Status:
COMPLETED
Efficacy of the WalkAide and AFOs for CVA
Lead Sponsor:
Innovative Neurotronics
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 Riv...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00216320
Start Date
September 1 2005
End Date
November 1 2008
Last Update
April 19 2013
Active Locations (5)
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1
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121
3
Washington University
St Louis, Missouri, United States, 63108
4
University of Pittsburgh, Department of PM&R
Pittsburgh, Pennsylvania, United States, 15213