At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Stroke (CVA) diagnosed within the last 365 days
- ✓Inadequate dorsiflexion during swing phase of gait with inadequate limb clearance
- ✓Medically stable for ≥6 months prior to most recent stroke
- ✕Lower motor neuron injury with inadequate response to stimulation
- ✕History of falls >1 per week prior to CVA
- ✕Severe cardiac disease (MI, CHF, demand pacemaker, or other electrical stimulator)
- ✕Fixed ankle contractures ≥5° plantarflexion with knee extended
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Three-Arm, Randomized Crossover Study Comparing the Innovative Neurotronics WalkAide™ System to Ankle-Foot Orthosis [AFO]
In Brief
A clinical study evaluating WalkAide and AFO for Stroke. Completed, enrolled 121 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover