N/A
N=110
Functional Electrical Stimulation for Footdrop in Hemiparesis
Stroke · Hemiplegia
Bottom Line
View on ClinicalTrials.gov: NCT00148343 ↗Enrolled (actual)
110
Serious AEs
25.5%
Results posted
Jun 2018
Primary outcome: Primary: Fugl-Meyer Motor Assessment (FMA) — 20.1; 20.3; 21.5; 21.18 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Odstock Dropped-Foot Stimulator (ODFS) (Device); Conventional Standard of Care (Other); Traditional Physical Therapy Treatment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Motor Assessment (FMA) |
20.1; 20.3; 21.5; 21.18; 21.26; 21.17 | — |
| SECONDARY Steps Per Minute |
65.0; 66.7; 67.4; 72.6; 69.3; 72.0 | <0.05 sig |
| SECONDARY Modified Emory Functional Ambulation Profile(mEFAP) |
121.54; 118.39; 107.92; 93.47; 110.81; 97.25 | <0.05 sig |
| SECONDARY Stroke-Specific Quality of Life Scale (SS-QOL) |
179.12; 175.30; 191.62; 185.42; 195.66; 184.87 | — |
| SECONDARY Gait Speed |
0.35; 0.40; 0.40; 0.47; 0.44; 0.46 | <0.05 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Stroke survivors >90 days from most recent clinical hemorrhagic or nonhemorrhagic stroke
- Age: 18-80 years
- Unilateral hemiparesis
- Medically stable
- Sufficient endurance & motor ability to ambulate at least 30 feet continuously with minimal assistance [requiring contact guard to no more than 25% physical help] or less without the use of an AFO
- Berg Balance Scale score of 24 or greater without any assistive devices
- Ankle dorsiflexion strength of no greater than 4/5 on the Medical Research Council (MRC) scale while standing
- Demonstrate foot-drop during ambulation such that gait instability [need for supervision, physical assistance or assistive device (cane, walker) to maintain balance or prevent falls] or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited
- Ankle dorsiflexion to at least neutral while standing in response to NMES of the common peroneal nerve without painful hypersensitivity to the NMES
- If using an AFO, willing to terminate its use and comply with study requirements
Exclusion Criteria
- Require an AFO to maintain knee stability (prevention of knee flexion collapse) during stance phase of gait
- Edema of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Skin breakdown of the affected lower limb which interferes with the safe and effective use of a peroneal nerve stimulator
- Absent sensation of the affected lower limb
- History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability
- Demand pacemakers or any other implanted electronic systems
- Pregnant women
- Uncontrolled seizure disorder
- Parkinson's Disease
- Spinal cord injury
- Traumatic brain injury with evidence of motor weakness
- Multiple sclerosis
- Fixed ankle plantar flexor contracture
- Peroneal nerve injury at the fibular head as the cause of foot-drop
- Uncompensated hemineglect
- Severely impaired cognition and communication
- Painful hypersensitivity to NMES of the common peroneal nerve
- Inadequate social support (potential unlikeliness to comply with treatment & follow-up)
- History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
Data sourced from ClinicalTrials.gov (NCT00148343). 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.