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

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.

• Ness L300 (Device), also known as Leg Stimulator: 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 (Device), also known as drop foot orthotic: The Control Group will walk with a "usual" ankle-foot orthosis (AFO).

Primary outcomes

• 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 outcomes

• 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,

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Ten Meter Walk Test (10mWT) (Primary), Mean, meters per second (m/s): Originial Control Group 0.15 +/- 0.14; Original Treatment Group 0.14 +/- 0.16 (p 0.75)
• Berg Balance Scale (BBS) Score (Secondary), Mean, units on a scale: Originial Control Group 3.75 +/- 4.62; Original Treatment Group 1.97 +/- 6.08 (p <0.022)
• User Satisfaction (Secondary), Mean, units on a scale: Originial Control Group 19.1 +/- 4.0; Original Treatment Group 21.8 +/- 2.9 (p <0.001)

Adverse events

Time frame: Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 29288141
• Results publication: 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. PMID 24412265
• Results publication: 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. PMID 23640829

• Kari Dunning, PT, Ph.D, Study chair, The Drake Center/University of Cincinnati
• Michael O'Dell, MD, Study chair, Weill Medical College of Cornell University
• Patricia Kluding, PT, Ph.D., Principal investigator, University of Kansas
• Steven R. Edgley, MD, Principal investigator, University of Utah
• Kathaleen P Brady, PT, NCS, Principal investigator, MedStar National Rehabilitation Network
• Trevor Paris, MD, Principal investigator, Brooks Rehabilitation
• Jerome Stenehjem, MD, Principal investigator, Sharp Rehabilitation Center
• John Thottakara, MD, Principal investigator, UT Southwestern
• Jun Zhang, MD, Principal investigator, St. Charles Hospital & Rehabilitation
• Ziyad Ayyoub, MD, Principal investigator, Rancho Los Amigos National Rehabilitation
• Diemha Hoang, MD, Principal investigator, Long Beach Memorial Medical Center