Efficacy of the WalkAide and AFOs for CVA

Completed

Phase N/A Results

Eligibility 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)