Efficacy of the WalkAide and AFOs for CVA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics
ClinicalTrials.gov Identifier:
NCT00216320
First received: September 19, 2005
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Stroke
Device: WalkAide
Device: AFO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Three-Arm, Randomized Crossover Study Comparing the Innovative Neurotronics WalkAide™ System to Ankle-Foot Orthosis [AFO]

Resource links provided by NLM:


Further study details as provided by Innovative Neurotronics:

Primary Outcome Measures:
  • Figure 8 Walking Speed Before and After Intervention. [ Time Frame: baseline, 6, 6.2 and 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 121
Study Start Date: September 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WalkAide
Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
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
Active Comparator: Ankle Foot Orthosis
Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
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
No Crossover
Subjects wear AFO for entire 12 weeks with no crossover
Device: AFO
Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216320

Locations
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63108
United States, Pennsylvania
University of Pittsburgh, Department of PM&R
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Texas Institute of Rehabilitation Research
Houston, Texas, United States, 77030
Sponsors and Collaborators
Innovative Neurotronics
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
  More Information

Publications:
Responsible Party: Innovative Neurotronics
ClinicalTrials.gov Identifier: NCT00216320     History of Changes
Other Study ID Numbers: WalkAide Trials
Study First Received: September 19, 2005
Results First Received: April 18, 2013
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Innovative Neurotronics:
electrical stimulation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014