restoring lower extremity motor control following stroke. We will investigate
      whether stroke survivors with chronic footdrop recover voluntary ankle dorsiflexion after a
      novel treatment of NMES. Surface electrodes will deliver stimulation to dorsiflex the ankle
      with an intensity that is proportional to the amount of dorsiflexion of the other unimpaired
      ankle. Thus, voluntary dorsiflexion of the unaffected ankle produces stimulated dorsiflexion
      of the affected ankle. We refer to this stimulation paradigm as Contralaterally Controlled
      Neuromuscular Electrical Stimulation (CCNMES). In contrast to existing peroneal nerve
      stimulators, CCNMES is not intended to be used to assist ambulation; rather it is intended as
      solely a motor retraining paradigm that may reduce lower extremity impairment and improve
      ambulation. The primary objective of the proposed study is to obtain pilot data so that an
      estimate can be made of the efficacy of CCNMES in reducing lower extremity impairment and
      improving ambulation.

      Twenty-six chronic stroke survivors (>6 months post-stroke) will be randomized to either
      CCNMES or cyclic NMES, an intervention that provides electrical stimulation of the ankle
      dorsiflexors, but with preprogrammed timing and intensity. For both groups, the treatment
      will last 6 weeks. Assessments of ankle impairment and ambulation will be made at baseline
      and at end of treatment.

      This study is the first randomized controlled trial of CCNMES for restoring ankle
      dorsiflexion in patients with chronic hemiplegia.
    

Intervention name(s): Electrical stimulator
Intervention type(s): Device
Intervention description(s): 6-week intervention
15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week.
Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Hemiplegia; Footdrop; Electrical Stimulation; Motor Relearning; Neuroplasticity