Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop

Not Applicable

Completed

Conditions: Neurologic Ambulation Disorder
Sensorimotor Gait Disorder
Poststroke Hemiparesis
Post-Cerebrovascular Accident (CVA) Hemiparesis
Gait, Drop Foot

Interventions: Device: Ankle-foot orthosis
Device: Ness L300

Registration Number: NCT01138995

Lead Sponsor: Bioness Inc

Brief Summary: The objective of this study is to determine the effectiveness of the NESS L300 (L300) in improving gait parameters, function, and quality of life among stroke subjects (greater than or equal to 3 months post stroke)with drop foot.

Detailed Description: Approximately 176 subjects with stroke that have drop foot will be enrolled from approximately 10 different sites in the United States depending on the rate of enrollment. This clinical study is proposed to show that the functional electrical stimulation (FES) delivered via the Ness L300 improves gait function, stroke-specific quality of life, and safety for persons with stroke.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 197

Inclusion Criteria

Have ankle dorsiflexion range of motion greater than or equal to neutral when assessed concurrent with test stimulation in sitting and standing and demonstrate adequate ankle and knee stability during gait at the time of screening
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 fixed ankle contracture at greater than or equal to 5 degrees of plantar flexion in the hemiplegic leg with the knee extended
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ankle-foot orthosis (AFO) Control Group	Ankle-foot orthosis	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.
Ness L300 Treatment Group	Ness L300	The Original Treatment Group will walk with the Ness L300 for 30 weeks.

Primary Outcome Measures

Name	Time	Method
Ten Meter Walk Test (10mWT)	Week 30	Determine gait velocity during a 10 meter walk test for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO). Long term device effect at comfortable gait speed in m/s. Walk test results at 30 weeks will be compared to baseline speed. The mean difference (improvement) between baseline and week 30 will be presented by study arm.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS) Score	Week 30	Clinical measurement of balance was recorded using the Berg Balance Scale which is a highly reliable and valid test used among persons with stroke. This Scale consists of 14 items/tasks of increasing difficulty graded on a five-point ordinal scale of zero to four where zero = participant is unable to perform the task and four = participant is independent in performance of task, such that overall total score may range from zero to 56 per participant. Mean Baseline and Mean Week 30 scores were calculated and used to determine change in mean score for each study group.
User Satisfaction	Week 30	Total user satisfaction as measured on 12 item User Satisfaction survey with maximum score 24, minimum 0, where higher score indicated greater satisfaction with device,

Trial Locations

Locations (11): The Drake Center /University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
UT Southwestern
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Dallas, Texas, United States
St.Charles Hospital & Rehabilitation
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Port Jefferson, New York, United States
University of Utah, School of Medicine
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Salt Lake City, Utah, United States
Rancho Los Amigos National Rehabilitation Center
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Downey, California, United States
Long Beach Memorial Medical Center
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Long Beach, California, United States
Sharp Rehabilitation Center
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San Diego, California, United States
Brooks Center for Rehabilitation Studies
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Jacksonville, Florida, United States
National Rehabilitation Hospital
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Washington, District of Columbia, United States
Weill Cornell Medical Center
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New York, New York, United States
Kansas University Medical Center
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Kansas City, Kansas, United States