Stroke, Hemiplegia
Conditions
Keywords
hemiplegia, hemiparesis, stroke, foot-drop, electrical stimulation, ankle-foot-orthosis
Brief 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.
Detailed description
Hemiplegia is a major consequence of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase of gait, and ankle instability during stance phase, are important gait abnormalities that contribute to reduced mobility among stroke survivors. In the United States, the standard of care in addressing these deficits is the custom molded ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor relearning after stroke. Motor relearning is defined as the reacquisition of motor ability after central nervous system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term, it is possible that it also inhibits recovery in the long-term. Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation. However, there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators. Thus, the primary aim of this project is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb motor relearning among chronic stroke survivors. The secondary aim is to assess the effects of transcutaneous peroneal nerve stimulation on lower limb mobility (disability) and overall quality of life. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among chronic stroke survivors compared to ambulation training with conventional standard of care (which may include an AFO). Subjects will be treated for 12 weeks and followed for a total of another 6 months. This project will determine the effectiveness of peroneal nerve stimulation in facilitating motor relearning and improving the mobility and quality of life of stroke survivors. This proposed approach is expected to improve patient outcome and challenge the present clinical paradigm of prescribing AFOs for stroke survivors with foot-drop.
Interventions
DEVICEOdstock Dropped-Foot Stimulator (ODFS)
Device implementation & use for \ 13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The ODFS then will be returned to the investigators.
OTHERConventional Standard of Care
Conventional standard of care (which may include implementation & use of a study-specific Custom Molded Hinged Ankle Foot Orthosis (AFO)) for \ 13 weeks (until 2nd Outcomes Assessment (1st post-treatment Outcomes Assessment)). The AFO, if implemented, may continue to be used afterwards since it is an element of the standard of care for this patient population.
Traditional physical therapy treatment for 12 weeks.
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
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Assessment (FMA) | Weeks 0, 12, 24, 36 | Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps Per Minute | Weeks 0, 12, 24, 36 | The number of steps taken by participants in one minute |
| Modified Emory Functional Ambulation Profile(mEFAP) | Weeks 0, 12, 24, 36 | The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the timed up-and-go test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds. |
| Stroke-Specific Quality of Life Scale (SS-QOL) | Weeks 0, 12, 24, 36 | The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales. Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245. |
| Gait Speed | baseline, 12, 24 and 36 weeks | — |
Countries
United States
Participant flow
Recruitment details
Subjects screened over 5-yr study period: 469. Subjects completing informed consent and eligibility eval: 158. Subjects enrolled: 110. Last date of enrollment:10/27/2009. Final date subject study completion: 8/2/2010. All subject screening, enrollment, and study participation took place at an academic medical center.
Pre-assignment details
Enrolled subjects (n=110) were stratified by presence or absence of dorsiflexion, based on clinical exam, prior to randomization into treatment and control groups. No enrolled subjects were excluded from the trial prior to assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Peroneal Nerve Stimulation Odstock Dropped Foot Stimulator | 54 |
| Standard of Care No device or ankle foot orthosis | 56 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 3 | 4 |
| Overall Study | Withdrawal by Subject | 12 | 7 |
Baseline characteristics
| Characteristic | Standard of Care | Peroneal Nerve Stimulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 47 Participants | 98 Participants |
| Age, Continuous | 53.2 years STANDARD_DEVIATION 10.1 | 52.8 years STANDARD_DEVIATION 12.2 | 53.0 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 56 participants | 54 participants | 110 participants |
| Sex: Female, Male Female | 19 Participants | 24 Participants | 43 Participants |
| Sex: Female, Male Male | 37 Participants | 30 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 56 |
| other Total, other adverse events | 39 / 54 | 20 / 56 |
| serious Total, serious adverse events | 21 / 54 | 7 / 56 |
Outcome results
Primary
Fugl-Meyer Motor Assessment (FMA)
Lower limb motor impairment as measured by the lower limb portion of the Fugl-Meyer Assessment (FMA) which consists of 17 items, with a maximum possible score of 34 points, with lower scores indicating higher impairment. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform).
