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To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop. The comparison will involve physical measurements (e.g. walking speed, physiological cost index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and acceptance of the technology by stroke survivors.
Stroke is the third leading cause of death in the United States and other developed countries and a major source of disability, often leading to hospitalization. Prognosis for regaining the ability to walk is good, with 64% of those initially dependent in walking regaining independence by three months. However, many gait abnormalities persist.
Reduced hip, knee and ankle excursions during swing are among the persistent gait abnormalities contributing to poor or inefficient limb clearance. This is generally referred to as "foot drop", since the foot drops or drags along the ground during the swing phase. Swing phase abnormalities can result in decreased velocity, limited endurance and an increased risk for falls. These factors can limit mobility and independence in the community. Therefore, intervention is warranted.
The conventional approach to address the poor swing limb function, specifically, insufficient ankle dorsiflexion, is the prescription of an ankle-foot orthosis (AFO). An AFO commonly limits ankle plantarflexion to enhance limb clearance during swing. An alternative approach is to stimulate the ankle dorsiflexors electrically during swing phase to reproduce motion, which can no longer be performed volitionally.
The WalkAide is a new foot drop stimulator. This small, self-contained device attaches to the leg below the knee. The WalkAide contains a number of patented features, including a tilt sensor that measures the orientation of the leg with respect to the vertical. When the leg is tilted back at the end of stance, stimulation of the common peroneal nerve is initiated. This produces flexion of the ankle and other joints (if a flexion reflex is elicited) so that the leg can clear the ground during swing. When the leg is tilted forward at the end of swing phase, the stimulus is terminated. The electrodes attach to the inside of a cuff that is molded to the leg for reproducible positioning from day to day. The device is also designed so that all operations can be done with a single hand, since hemiparesis may prevent the subject from using the other hand. Because of its enhanced features, the WalkAide is anticipated to increase walking speed and improve the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WalkAide | Experimental | Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks |
|
| Ankle Foot Orthosis | Active Comparator | Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks |
|
| No Crossover | Other | Subjects wear AFO for entire 12 weeks with no crossover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WalkAide | Device | Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Figure 8 Walking Speed Before and After Intervention. | Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks | baseline, 6, 6.2 and 12 weeks |
| Physiological Cost Index Before and After Intervention. | PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks | baseline, 6, 6.2 and 12 weeks |
| 10 Meter Walking Speed Before and After Intervention. | Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks | baseline, 6, 6.2 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO | Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Munin, MD | University of Pittsburgh, Department of PM&R | Principal Investigator |
| Sunil Hegde, MD | Huntington Rehabilitation Medicine Associates | Principal Investigator |
| Gerard Francisco, MD | Texas Institute of Rehabilitation Research | Principal Investigator |
| Richard Herman, MD | Good Samaritan Rehabilitation Institute | Principal Investigator |
| Thy Huskey, MD | Washington University in St. Louis, Department of Neurology | Principal Investigator |
| Gary Abrams, MD | University of California; San Francisco VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | United States | ||
| San Francisco VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23558080 | Result | Everaert DG, Stein RB, Abrams GM, Dromerick AW, Francisco GE, Hafner BJ, Huskey TN, Munin MC, Nolan KJ, Kufta CV. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):579-91. doi: 10.1177/1545968313481278. Epub 2013 Apr 4. |
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Recruitment took place between May 2005 and December 2008 at 9 Rehabilitation centers in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: WalkAide | Subjects started with the WalkAide and crossed over to the AFO after six weeks. |
| FG001 | Arm 2: Ankle Foot Orthosis | Subjects started with the AFO and crossed over to the WalkAide after six weeks. |
| FG002 | Arm 3: No Crossover | Subjects completed the entire 12 weeks period with the AFO, no crossover occurred. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 (Weeks 0 - 6) |
| |||||||||||||
| Phase 2 (Weeks 6 -12) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: WalkAide | Subjects started with the WalkAide and crossed over to the AFO after six weeks. |
| BG001 | Arm 2: Ankle Foot Orthosis | Subjects started with the AFO and crossed over to the WalkAide after six weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO | Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference | per protocol (completers) analysis | Posted | Number | participants | 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart surgery | Cardiac disorders | Systematic Assessment | Had emergency heart surgery 9/15/06 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation electrodes | Skin and subcutaneous tissue disorders | Systematic Assessment | Irritation from electrodes used with WalkAide |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Innovative Neurotronics | 512-721-1922 | hrogers@ininc.us |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| AFO | Device | Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks |
|
| AFO | Device | Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover |
|
| San Francisco |
| California |
| 94121 |
| United States |
| Washington University | St Louis | Missouri | 63108 | United States |
| University of Pittsburgh, Department of PM&R | Pittsburgh | Pennsylvania | 15213 | United States |
| Texas Institute of Rehabilitation Research | Houston | Texas | 77030 | United States |
| NOT COMPLETED |
|
| BG002 | Arm 3: No Crossover | Subjects completed the entire 12 weeks period with the AFO, no crossover occurred. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Chronicity | Chronicity refers to the number of years since onset of stroke | Mean | Standard Deviation | years |
|
| Participants |
|
|
|
| Primary | Figure 8 Walking Speed Before and After Intervention. | Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks | Posted | Mean | Standard Deviation | meters/second | baseline, 6, 6.2 and 12 weeks |
|
|
|
| Primary | Physiological Cost Index Before and After Intervention. | PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks | Posted | Mean | Standard Deviation | beats/minute | baseline, 6, 6.2 and 12 weeks |
|
|
|
| Primary | 10 Meter Walking Speed Before and After Intervention. | Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks | Posted | Mean | Standard Deviation | meters/second | baseline, 6, 6.2 and 12 weeks |
|
|
|
| 1 |
| 43 |
| 7 |
| 43 |
| EG001 | Arm 2 | All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks. | 1 | 39 | 5 | 39 |
| EG002 | Arm 3 | All subjects used AFO for all 12 weeks of study. | 1 | 30 | 1 | 30 |
|
| Death | Cardiac disorders | Systematic Assessment | began experiencing symptoms, went to ER and was admitted for an acute MI. Patient was discharged from the hospital and scheduled for heart surgery to remove blockage. However he then passed away suddenly, before the surgery was done |
|
| Wrist Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pt fell and fractured wrist. Subject was in teh AFO phase of Arm @ but was not wearing a study device at the time |
|
|
| Skin irritation AFO | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment | tripped and fell |
|
| Ankle sprain | Injury, poisoning and procedural complications | Systematic Assessment | sprained ankle getting out of bed |
|
| Sinus condition | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | subject missed visit due to sinus infection |
|
| Lost consciousness | General disorders | Systematic Assessment | Pt lost consciousness in Physical Therapy, no reason was reported |
|
| weakness and fatigue | General disorders | Systematic Assessment | Subject was weak and fatigued, required bedrest |
|
| LE swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject complained of swelling not previously noted |
|
| Shoulder surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject had surgery for rotator cuff tear |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| Week 0 on condition |
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| Week 6 on condition |
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| Week 6.2 off condition |
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| Week 12 off condition |
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| Week 6.2 on condition |
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| Week 12 on condition |
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| Week 0 on condition |
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| Week 6 on condition |
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| Week 6.2 off condition |
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| Week 12 off condition |
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| Week 6.2 on condition |
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| Week 12 on condition |
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| Week 0 on condition |
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| Week 6 on condition |
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| Week 6.2 off condition |
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| Week 12 off condition |
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| Week 6.2 on condition |
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| Week 12 on condition |
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