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Efficacy of the WalkAide and AFOs for CVA

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ClinicalTrials.gov Identifier: NCT00216320
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics

Tracking Information
First Submitted Date  ICMJE September 19, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE April 18, 2013
Results First Posted Date  ICMJE April 19, 2013
Last Update Posted Date April 19, 2013
Study Start Date  ICMJE September 2005
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
  • Figure 8 Walking Speed Before and After Intervention. [ Time Frame: baseline, 6, 6.2 and 12 weeks ]
    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
  • Physiological Cost Index Before and After Intervention. [ Time Frame: baseline, 6, 6.2 and 12 weeks ]
    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
  • 10 Meter Walking Speed Before and After Intervention. [ Time Frame: baseline, 6, 6.2 and 12 weeks ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
  • Use of a foot drop stimulator will significantly increase the speed of walking compared to each subjects preferred method of walking without stimulation.
  • Use of a foot drop stimulator will decrease the physiological cost index (PCI) compared to each subject's preferred method of walking without stimulation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO [ Time Frame: 12 weeks ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2005)
Subjects wills score higher on a variety of functional walking and quality of life tests while using the WalkAide.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of the WalkAide and AFOs for CVA
Official Title  ICMJE A Three-Arm, Randomized Crossover Study Comparing the Innovative Neurotronics WalkAide™ System to Ankle-Foot Orthosis [AFO]
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Device: WalkAide
    Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
  • Device: AFO
    Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
  • Device: AFO
    Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover
Study Arms  ICMJE
  • Experimental: WalkAide
    Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
    Interventions:
    • Device: WalkAide
    • Device: AFO
  • Active Comparator: Ankle Foot Orthosis
    Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
    Interventions:
    • Device: WalkAide
    • Device: AFO
  • No Crossover
    Subjects wear AFO for entire 12 weeks with no crossover
    Intervention: Device: AFO
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2013)
121
Original Enrollment  ICMJE
 (submitted: September 19, 2005)
75
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults aged 18 years or older
  2. Diagnosed with cerebrovascular accident (CVA) within the last 365 days
  3. Inadequate dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
  4. Medically stable for six months prior to the most recent episode of stroke resulting in hemiplegia or hemiparesis with foot drop
  5. Medical clearance by the attending physician to participate in the study
  6. Expectation that current medication can be maintained without drastic change for at least six months
  7. Adequate stability at the ankle during stance (with stimulation)
  8. Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device and give adequate feedback
  9. Ability to ambulate with or without an assistive device (or assistance) at least 10 meters

Exclusion Criteria:

  1. Lower motor neuron injury with inadequate response to stimulation
  2. History of falls greater than once a week prior to the CVA
  3. Severe cardiac disease such as myocardial infarction, congestive heart failure or a demand pacemaker (or other electrical stimulator)
  4. Fixed ankle contractures of five degrees of plantarflexion with knee extended
  5. Moderate to normal ambulation velocity (greater than 1.2 m/s)
  6. Unable to operate the device safely by self and caregiver assistance not available
  7. Need for an AFO for stance control of the foot, ankle and/or knee
  8. Comorbid conditions unlikely to survive one year
  9. Pre-existing history of seizure disorder prior to most recent episode of CVA
  10. Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
  11. Morbid obesity that limits the subject's response to stimulation due to adipose tissue [BMI > 40]
  12. Excessive dysesthetic pain secondary to neurological involvement
  13. Severe hypertonicity resulting in the need for more involved orthotic strategies or pharmacological interventions (e.g. Botox)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00216320
Other Study ID Numbers  ICMJE WalkAide Trials
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innovative Neurotronics
Study Sponsor  ICMJE Innovative Neurotronics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Innovative Neurotronics
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP