StrokeNCT01087957
WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
A study testing WalkAide and Ankle-Foot Orthosis (AFO) in people with Stroke, run by Innovative Neurotronics at 29 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- WalkAide and Ankle-Foot Orthosis (AFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 29 sitesUnited States
- Study dates
- Mar 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
St. David's Rehabilitation Hospital
Austin, Texas, 78705
Medical University of South Carolina
Charleston, South Carolina, 29425
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
The Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Medical Center
Columbus, Ohio, 43210
The Dallas VA
Dallas, Texas, 75216
Halifax Hospital
Daytona Beach, Florida, 32114
Guilford Neurologic Associates
Greensboro, North Carolina, 27405
Hartford Hospital
Hartford, Connecticut, 06102
United Healthcare
Johnson City, New York, 13790
Cardinal Hill Rehabilitation
Lexington, Kentucky, 55404
Madonna Rehabilitation Hospital
Lincoln, Nebraska, 68506
The Loma Linda University Medical Center
Loma Linda, California, 92534
The Los Angeles VA
Los Angeles, California, 90073
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
University of Minnesota Twin-Cities
Minneapolis, Minnesota, 55454
Florida Hospital NORI
Orlando, Florida, 32804
South Shore Neurologic Associates
Patchogue, New York, 11772
Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, 19102
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374
Casa Colina Centers for Rehabilitation
Pomona, California, 91769
Oregon Health & Science University
Portland, Oregon, 97239
St. Mary's of Michigan
Saginaw, Michigan, 48604
The San Francisco VA Medical Center
San Francisco, California, 94121
SUNY Upstate Medical University
Syracuse, New York, 13210
Health Research Inc./Helen Hayes Hospital
West Haverstraw, New York, 10993
Kessler Foundation Research Center
West Orange, New Jersey, 07052
Marianjoy Rehabilitation
Wheaton, Illinois, 60187
About this study
Official title: Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)
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.
Read the detailed description
This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).
- Conditions
- Stroke
- Being tested
- WalkAide, Ankle-Foot Orthosis (AFO)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkAideDevice
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Ankle-Foot Orthosis (AFO)Other
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
| Study group | Role | What they receive |
|---|---|---|
| Ankle-Foot Orthosis (AFO) | Active comparator | Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Receives: Other: Ankle-Foot Orthosis (AFO) |
| WalkAide | Active comparator | Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Receives: Device: WalkAide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity
Improved ambulation status, specific to increase in gait velocity (m/s)
Measured: 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.
Measured: 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).
Measured: 6 months
Secondary outcomes (8)
Six Minute Walk Test
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Neurotronics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Bethoux, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087957
- Sponsor's protocol ID
- INSTRIDE
- Status last verified
- Apr 2014
- First submitted
- 15 Mar 2010
- Last updated
- 13 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy TM, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2014 Sep;28(7):688-97. doi: 10.1177/1545968314521007. Epub 2014 Feb 13.
PubMed 24526708Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy T, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):911-22. doi: 10.1177/1545968315570325. Epub 2015 Feb 4.
PubMed 25653225
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)
- ClinicalTrials.gov ID
- NCT01087957
- Acronym / sponsor ID
- INSTRIDE
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Innovative NeurotronicsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Posted 13 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle-Foot Orthosis (AFO) | Active comparator | Other: Ankle-Foot Orthosis (AFO)Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) |
| WalkAide | Active comparator | Device: WalkAideComparison of WalkAide device against Ankle-Foot Orthosis (AFO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkAideComparison of WalkAide device against Ankle-Foot Orthosis (AFO) | Device | WalkAide |
| Ankle-Foot Orthosis (AFO)Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) | Other | Ankle-Foot Orthosis (AFO) |
Primary outcome
Gait Velocity
Time frame: 6 months
Improved ambulation status, specific to increase in gait velocity (m/s)
Stroke Impact Scale (SIS) Composite Score
Time frame: 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
Time frame: 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).
8 secondary outcomes
Six Minute Walk Test
Time frame: 6 months
Modified Emory Functional Ambulation Profile Total Score
Time frame: 6 months
Modified Emory Functional Ambulation Profile Floor Time
Time frame: 6 months
Modified Emory Functional Ambulation Profile Carpet Time
Time frame: 6 months
Modified Emory Functional Ambulation Profile Timed up and Go
Time frame: 6 months
Modified Emory Functional Ambulation Profile Obstacle Course
Time frame: 6 months
Modified Emory Functional Ambulation Profile Stair Time
Time frame: 6 months
Berg Balance Scale
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24526708Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy TM, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial. Neurorehabil Neural Repair. 2014 Sep;28(7):688-97. doi: 10.1177/1545968314521007. Epub 2014 Feb 13.
- Derived from this study: PubMed 25653225Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy T, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):911-22. doi: 10.1177/1545968315570325. Epub 2015 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Bethoux, M.D. principal investigator
The Cleveland Clinic
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WalkAide and Ankle-Foot Orthosis (AFO) in people with Stroke, run by Innovative Neurotronics at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087957, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.