Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors

Completed · Not applicable

Conditions studied: Stroke, Hemiparesis, Lower Extremity Paresis

In brief

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.

Key facts

Study ID

NCT01029912

Run by

MetroHealth Medical Center

People needed

26

Starts

2009-11-01

Expected to finish

2011-08-01

Last updated by the study team

2017-12-07

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 to 80 years
• >6 months from a first clinical non-hemorrhagic or hemorrhagic stroke
• Medically stable
• Unilateral lower extremity hemiparesis
• Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council (MRC) scale, while seated
• Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an ankle-foot orthosis (AFO).
• AFO is clinically indicated (footdrop during ambulation or inefficient gait patterns)
• Neuromuscular electrical stimulation (NMES) of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
• Full voluntary dorsiflexion of the contralateral ankle
• Skin intact on hemiparetic lower extremity
• Able to don the NMES system or caregiver available to assist with device if needed.
• Able to hear and respond to stimulator auditory cues
• Able to follow 3-stage commands
• Able to recall 2 of 3 items after 30 minutes

You may not qualify if…

• Brainstem stroke
• Severely impaired cognition and communication
• History of peroneal nerve injury
• History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
• Uncontrolled seizure disorder
• Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
• Edema of the affected lower extremity
• Absent sensation of lower leg and foot
• Evidence of deep venous thrombosis or thromboembolism
• History of cardiac arrhythmias with hemodynamic instability
• Cardiac pacemaker or other implanted electronic system
• Botulinum toxin injections to any lower extremity muscle in the last 3 months
• Pregnancy
• Currently receiving Physical Therapy for the lower extremity

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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