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

This study has been completed.
Sponsor:
Collaborators:
Medidata Solutions
University of Cincinnati
Information provided by (Responsible Party):
Bioness Inc
ClinicalTrials.gov Identifier:
NCT01138995
First received: June 4, 2010
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Sensorimotor Gait Disorder
Neurologic Ambulation Disorder
Gait, Drop Foot
Poststroke Hemiparesis
Post-Cerebrovascular Accident (CVA) Hemiparesis
Device: Ness L300
Device: Ankle-foot orthosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop

Resource links provided by NLM:


Further study details as provided by Bioness Inc:

Primary Outcome Measures:
  • Ten Meter Walk Test (10mWT) [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    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:
  • Berg Balance Scale (BBS) Score [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    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,


Enrollment: 197
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Leg Stimulator

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138995

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bioness Inc
ClinicalTrials.gov Identifier: NCT01138995     History of Changes
Other Study ID Numbers: CP-L300-0801, Rev. B 
Study First Received: June 4, 2010
Results First Received: February 1, 2016
Last Updated: March 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Bioness Inc:
Poststroke/CVA hemiparesis
Drop Foot
Gait Disorders, Neurological
Gait, Drop foot

Additional relevant MeSH terms:
Disease
Stroke
Paresis
Gait Disorders, Neurologic
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2016