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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.