Focus of the Report: This Health Technology Assessment focuses on the use of functional electrical stimulation (FES) for treatment of foot drop in patients who have a history of stroke < 1 year prior to FES treatment. A mean 1-year threshold was implemented to ensure that the majority of enrolled patients within each study were was in the acute or subacute phase of rehabilitation from stroke. The goals of this therapy are to improve gait, walking speed, quality of life, and overall functional mobility.

Technology Description: FES uses electrical pulses applied to the common peroneal nerve to recreate the muscle contractions and movements of normal voluntary gait (lifting the foot as it swings forward and placing it correctly on the ground). For skin-surface FES, electrodes placed over the nerve are connected to a stimulator unit, which provides control that can be facilitated by a foot switch or remote programming. In patients with foot drop due to stroke, FES may be used as an assistive device worn daily to facilitate walking and other activities of daily living or as a short-term rehabilitative intervention aimed at enabling users to regain the ability to move voluntarily.

Controversy: Recovery of function occurs most rapidly during the first few weeks and months after stroke, and any benefits of FES treatment may be difficult to detect during this time frame. Furthermore, in patients who still have foot drop after the early phase of stroke recovery, FES devices may not provide greater improvements in walking than ankle-foot orthoses (AFOs), despite the greater complexity and expense of FES devices.

Key Questions:

  • Does FES used for rehabilitative or assistive purposes in the acute or subacute phase of stroke recovery improve gait and quality of life in adult patients who have foot drop related to stroke?

  • How does FES compare with clinical standards for treatment of foot drop due to stroke during the acute or subacute phase of stroke recovery?

  • Is FES treatment associated with any safety issues in patients who have a history of stroke in the previous year?

  • Have definitive patient selection criteria been established for FES treatment of foot drop in the acute or subacute phase of stroke recovery?

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