Efficacy of the WalkAide and AFOs for CVA

Completed · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00216320

Run by

Innovative Neurotronics

People needed

121

Starts

2005-09-01

Expected to finish

2008-11-01

Last updated by the study team

2013-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• Washington University — St Louis, Missouri, United States
• University of Pittsburgh, Department of PM&R — Pittsburgh, Pennsylvania, United States
• Texas Institute of Rehabilitation Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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