Time frame: Weeks 0, 12, 24, 36
Population: For intent-to-treat analysis, all participants who were randomized and completed baseline assessments were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peroneal Nerve Stimulation | Fugl-Meyer Motor Assessment (FMA) | Baseline | 20.1 units on a scale | Standard Deviation 5.9 |
| Peroneal Nerve Stimulation | Fugl-Meyer Motor Assessment (FMA) | 24- weeks | 21.26 units on a scale | Standard Deviation 6.05 |
| Peroneal Nerve Stimulation | Fugl-Meyer Motor Assessment (FMA) | 12- weeks | 21.5 units on a scale | Standard Deviation 6.27 |
| Peroneal Nerve Stimulation | Fugl-Meyer Motor Assessment (FMA) | 36 weeks | 21.93 units on a scale | Standard Deviation 5.84 |
| Standard of Care | Fugl-Meyer Motor Assessment (FMA) | 36 weeks | 21.02 units on a scale | Standard Deviation 5.69 |
| Standard of Care | Fugl-Meyer Motor Assessment (FMA) | Baseline | 20.3 units on a scale | Standard Deviation 6 |
| Standard of Care | Fugl-Meyer Motor Assessment (FMA) | 12- weeks | 21.18 units on a scale | Standard Deviation 5.72 |
| Standard of Care | Fugl-Meyer Motor Assessment (FMA) | 24- weeks | 21.17 units on a scale | Standard Deviation 5.58 |
95% CI: [-0.2, 2.75]
Secondary
Gait Speed
Time frame: baseline, 12, 24 and 36 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peroneal Nerve Stimulation | Gait Speed | 12-weeks | 0.40 meters/sec | Standard Deviation 0.25 |
| Peroneal Nerve Stimulation | Gait Speed | Baseline | 0.35 meters/sec | Standard Deviation 0.2 |
| Peroneal Nerve Stimulation | Gait Speed | 24-weeks | 0.44 meters/sec | Standard Deviation 0.28 |
| Peroneal Nerve Stimulation | Gait Speed | 36-weeks | 0.44 meters/sec | Standard Deviation 0.28 |
| Standard of Care | Gait Speed | 36-weeks | 0.47 meters/sec | Standard Deviation 0.24 |
| Standard of Care | Gait Speed | 24-weeks | 0.46 meters/sec | Standard Deviation 0.25 |
| Standard of Care | Gait Speed | Baseline | 0.40 meters/sec | Standard Deviation 0.24 |
| Standard of Care | Gait Speed | 12-weeks | 0.47 meters/sec | Standard Deviation 0.24 |
p-value: <0.0595% CI: [-0.045, 0.057]Mixed Models Analysis
Secondary
Modified Emory Functional Ambulation Profile(mEFAP)
The mEFAP comprises 5 individually timed tasks performed over different environmental terrains. The subtasks include (1) a 5-meter walk on a hard floor; (2) a 5-meter walk on a carpeted surface; (3) rising from a chair, a 3-meter walk, and return to a seated position (the timed up-and-go test); (4) traversing a standardized obstacle course; and (5) ascending and descending 5 stairs. The mEFAP is performed with or without the use of an orthotic device or an AD. Manual assistance (MA) is provided as necessary. The subject can use rails when climbing the stairs. The 5 timed subscores are added to derive a total score in seconds.
