Stroke Clinical Trial
Official title:
Contralaterally Controlled NMES in Chronic Ankle Dorsiflexor Paresis After Stroke
Verified date | November 2017 |
Source | MetroHealth Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | MetroHealth Medical Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
MetroHealth Medical Center | Case Western Reserve University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Khaslavskaia S, Sinkjaer T. Motor cortex excitability following repetitive electrical stimulation of the common peroneal nerve depends on the voluntary drive. Exp Brain Res. 2005 May;162(4):497-502. Epub 2005 Feb 9. — View Citation
Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. — View Citation
Knutson JS, Hisel TZ, Harley MY, Chae J. A novel functional electrical stimulation treatment for recovery of hand function in hemiplegia: 12-week pilot study. Neurorehabil Neural Repair. 2009 Jan;23(1):17-25. doi: 10.1177/1545968308317577. Epub 2008 Sep 23. — View Citation
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Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair. 2006 Sep;20(3):355-60. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Lower Extremity Fugl-Meyer Score at End of Treatment | The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0. Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. |
2 timepoints: Prior to treatment, and End of treatment at 6 weeks. | |
Primary | Change in Gait Velocity (cm/Sec) at End of Treatment | Gait velocity was assessed using a motion capture and analysis system which collected spatio-temporal data as the participant walked 5-meters 10 times at a self-selected comfortable speed within the field of view of the motion capture system. A higher gait velocity is considered to be a better outcome. For each individual, the gait velocity prior to treatment was subtracted from the gait velocity at end of the 6-week treatment. Then for each treatment group, these change values were averaged. | 2 timepoints: Prior to treatment, and End of treatment at 6 weeks. | |
Primary | Change in Time (Sec) to Complete the Modified Emory Functional Ambulation Profile (MEFAP). | The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time. Lower times are considered to be a better outcome. For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged. |
2 timepoints: Prior to treatment, and End of treatment at 6 weeks. |
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