Stroke Clinical Trial
Official title:
Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke
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.
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.
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