Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
NCT ID: NCT01138995
Last Updated: 2016-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
197 participants
INTERVENTIONAL
2010-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ankle-foot orthosis (AFO) Control Group
The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.
Ankle-foot orthosis
The Control Group will walk with a "usual" ankle-foot orthosis (AFO).
Ness L300 Treatment Group
The Original Treatment Group will walk with the Ness L300 for 30 weeks.
Ness L300
The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Interventions
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Ness L300
The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Ankle-foot orthosis
The Control Group will walk with a "usual" ankle-foot orthosis (AFO).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have had at least one stroke of any etiology (e.g., ischemic, hemorrhagic,etc.) experienced greater than or equal to 3 months prior to study enrollment, as confirmed by independent medical records, and result in drop foot sufficient to require prior or current prescription for and/or use of an AFO
* Have adequate cognition and communication abilities for informed consent, training and instructions, use of the L300, and provide feedback, to be demonstrated by either the subjects scoring greater than or equal to 24 (out of a possible 30) on the Mini Mental State Examination, or having a competent caregiver for these purposes
* Must be 18 years or older
* Have the ability to safely walk at least 10-meters with a maximum of 1 person assist
* Have a self-selected 10-meter gait speed of less than or equal to 0.8m/s at the time of assessment
* Have inadequate dorsiflexion/limb clearance or unable to achieve normal heel strike on ambulation without AFO
* Be medically stable
Exclusion Criteria
* Have excessive pain in the affected leg, as measured by a score greater than or equal to 4 on a 10-point visual analog scale
* Participation, within the past 3 months, currently, or during the course of the study in any interventional clinical studies without the Sponsor's approval
* Have a demand-type cardiac pacemaker, defibrillator, or any electrical or metallic implant
* Have a lower motor neuron disease or injury with inadequate response to stimulation
* Have significant swelling/edema in the leg extending up to the knee
* Have a history of chronic skin problems/conditions or cancerous lesion present or suspected in close proximity ot the expected site for L300 stimulation
* Are pregnant or plan on becoming pregnant in the next 45 weeks
* Have had botulinum toxin(type a or b) to the hemiplegic leg or arm within the past six weeks or plan to have botulinum toxin treatments during the course of the study
* Expectation of a significant change in the subject's spasticity medications during the course of the study for the effected leg
* Have unstable seizure disorder (average of greater or equal to 2 seizures per month)
* Have a pre-existing significant orthopedic conditions that are, a that investigator's discretion, determined as likely to limit ambulatory progress (e.g., total hip replacement \[non-metallic\], total knee replacement \[non-metallic\], limited lower extremity (LE) range of motion (ROM), rheumatoid arthritis, osteoarthritis, or other fracture or dislocation that underlies the expected site for L300 stimulation)
* Have a complete hemisensory loss ipsilateral to foot drop
* Used the L300 or other FES device for foot drop (e.g., Odstock Drop Foot System (ODFS), WalkAide by Innovation Neurotronics, etc.) for greater than or equal to 3 hours within the last 6 months prior to study enrollment
* Have major post-stroke depression (PHQ-9 greater than or equal to 10) that is not medically managed with antidepression medication and/or psychotherapy
* Currently or planning on participating in a neuro-rehabilitation physical therapy (PT) or occupational therapy (OT) program or new independent exercise programs with enrolled in the study. However, injury or a change in condition requiring PT or OT that would not affect gait outcomes maybe assessed by an off-site study committee, on a case-by-case basis
18 Years
ALL
No
Sponsors
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Medidata Solutions
INDUSTRY
University of Cincinnati
OTHER
Bioness Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Kari Dunning, PT, Ph.D
Role: STUDY_CHAIR
The Drake Center/University of Cincinnati
Michael O'Dell, MD
Role: STUDY_CHAIR
Weill Medical College of Cornell University
Patricia Kluding, PT, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Kansas
Steven R. Edgley, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Kathaleen P Brady, PT, NCS
Role: PRINCIPAL_INVESTIGATOR
MedStar National Rehabilitation Network
Trevor Paris, MD
Role: PRINCIPAL_INVESTIGATOR
Brooks Rehabilitation
Jerome Stenehjem, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp Rehabilitation Center
John Thottakara, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern
Jun Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
St. Charles Hospital & Rehabilitation
Ziyad Ayyoub, MD
Role: PRINCIPAL_INVESTIGATOR
Rancho Los Amigos National Rehabilitation
Diemha Hoang, MD
Role: PRINCIPAL_INVESTIGATOR
Long Beach Memorial Medical Center
Locations
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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Sharp Rehabilitation Center
San Diego, California, United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Brooks Center for Rehabilitation Studies
Jacksonville, Florida, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Weill Cornell Medical Center
New York, New York, United States
St.Charles Hospital & Rehabilitation
Port Jefferson, New York, United States
The Drake Center /University of Cincinnati
Cincinnati, Ohio, United States
UT Southwestern
Dallas, Texas, United States
University of Utah, School of Medicine
Salt Lake City, Utah, United States
Countries
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References
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Alenazi AM, Alshehri MM, Alothman S, Rucker J, Dunning K, D'Silva LJ, Kluding PM. Functional Reach, Depression Scores, and Number of Medications Are Associated With Number of Falls in People With Chronic Stroke. PM R. 2018 Aug;10(8):806-816. doi: 10.1016/j.pmrj.2017.12.005. Epub 2017 Dec 26.
O'Dell MW, Dunning K, Kluding P, Wu SS, Feld J, Ginosian J, McBride K. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. PM R. 2014 Jul;6(7):587-601; quiz 601. doi: 10.1016/j.pmrj.2014.01.001. Epub 2014 Jan 9.
Kluding PM, Dunning K, O'Dell MW, Wu SS, Ginosian J, Feld J, McBride K. Foot drop stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke. 2013 Jun;44(6):1660-9. doi: 10.1161/STROKEAHA.111.000334. Epub 2013 May 2.
Other Identifiers
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CP-L300-0801, Rev. B
Identifier Type: -
Identifier Source: org_study_id
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