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

NCT01087957 | Completed Results DMC

• 1 other identifier: INSTRIDE
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 29

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Six Minute Walk Test

  6 months

• Modified Emory Functional Ambulation Profile Total Score

  6 months

• Modified Emory Functional Ambulation Profile Floor Time

  6 months

• Modified Emory Functional Ambulation Profile Carpet Time

  6 months

• Modified Emory Functional Ambulation Profile Timed up and Go

  6 months

Study Arms (2)

Ankle-Foot Orthosis (AFO)

ACTIVE COMPARATOR

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

Other: Ankle-Foot Orthosis (AFO)

WalkAide

ACTIVE COMPARATOR

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

Device: WalkAide

Interventions

WalkAide DEVICE

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

WalkAide

Ankle-Foot Orthosis (AFO) OTHER

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

Ankle-Foot Orthosis (AFO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Innovative Neurotronics: lead

Study Sites (29)

The Loma Linda University Medical Center

Loma Linda, California, 92534, United States

Location

The Los Angeles VA

Los Angeles, California, 90073, United States

Location

Casa Colina Centers for Rehabilitation

Pomona, California, 91769, United States

Location

The San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Halifax Hospital

Daytona Beach, Florida, 32114, United States

Location

Florida Hospital NORI

Orlando, Florida, 32804, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Marianjoy Rehabilitation

Wheaton, Illinois, 60187, United States

Location

Cardinal Hill Rehabilitation

Lexington, Kentucky, 55404, United States

Location

St. Mary's of Michigan

Saginaw, Michigan, 48604, United States

Location

University of Minnesota Twin-Cities

Minneapolis, Minnesota, 55454, United States

Location

Madonna Rehabilitation Hospital

Lincoln, Nebraska, 68506, United States

Location

Kessler Foundation Research Center

West Orange, New Jersey, 07052, United States

Location

United Healthcare

Johnson City, New York, 13790, United States

Location

South Shore Neurologic Associates

Patchogue, New York, 11772, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Health Research Inc./Helen Hayes Hospital

West Haverstraw, New York, 10993, United States

Location

Guilford Neurologic Associates

Greensboro, North Carolina, 27405, United States

Location

FirstHealth of the Carolinas

Pinehurst, North Carolina, 28374, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Magee Rehabilitation Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. David's Rehabilitation Hospital

Austin, Texas, 78705, United States

Location

The Dallas VA

Dallas, Texas, 75216, United States

Location

Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (2)

• 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.

  PMID: 24526708 RESULT

• 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.

  PMID: 25653225 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Helen Rogers PT, PhD
• Organization: Innovative Neurotronics

hrogers@ininc.us

512-721-1922

Study Officials

• Francois Bethoux, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04

Locations

US (29)