N/A
N=26
Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
Stroke · Hemiparesis · Lower Extremity Paresis
Bottom Line
View on ClinicalTrials.gov: NCT01029912 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in Lower Extremity Fugl-Meyer Score at End of Treatment — 0.93; 1.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrical stimulator (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lower Extremity Fugl-Meyer Score at End of Treatment |
0.93; 1.8 | — |
| PRIMARY Change in Gait Velocity (cm/Sec) at End of Treatment |
3.0; 1.2 | — |
| PRIMARY Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP). |
-9.6; -3.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01029912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.