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

• 6MWT [ Time Frame: Baseline, Week 0, 12, 30, 36, 42 ] [ Designated as safety issue: No ]
  Motor outcomes will be assessed with ambulation distance as measured in a timed 6MWT.
• Fall rate [ Time Frame: Pre-study, Baseline, Week 0,6,12,16,20,24,30,36,42 ] [ Designated as safety issue: Yes ]
  Changes fall rate from 6 months prior to study start to end of study.
• Berg Balance Scale (BBS) [ Time Frame: Baseline, Week 0, 6, 12, 30, 36, 42 ] [ Designated as safety issue: No ]
  Clinical measurement of balance using the Berg Balance Scale
• Stroke Impact Scales with Folstein Mini Mental State [ Time Frame: Baseline, Week 0, 6, 12, 30, 36, 42 ] [ Designated as safety issue: No ]
  Quality of life using the "Participation" subscale of Stroke Impact Scale (SIS) with Folstein Mini Mental State.
• Function Reach Test, Timed Up and Go Test, SIS-ADL, iADL, and Mobility [ Time Frame: Baseline, Week 0, 6, 12, 30, 36, 42 ] [ Designated as safety issue: No ]
  Functionality will be evaluted during the FRT, TUG, SIS-ADL,iADL, and Mobility

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.

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 FES delivered via the L300 improves gait function, stroke-specific quality of life, and safety for persons with stroke.

• Post-Stroke
• Sensorimotor Gait Disorder
• Neurologic Ambulation Disorder
• Gait, Drop Foot

• Device: Ness L300
  The L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
  Other Names:

  • Ness L300
  • FES
  • Leg Stimluator
• Device: Ness L300
  The Original Treatment Group will walk with the L300 for 42 week, and the Original Control Group will walk with a "usual" ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the L300 for a total of 12 weeks.
  Other Names:

  • Ness L300
  • L300
  • Leg stimulator
  • FES

• No Intervention: Originial Control Group
  The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the L300 for a total of 12 weeks.
  Interventions:

  • Device: Ness L300
  • Device: Ness L300
• Active Comparator: Original Treatment Group
  The Original Treatment Group will walk with the L300 for 42 weeks.
  Interventions:

  • Device: Ness L300
  • Device: Ness L300

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 LE 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 neurorehabilitation PT or 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

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• University of Cincinnati