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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Ankle-Foot Orthosis (AFO); Device: WalkAide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 495
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92534
      • The Loma Linda University Medical Center
    • Los Angeles, California, United States, 90073
      • The Los Angeles VA
    • Pomona, California, United States, 91769
      • Casa Colina Centers for Rehabilitation
    • San Francisco, California, United States, 94121
      • The San Francisco VA Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Halifax Hospital
    • Orlando, Florida, United States, 32804
      • Florida Hospital NORI
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60611
      • Rehabilitation Institute of Chicago
    • Wheaton, Illinois, United States, 60187
      • Marianjoy Rehabilitation
  • Kentucky
    • Lexington, Kentucky, United States, 55404
      • Cardinal Hill Rehabilitation
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • St. Mary's of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Twin-Cities
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Madonna Rehabilitation Hospital
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation Research Center
  • New York
    • Johnson City, New York, United States, 13790
      • United Healthcare
    • Patchogue, New York, United States, 11772
      • South Shore Neurologic Associates
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
    • West Haverstraw, New York, United States, 10993
      • Health Research Inc./Helen Hayes Hospital
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Guilford Neurologic Associates
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth of the Carolinas
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Magee Rehabilitation Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78705
      • St. David's Rehabilitation Hospital
    • Dallas, Texas, United States, 75216
      • The Dallas VA
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ankle-Foot Orthosis (AFO); Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	Other: Ankle-Foot Orthosis (AFO); Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Active Comparator: WalkAide; Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)	Device: WalkAide; Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Innovative Neurotronics
• Investigators: Principal Investigator: Francois Bethoux, M.D., The Cleveland Clinic

Publications and helpful links

General 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.
• Bethoux 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimate): March 16, 2010

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: INSTRIDE