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

Completed · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT01087957

Run by

Innovative Neurotronics

People needed

495

Starts

2010-03-01

Expected to finish

2013-06-01

Last updated by the study team

2014-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Loma Linda University Medical Center — Loma Linda, California, United States
• The Los Angeles VA — Los Angeles, California, United States
• Casa Colina Centers for Rehabilitation — Pomona, California, United States
• The San Francisco VA Medical Center — San Francisco, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Halifax Hospital — Daytona Beach, Florida, United States
• Florida Hospital NORI — Orlando, Florida, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Marianjoy Rehabilitation — Wheaton, Illinois, United States
• Cardinal Hill Rehabilitation — Lexington, Kentucky, United States
• St. Mary's of Michigan — Saginaw, Michigan, United States
• University of Minnesota Twin-Cities — Minneapolis, Minnesota, United States
• Madonna Rehabilitation Hospital — Lincoln, Nebraska, United States
• Kessler Foundation Research Center — West Orange, New Jersey, United States
• United Healthcare — Johnson City, New York, United States
• South Shore Neurologic Associates — Patchogue, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Health Research Inc./Helen Hayes Hospital — West Haverstraw, New York, United States
• Guilford Neurologic Associates — Greensboro, North Carolina, United States
• FirstHealth of the Carolinas — Pinehurst, North Carolina, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Magee Rehabilitation Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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