Stroke
Conditions
Brief summary
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
This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).
Interventions
DEVICEWalkAide
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
OTHERAnkle-Foot Orthosis (AFO)
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Sponsors
Innovative Neurotronics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | 6 months | Improved ambulation status, specific to increase in gait velocity (m/s) |
| Stroke Impact Scale (SIS) Composite Score | 6 months | 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. |
| Device Related Serious Adverse Events | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Emory Functional Ambulation Profile Carpet Time | 6 months | 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 . |
| Modified Emory Functional Ambulation Profile Timed up and Go | 6 months | 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. |
| Six Minute Walk Test | 6 months | — |
| Modified Emory Functional Ambulation Profile Stair Time | 6 months | 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 . |
| Berg Balance Scale | 6 months | 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. |
| Modified Emory Functional Ambulation Profile Obstacle Course | 6 months | 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. |
| Modified Emory Functional Ambulation Profile Total Score | 6 months | 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. |
| Modified Emory Functional Ambulation Profile Floor Time | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ankle-Foot Orthosis (AFO) Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) | 253 |
| WalkAide Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) | 242 |
| Total | 495 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Physician Decision | 5 | 9 |
| Overall Study | Protocol Violation | 13 | 25 |
| Overall Study | Withdrawal by Subject | 18 | 15 |
Baseline characteristics
| Characteristic | WalkAide | Ankle-Foot Orthosis (AFO) | Total |
|---|---|---|---|
| Age, Continuous | 63.87 years STANDARD_DEVIATION 11.33 | 64.30 years STANDARD_DEVIATION 12.01 | 64.09 years STANDARD_DEVIATION 11.58 |
| Beck Depression Inventory | 7.98 units on a scale STANDARD_DEVIATION 6.32 | 8.08 units on a scale STANDARD_DEVIATION 6.58 | 8.05 units on a scale STANDARD_DEVIATION 6.45 |
| Body Mass Index | 27.98 kilograms/meters squared STANDARD_DEVIATION 4.93 | 29.21 kilograms/meters squared STANDARD_DEVIATION 5.08 | 28.61 kilograms/meters squared STANDARD_DEVIATION 5.04 |
| Initial Gait Speed | .449 meters/second STANDARD_DEVIATION 0.22 | .487 meters/second STANDARD_DEVIATION 0.21 | .47 meters/second STANDARD_DEVIATION 0.21 |
| Mini Mental Status Exam | 27.62 units on a scale STANDARD_DEVIATION 2.44 | 27.49 units on a scale STANDARD_DEVIATION 2.83 | 27.54 units on a scale STANDARD_DEVIATION 2.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants | 55 Participants | 110 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) White | 177 Participants | 187 Participants | 364 Participants |
| Sex: Female, Male Female | 95 Participants | 96 Participants | 191 Participants |
| Sex: Female, Male Male | 147 Participants | 157 Participants | 304 Participants |
| Time Post Onset of Stroke | 6.90 years STANDARD_DEVIATION 6.43 | 6.86 years STANDARD_DEVIATION 6.64 | 6.88 years STANDARD_DEVIATION 6.53 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 146 / 253 | 162 / 242 |
| serious Total, serious adverse events | 17 / 253 | 18 / 242 |
Outcome results
Primary
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).
Time frame: 6 months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankle-Foot Orthosis (AFO) | Device Related Serious Adverse Events | 2 number of device related SAEs |
| WalkAide | Device Related Serious Adverse Events | 0 number of device related SAEs |
Primary
Gait Velocity
Improved ambulation status, specific to increase in gait velocity (m/s)
Time frame: 6 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Gait Velocity | .682 m/sec | Standard Error 0.02 |
| WalkAide | Gait Velocity | .635 m/sec | Standard Error 0.022 |
Primary
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.
Time frame: 6 months
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Stroke Impact Scale (SIS) Composite Score | 172.7 points | Standard Error 2.8 |
| WalkAide | Stroke Impact Scale (SIS) Composite Score | 175.0 points | Standard Error 2.7 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Berg Balance Scale | 44.7 units on a scale | Standard Error 0.8 |
| WalkAide | Berg Balance Scale | 44.9 units on a scale | Standard Error 0.6 |
Secondary
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 .
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Modified Emory Functional Ambulation Profile Carpet Time | 56.1 seconds | Standard Error 6.6 |
| WalkAide | Modified Emory Functional Ambulation Profile Carpet Time | 57.1 seconds | Standard Error 4.4 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Modified Emory Functional Ambulation Profile Floor Time | 56.0 seconds | Standard Error 8 |
| WalkAide | Modified Emory Functional Ambulation Profile Floor Time | 52.5 seconds | Standard Error 3.9 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Modified Emory Functional Ambulation Profile Obstacle Course | 169.8 seconds | Standard Error 11.8 |
| WalkAide | Modified Emory Functional Ambulation Profile Obstacle Course | 182.2 seconds | Standard Error 14.8 |
Secondary
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 .
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Modified Emory Functional Ambulation Profile Stair Time | 66.4 seconds | Standard Error 5.3 |
| WalkAide | Modified Emory Functional Ambulation Profile Stair Time | 79.3 seconds | Standard Error 5.9 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Modified Emory Functional Ambulation Profile Timed up and Go | 131.0 seconds | Standard Error 14.7 |
| WalkAide | Modified Emory Functional Ambulation Profile Timed up and Go | 126.9 seconds | Standard Error 9.4 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Modified Emory Functional Ambulation Profile Total Score | 479.4 seconds | Standard Error 38.3 |
| WalkAide | Modified Emory Functional Ambulation Profile Total Score | 498.0 seconds | Standard Error 32 |
Secondary
Six Minute Walk Test
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle-Foot Orthosis (AFO) | Six Minute Walk Test | 218.6 meters | Standard Error 7.6 |
| WalkAide | Six Minute Walk Test | 209.2 meters | Standard Error 8.5 |