N/A
N=112
Efficacy of the WalkAide and AFOs for CVA
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00216320 ↗Enrolled (actual)
112
Serious AEs
2.7%
Results posted
Apr 2013
Primary outcome: Primary: Figure 8 Walking Speed Before and After Intervention. — .337; .312; .261; .432 meters/second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WalkAide (Device); AFO (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Innovative Neurotronics
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Figure 8 Walking Speed Before and After Intervention. |
.337; .312; .261; .432; .377; .303 | — |
| PRIMARY Physiological Cost Index Before and After Intervention. |
.957; 1.128; 1.486; .824; .978; 1.311 | — |
| PRIMARY 10 Meter Walking Speed Before and After Intervention. |
.457; .415; .361; .575; .489; .428 | — |
| SECONDARY Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO |
45 | <.001 sig |
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.
Eligibility Criteria
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
- Ability to ambulate with or without an assistive device (or assistance) at least 10 meters
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
- 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)
Data sourced from ClinicalTrials.gov (NCT00216320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.