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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics
ClinicalTrials.gov Identifier:
NCT01087957
First received: March 15, 2010
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Stroke
Device: WalkAide
Other: Ankle-Foot Orthosis (AFO)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)

Resource links provided by NLM:


Further study details as provided by Innovative Neurotronics:

Primary Outcome Measures:
  • Gait Velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improved ambulation status, specific to increase in gait velocity (m/s)

  • Stroke Impact Scale (SIS) Composite Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Six Minute Walk Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Modified Emory Functional Ambulation Profile Total Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Modified Emory Functional Ambulation Profile Carpet Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Modified Emory Functional Ambulation Profile Obstacle Course [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Stair Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 495
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087957

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

Publications:
Responsible Party: Innovative Neurotronics
ClinicalTrials.gov Identifier: NCT01087957     History of Changes
Other Study ID Numbers: INSTRIDE
Study First Received: March 15, 2010
Results First Received: February 25, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 19, 2014