Clinical trial NCT01138995: Clinical Study of the L300 Versus Ankle-foot Orthosis (AFO) on Post-Stroke Subjects With Foot Drop
Official title: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorimotor Gait Disorder
Neurologic Ambulation Disorder
Gait, Drop Foot
Poststroke Hemiparesis
Post-Cerebrovascular Accident (CVA) Hemiparesis
Keywords: Poststroke/CVA hemiparesis
Drop Foot
Gait Disorders, Neurological
Gait, Drop foot
Lead sponsor: Bioness Inc
Sponsor class: INDUSTRY
Collaborators: name: Medidata Solutions
name: University of Cincinnati
First posted: 2010-06-08
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ten Meter Walk Test (10mWT)
timeFrame: Week 30
Secondary outcomes:
measure: Berg Balance Scale (BBS) Score
timeFrame: Week 30
measure: User Satisfaction
timeFrame: Week 30
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Rehabilitation Center
state: California
city: Washington
country: United States
facility: National Rehabilitation Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Brooks Center for Rehabilitation Studies
state: Florida
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Port Jefferson
country: United States
facility: St.Charles Hospital & Rehabilitation
state: New York
city: Cincinnati
country: United States
facility: The Drake Center /University of Cincinnati
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, School of Medicine
state: Utah
Study officials:
affiliation: The Drake Center/University of Cincinnati
name: Kari Dunning, PT, Ph.D
role: STUDY_CHAIR
affiliation: Weill Medical College of Cornell University
name: Michael O'Dell, MD
role: STUDY_CHAIR
affiliation: University of Kansas
name: Patricia Kluding, PT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Steven R. Edgley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedStar National Rehabilitation Network
name: Kathaleen P Brady, PT, NCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooks Rehabilitation
name: Trevor Paris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sharp Rehabilitation Center
name: Jerome Stenehjem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern
name: John Thottakara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Charles Hospital & Rehabilitation
name: Jun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rancho Los Amigos National Rehabilitation
name: Ziyad Ayyoub, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Long Beach Memorial Medical Center
name: Diemha Hoang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.