Functional Electrical Stimulation for Footdrop in Hemiparesis
Condition: Stroke; Hemiplegia
MeSH terms: Hemiplegia; Paresis
Study type: Interventional

Summary: 
      The objective of this research is to determine if electrical stimulation can improve the
      strength and coordination of the lower limb muscles, and the walking ability of stroke
      survivors.

      The knowledge gained from this study may lead to enhancements in the quality of life of
      stroke survivors by improving their neurological recovery and mobility. The results may lead
      to substantial changes in the standard of care for the treatment of lower limb hemiparesis
      after stroke.
    

Detailed description: 
      Hemiplegia is a major consequence of stroke and contributes significantly to the physical
      disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during
      the swing phase of gait, and ankle instability during stance phase, are important gait
      abnormalities that contribute to reduced mobility among stroke survivors. In the United
      States, the standard of care in addressing these deficits is the custom molded
      ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive
      movement training is the principal substrate for facilitating motor relearning after stroke.
      Motor relearning is defined as the reacquisition of motor ability after central nervous
      system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term,
      it is possible that it also inhibits recovery in the long-term. Previous studies have
      demonstrated that active repetitive movement exercises mediated by neuromuscular electrical
      stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies
      have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for
      foot-drop experience sufficient recovery that they no longer need the peroneal nerve
      stimulator or an AFO for community ambulation. However, there are no blinded randomized
      clinical trials that rigorously evaluate the motor relearning effects of ambulation training
      with peroneal nerve stimulators. Thus, the primary aim of this project is to assess the
      effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among
      chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous
      peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A
      single-blinded randomized clinical trial will be carried out to assess the effects of
      ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared
      to ambulation training with conventional standard of care (which may include an AFO).
      Subjects will be treated for 12 weeks and followed for a total of another 6 months. This
      project will determine the effectiveness of peroneal nerve stimulation in facilitating motor
      relearning and improving the mobility and quality of life of stroke survivors. This proposed
      approach is expected to improve patient outcome and challenge the present clinical paradigm
      of prescribing AFOs for stroke survivors with foot-drop.
    

Intervention name(s): Odstock Dropped-Foot Stimulator (ODFS); Conventional Standard of Care; Traditional Physical Therapy Treatment
Intervention type(s): Device; Other; Procedure
Intervention description(s): Device implementation & use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.; Conventional standard of care (which may include implementation & use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.; Traditional physical therapy treatment for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemiplegia; hemiparesis; stroke; foot-drop; electrical stimulation; ankle-foot-orthosis