Footdrop, Hemiparesis, Stroke
Conditions
Keywords
stroke, hemiplegia, footdrop, electrical stimulation
Brief summary
This is a small pilot randomized controlled trial which will enroll both subacute (\<6 mos) and chronic (\>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.
Interventions
DEVICEContralaterally Controlled Neuromuscular Electrical Stimulation
DEVICECyclic Neuromuscular Electrical Stimulation
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 21 to 75 years * Minimum of 2 wks 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 scale, while seated * NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain. * Full voluntary ROM of the contralateral ankle * Skin intact on bilateral lower extremities * 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 * Cognition and communication adequate for safe use of the device based on neurological assessment by physician principal investigator
Exclusion criteria
* 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 paretic lower extremity * Absent sensation of paretic lower extremity * 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 * Symptomatic peripheral neuropathy * Current use of psychoactive medications (except selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants) * Acetylcholinesterase inhibitor usage * Unstable asthmatic condition * Metallic implants (including clips and/or wires) * Prosthetic heart valves * Cardiac, renal or other stent * History of claustrophobia * Low visual acuity * Body weight or body habitus not compatible to MRI machine * Medical, psychological, or social concern identified by the principal investigator or co-investigator which suggests inappropriateness of subject participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Extremity Fugl-Meyer Score at End of Treatment | Baseline and End of Treatment (6 weeks) | 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 (i.e., full scale range 0-34). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10-Meter Walk Test | Baseline and End of Treatment (6 weeks) | Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged. |
| Change in Ankle Movement Tracking Error at End of Treatment | Baseline and End of Treatment (6 weeks) | Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point. Lower errors are considered to be better outcomes. For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement. |
| Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment | Baseline and End of Treatment (6 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CCNMES Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
Contralaterally Controlled Neuromuscular Electrical Stimulation | 2 |
| Cyclic NMES Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.
Cyclic Neuromuscular Electrical Stimulation | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | no longer met inclusion criteria | 1 | 0 |
| Overall Study | withdrew due to shoulder pain | 1 | 0 |
Baseline characteristics
| Characteristic | CCNMES | Cyclic NMES | Total |
|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 7.1 | 57 years STANDARD_DEVIATION 31.8 | 44.2 years STANDARD_DEVIATION 28.7 |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
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 (i.e., full scale range 0-34). 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.
Time frame: Baseline and End of Treatment (6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CCNMES | Change in Lower Extremity Fugl-Meyer Score at End of Treatment | 1 units on a scale | Standard Deviation 1.4 |
| Cyclic NMES | Change in Lower Extremity Fugl-Meyer Score at End of Treatment | 1.7 units on a scale | Standard Deviation 2.9 |
Secondary
Change in 10-Meter Walk Test
Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.
Time frame: Baseline and End of Treatment (6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CCNMES | Change in 10-Meter Walk Test | 2.2 seconds | Standard Deviation 7.6 |
| Cyclic NMES | Change in 10-Meter Walk Test | 0.5 seconds | Standard Deviation 1.7 |
Secondary
Change in Ankle Movement Tracking Error at End of Treatment
Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point. Lower errors are considered to be better outcomes. For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement.
Time frame: Baseline and End of Treatment (6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CCNMES | Change in Ankle Movement Tracking Error at End of Treatment | -2.6 units on a scale | Standard Deviation 4.6 |
| Cyclic NMES | Change in Ankle Movement Tracking Error at End of Treatment | 4.0 units on a scale | Standard Deviation 3.4 |
Secondary
Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment
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.
Time frame: Baseline and End of Treatment (6 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CCNMES | Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment | 2.5 seconds | Standard Deviation 9.6 |
| Cyclic NMES | Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment | -16.1 seconds | Standard Deviation 11.1 |