Neural Prostheses and Gait Performance: Model-Based Strategies
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Purpose
The purpose of this research is to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability. FES involves applying small electric currents to the nerves, which cause the muscles to contract.
FES research projects vary from simple investigations of the therapeutic effects of exercise on muscle function and skin health, to more complex studies of functional movements such as standing or walking.
| Condition | Intervention |
|---|---|
|
Hemiplegia |
Device: EMS 2000 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Neural Prostheses and Gait Performance: Model-Based Strategies |
- Walking stability and speed [ Time Frame: Within 3 mos. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Case-control study: pre- and post-stimulation (FES).
|
Device: EMS 2000
Surface stimulation to contract the muscles in the lower extremity
|
Detailed Description:
The study aims to find the optimal patterns of functional electrical stimulation (FES) of muscles in the lower legs that will improve walking ability in those who have had a stroke and at the same time ensure walking stability will be achieved through an analytical approach comprised of computational models and gait simulations to objectively determine patient-specific patterns of muscle activation. We will develop a computer simulation of the dynamics of hemiplegic gait characterized by unilateral plantarflexor weakness. Then, we will relate the results of the computer model results to real data collected from subjects with known plantarflexor weakness to provide a theoretical basis for improving gait efficiency and stability with FES.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
This study includes stroke survivors greater than 18 years of age, >180 days from first clinical hemorrhagic or nonhemorrhagic stroke with:
- Unilateral hemiparesis with sufficient endurance and motor ability to ambulate >30 feet continuously without an AFO requiring no more than 25% physical help
- Berg Balance Scale score >23 without assistive devices
- Standing ankle dorsiflexion strength of <4/5
- Foot-drop during ambulation with gait instability or inefficient gait defined as supervision need
- Possible use of physical assistance or assistive device (cane, walker)
- Evidence of foot-drop as seen by "dragging" or "catching" of affected toes during limb swing or circumducting affected limb
- Vaulting of the unaffected limb or hiking the affected hip to clear toes.
- Intact and electrically ex-citable lower motor neurons
- Ankle dorsiflexion to at least neutral while standing with electrical stimulation of common peroneal and tibial nerves without painful hypersensitivity to stimulation
- Adequate social support and stability
- Medically stable with intact skin in affected lower limb
- Willingness to comply during research procedures
- No systemic co-morbidities
- No history of potentially fatal cardiac arrhythmias i.e. ventricular tachycardia, supraventricular tachycardia and rapid ventricular response atrial fibrillation with hemodynamic instability
- No psychological problems or chemical dependency
- No acute medical complications such as depression or chronic anxiety requiring long term pharmacological therapy. Able-bodied controls must be of similar age, body mass and stature as those with hemiparesis and must be free of any medical and disabling orthopedic problems.
Exclusion Criteria:
In addition to failure to meet the inclusion criteria, participants will be excluded from the study for the following:
- Requires an AFO to prevent knee flexion collapse in stance
- Excessive edema of affected extremity
- Absent sensation in affected 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 implanted electronic systems
- Pregnancy
- Uncontrolled seizure disorder
- Ipsilateral lower limb lower motor neuron lesion
- Parkinson's disease
- Spinal cord injury
- Traumatic brain injury
- Multiple sclerosis
- Ankle plantar flexor contraction
- Severely impaired cognition and communication
- Painful hypersensitivity to neuromuscular stimulation of common peroneal nerve
- Knee hyperextension (genu recurvatum) that cannot be adequately corrected with peroneal nerve stimulation
- History of botulinum toxin to the lower extremity within the prior three months.
Contacts and Locations| Contact: Jeanne F Marlow, RN | (217) 791-3800 ext 4236 | jeanne.marlow@va.gov |
| Contact: Lisa M Lombardo, MPT | (216) 791-3800 ext 4909 | llombardo@fescenter.org |
| United States, Ohio | |
| VA Medical Center, Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Jeanne F Marlow, RN 217-791-3800 ext 4236 jeanne.marlow@va.gov | |
| Contact: Lisa M Lombardo, MPT (216) 791-3800 ext 4909 llombardo@fescenter.org | |
| Principal Investigator: Elizabeth C Hardin, PhD MS | |
| Principal Investigator: | Elizabeth C Hardin, PhD MS | VA Medical Center, Cleveland |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00991406 History of Changes |
| Other Study ID Numbers: | B4668-R |
| Study First Received: | October 2, 2009 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Electric Stimulation Hemiplegia walking |
Additional relevant MeSH terms:
|
Hemiplegia Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013