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

Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop

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.

Study Overview

• Status: Completed
• Conditions: Gait, Drop Foot; Sensorimotor Gait Disorder; Neurologic Ambulation Disorder; Poststroke Hemiparesis; Post-Cerebrovascular Accident (CVA) Hemiparesis
• Intervention / Treatment: Device: Ankle-foot orthosis; Device: Ness L300

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.

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242-3496
      • Rancho Los Amigos National Rehabilitation Center
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Center
    • San Diego, California, United States, 92123
      • Sharp Rehabilitation Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • National Rehabilitation Hospital
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Brooks Center for Rehabilitation Studies
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
    • Port Jefferson, New York, United States, 11777
      • St.Charles Hospital & Rehabilitation
  • Ohio
    • Cincinnati, Ohio, United States, 45216
      • The Drake Center /University of Cincinnati
  • Texas
    • Dallas, Texas, United States, 75390-9055
      • UT Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ankle-foot orthosis (AFO) Control Group; The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.	Device: Ankle-foot orthosis; The Control Group will walk with a "usual" ankle-foot orthosis (AFO).; Other Names: drop foot orthotic
Experimental: Ness L300 Treatment Group; The Original Treatment Group will walk with the Ness L300 for 30 weeks.	Device: 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.; Other Names: Leg Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ten Meter Walk Test (10mWT)	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.	Week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS) Score	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.	Week 30
User Satisfaction	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,	Week 30

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. Erratum In: PM R. 2014 Oct;6(10):967.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (Estimate): June 8, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Poststroke/CVA hemiparesis; Drop Foot; Gait Disorders, Neurological; Gait, Drop foot
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Stroke; Disease; Paresis; Gait Disorders, Neurologic; Peroneal Neuropathies
• Other Study ID Numbers: CP-L300-0801, Rev. B