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

NCT ID: NCT01087957

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-06-30

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).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Group Type: ACTIVE_COMPARATOR

Ankle-Foot Orthosis (AFO)

Intervention Type: OTHER

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

WalkAide

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Group Type: ACTIVE_COMPARATOR

WalkAide

Intervention Type: DEVICE

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Interventions

WalkAide

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Intervention Type: DEVICE

Ankle-Foot Orthosis (AFO)

Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Neurotronics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois Bethoux, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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

Medical University of South Carolina

Charleston, South Carolina, United States

St. David's Rehabilitation Hospital

Austin, Texas, United States

The Dallas VA

Dallas, Texas, United States

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24526708 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25653225 (View on PubMed)

Other Identifiers

INSTRIDE

Identifier Type: -

Identifier Source: org_study_id