Functional Electrical Stimulation for Footdrop in Hemiparesis

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Odstock Dropped-Foot Stimulator (ODFS) Device
    Intervention Desc: Device implementation & use for ~13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
    ARM 1: Kind: Experimental
    Label: ODFS
    Description: Odstock Dropped-Foot Stimulator (ODFS)
  • Conventional Standard of Care Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Standard of Care (inc. AFO)
    Description: Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO))
  • Traditional Physical Therapy Treatment Procedure
    Intervention Desc: Traditional physical therapy treatment for 12 weeks.
    ARM 1: Kind: Experimental
    Label: ODFS
    Description: Odstock Dropped-Foot Stimulator (ODFS)
    ARM 2: Kind: Experimental
    Label: Standard of Care (inc. AFO)
    Description: Conventional Standard of Care (which may include a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO))

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Motor Assessment (FMA) Weeks 0, 12, 24, 36 No
Secondary Quantitative Gait Analysis Weeks 0, 12, 24, 36 No
Secondary Modified Emory Functional Ambulation Profile(mEFAP) Weeks 0, 12, 24, 36 No
Secondary Stroke-Specific Quality of Life Scale (SS-QOL) Weeks 0, 12, 24, 36 No
Secondary Electronic Activity Monitor (activPAL) - 3 day monitor Weeks 0, 12, 24, 36 No
Secondary Optional Quantitative Gait Analysis of Orthotic Effect of ODFS vs. AFO Once in Weeks 6-12 No

Sponsors