Efficacy of the WalkAide and AFOs for CVA (NCT00216320) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the WalkAide and AFOs for CVA
United States121 participantsStarted 2005-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Figure 8 Walking Speed Before and After Intervention.
Timeframe: baseline, 6, 6.2 and 12 weeks
2
Physiological Cost Index Before and After Intervention.
Timeframe: baseline, 6, 6.2 and 12 weeks
3
10 Meter Walking Speed Before and After Intervention.