WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

Study Overview
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Brief Summary
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To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.

Detailed Description
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This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).

Official Title
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Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)

Conditions
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Stroke

Intervention / Treatment
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* Device: WalkAide
* Other: Ankle-Foot Orthosis (AFO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient history of stroke (ischemic and/or hemorrhagic). Patient is at least 6 months post stroke. Patient has hemiplegia/hemiparesis. Patient has inadequate dorsiflexion during swing phase of gait, resulting in inadequate limb clearance. Patient is not currently using Functional Electrical Stimulation for the treatment of footdrop. Patient is a minimum of 30 days post inpatient or outpatient stroke, cardiac, pulmonary, or physical rehabilitation on the lower extremity. Patient is a minimum of 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement). Patient is a minimum of 90 days post myocardial infarction. Patient is a minimum of 90 days post stenting procedure (i.e. peripheral, cardiac, carotid, and/or renal). Patient is a minimum of 6 months post CABG or cardiac valve procedure. Patient is able to walk at least 10 meters with or without an assist device (excluding an AFO or WalkAide device). Patient has an initial gait speed > 0.0 m/s and < 0.8 m/s. Patient has a positive response to peroneal nerve stimulation testing, resulting adequate dorsiflexion of the ankle. Patient has adequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score >17 within 30 days prior to enrollment. Patient has completed a full neurological assessment within 30 days prior to enrollment. Patient is eligible for Medicare or Medicare Choice/Advantage benefits at the time of enrollment Patient is able and willing to comply with study procedures, including follow-up requirements. Patient is able and willing to give written informed consent. Exclusion Criteria Patient is less than 6-months post stroke. Patient has inadequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score < 17 within 30 days prior to enrollment. Patient has ankle joint instability other than foot drop. Patient is less than 30 days post inpatient or outpatient: stroke, cardiac, pulmonary, or any type of physical rehabilitation on the lower extremity at time of enrollment. Patient has need for an AFO for stance control of the foot, ankle and/or knee. Patient has an initial gait speed of 0.8 m/s or greater classified as a full community walker (independent in all home and community activities). Patient is not able to safely clear toes in swing phase on the involved lower extremity, defined as >-5° plantar flexion, with the device determined at fitting visit. Patient has been diagnosed with peripheral neuropathy and symptoms obstruct or limit ambulation or participation in study procedures. Patient has been diagnosed with significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication. Patient has underlying condition(s) that would limit study participation such as severe hypertonicity resulting in the need for more involved orthotic strategies or excessive dysesthetic pain secondary to neurological involvement. Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Patient is NYHA Class III or IV. Patient has malignant skin lesion below the knee on the affected lower extremity. Patient has history of seizure disorder and on seizure medications. Patient has aphasia, defined as incapacity to verbalize commands. Patient has Beck Depression Index score of > 29 indicating severe depression. Patient has a life expectancy less than 12 months. Patient has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation, TENS). Patient is less than 6 months free from Botulinum Toxin (Botox) injection in the lower extremity. Patient has baclofen pump with unstable dosing in the last 3 months. Patient is unable or unwilling to comply with study procedures, including follow-up requirements. Patient is participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results. Patient is unable or unwilling to give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ankle-Foot Orthosis (AFO)<br>Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) | Other: Ankle-Foot Orthosis (AFO)<br>* Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)<br>|
| Active Comparator: WalkAide<br>Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) | Device: WalkAide<br>* Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Velocity | Improved ambulation status, specific to increase in gait velocity (m/s) | 6 months | 
| Stroke Impact Scale (SIS) Composite Score | The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40. | 6 months | 
| Device Related Serious Adverse Events | The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test |  | 6 months | 
| Modified Emory Functional Ambulation Profile Total Score | The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask. | 6 months | 
| Modified Emory Functional Ambulation Profile Floor Time | The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score. | 6 months | 
| Modified Emory Functional Ambulation Profile Carpet Time | The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score . | 6 months | 
| Modified Emory Functional Ambulation Profile Timed up and Go | The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score. | 6 months | 
| Modified Emory Functional Ambulation Profile Obstacle Course | The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score. | 6 months | 
| Modified Emory Functional Ambulation Profile Stair Time | The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score . | 6 months | 
| Berg Balance Scale | The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. | 6 months |