Efficacy of the WalkAide and AFOs for CVA
A Three-Arm, Randomized Crossover Study Comparing the Innovative Neurotronics WalkAide™ System to Ankle-Foot Orthosis [AFO]
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner Good Samaritan Medical Center
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California
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San Francisco, California, United States, 94121
- San Francisco VA Medical Center
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Missouri
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St. Louis, Missouri, United States, 63108
- Washington University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh, Department of PM&R
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Texas
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Houston, Texas, United States, 77030
- Texas Institute of Rehabilitation Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Diagnosed with cerebrovascular accident (CVA) within the last 365 days
- Inadequate dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
- Medically stable for six months prior to the most recent episode of stroke resulting in hemiplegia or hemiparesis with foot drop
- Medical clearance by the attending physician to participate in the study
- Expectation that current medication can be maintained without drastic change for at least six months
- Adequate stability at the ankle during stance (with stimulation)
- Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device and give adequate feedback
- Ability to ambulate with or without an assistive device (or assistance) at least 10 meters
Exclusion Criteria:
- Lower motor neuron injury with inadequate response to stimulation
- History of falls greater than once a week prior to the CVA
- Severe cardiac disease such as myocardial infarction, congestive heart failure or a demand pacemaker (or other electrical stimulator)
- Fixed ankle contractures of five degrees of plantarflexion with knee extended
- Moderate to normal ambulation velocity (greater than 1.2 m/s)
- Unable to operate the device safely by self and caregiver assistance not available
- Need for an AFO for stance control of the foot, ankle and/or knee
- Comorbid conditions unlikely to survive one year
- Pre-existing history of seizure disorder prior to most recent episode of CVA
- Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
- Morbid obesity that limits the subject's response to stimulation due to adipose tissue [BMI > 40]
- Excessive dysesthetic pain secondary to neurological involvement
- Severe hypertonicity resulting in the need for more involved orthotic strategies or pharmacological interventions (e.g. Botox)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: WalkAide
Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
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Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover
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|
Active Comparator: Ankle Foot Orthosis
Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
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Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover
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Other: No Crossover
Subjects wear AFO for entire 12 weeks with no crossover
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Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Figure 8 Walking Speed Before and After Intervention.
Time Frame: baseline, 6, 6.2 and 12 weeks
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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
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baseline, 6, 6.2 and 12 weeks
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Physiological Cost Index Before and After Intervention.
Time Frame: baseline, 6, 6.2 and 12 weeks
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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
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baseline, 6, 6.2 and 12 weeks
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10 Meter Walking Speed Before and After Intervention.
Time Frame: baseline, 6, 6.2 and 12 weeks
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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
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baseline, 6, 6.2 and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO
Time Frame: 12 weeks
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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
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WalkAide Trials
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