Time frame: Weeks 0, 12, 24, 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peroneal Nerve Stimulation | Modified Emory Functional Ambulation Profile(mEFAP) | Baseline | 121.54 seconds | Standard Deviation 86.59 |
| Peroneal Nerve Stimulation | Modified Emory Functional Ambulation Profile(mEFAP) | 12- weeks | 107.92 seconds | Standard Deviation 78.8 |
| Peroneal Nerve Stimulation | Modified Emory Functional Ambulation Profile(mEFAP) | 24-weeks | 110.81 seconds | Standard Deviation 81.89 |
| Peroneal Nerve Stimulation | Modified Emory Functional Ambulation Profile(mEFAP) | 36-weeks | 111.81 seconds | Standard Deviation 83.16 |
| Standard of Care | Modified Emory Functional Ambulation Profile(mEFAP) | 36-weeks | 96.20 seconds | Standard Deviation 65.2 |
| Standard of Care | Modified Emory Functional Ambulation Profile(mEFAP) | Baseline | 118.39 seconds | Standard Deviation 74.1 |
| Standard of Care | Modified Emory Functional Ambulation Profile(mEFAP) | 24-weeks | 97.25 seconds | Standard Deviation 71.4 |
| Standard of Care | Modified Emory Functional Ambulation Profile(mEFAP) | 12- weeks | 93.47 seconds | Standard Deviation 73.02 |
p-value: <0.0595% CI: [-14.096, 14.716]Mixed Models Analysis
Secondary
Steps Per Minute
The number of steps taken by participants in one minute
Time frame: Weeks 0, 12, 24, 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peroneal Nerve Stimulation | Steps Per Minute | Baseline | 65.0 Steps/Min | Standard Deviation 22 |
| Peroneal Nerve Stimulation | Steps Per Minute | 12-weeks | 67.4 Steps/Min | Standard Deviation 21.5 |
| Peroneal Nerve Stimulation | Steps Per Minute | 24-weeks | 69.3 Steps/Min | Standard Deviation 26.35 |
| Peroneal Nerve Stimulation | Steps Per Minute | 36-weeks | 70.84 Steps/Min | Standard Deviation 26.83 |
| Standard of Care | Steps Per Minute | 36-weeks | 73.74 Steps/Min | Standard Deviation 22.73 |
| Standard of Care | Steps Per Minute | Baseline | 66.7 Steps/Min | Standard Deviation 22.7 |
| Standard of Care | Steps Per Minute | 24-weeks | 72.0 Steps/Min | Standard Deviation 23.16 |
| Standard of Care | Steps Per Minute | 12-weeks | 72.6 Steps/Min | Standard Deviation 22.6 |
p-value: <0.0595% CI: [-10.05, -0.09]Mixed Models Analysis
Secondary
Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains: Mobility, Energy, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, Personality. There are 11 subscales. Items are rated on a 5-point Likert scale with higher scores indicate better functioning. The overall SS-QOL summary score (summation of all items) is presented here. Scores range from 49-245.
Time frame: Weeks 0, 12, 24, 36
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peroneal Nerve Stimulation | Stroke-Specific Quality of Life Scale (SS-QOL) | 12-weeks | 191.62 Summary Score | Standard Deviation 42.39 |
| Peroneal Nerve Stimulation | Stroke-Specific Quality of Life Scale (SS-QOL) | Baseline | 179.12 Summary Score | Standard Deviation 35.73 |
| Peroneal Nerve Stimulation | Stroke-Specific Quality of Life Scale (SS-QOL) | 24-weeks | 195.66 Summary Score | Standard Deviation 38.25 |
| Peroneal Nerve Stimulation | Stroke-Specific Quality of Life Scale (SS-QOL) | 36-weeks | 190.23 Summary Score | Standard Deviation 44.73 |
| Standard of Care | Stroke-Specific Quality of Life Scale (SS-QOL) | 36-weeks | 182.95 Summary Score | Standard Deviation 39.76 |
| Standard of Care | Stroke-Specific Quality of Life Scale (SS-QOL) | 12-weeks | 185.42 Summary Score | Standard Deviation 34.76 |
| Standard of Care | Stroke-Specific Quality of Life Scale (SS-QOL) | 24-weeks | 184.87 Summary Score | Standard Deviation 38.88 |
| Standard of Care | Stroke-Specific Quality of Life Scale (SS-QOL) | Baseline | 175.30 Summary Score | Standard Deviation 40.67 |
95% CI: [-12.79, 8.89]