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

NCT01138995 | Completed Results DMC

• 1 other identifier: CP-L300-0801, Rev. B
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Berg Balance Scale (BBS) Score

  Week 30

• User Satisfaction

  Week 30

Study Arms (2)

Ankle-foot orthosis (AFO) Control Group

ACTIVE COMPARATOR

The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.

Device: Ankle-foot orthosis

Ness L300 Treatment Group

EXPERIMENTAL

The Original Treatment Group will walk with the Ness L300 for 30 weeks.

Device: Ness L300

Interventions

Ness L300 DEVICE

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

Also known as: Leg Stimulator

Ness L300 Treatment Group

Ankle-foot orthosis DEVICE

The Control Group will walk with a "usual" ankle-foot orthosis (AFO).

Also known as: drop foot orthotic

Ankle-foot orthosis (AFO) Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioness Inc: lead
• Medidata Solutions: collaborator
• University of Cincinnati: collaborator

Study Sites (11)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242-3496, United States

Location

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

Sharp Rehabilitation Center

San Diego, California, 92123, United States

Location

National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Brooks Center for Rehabilitation Studies

Jacksonville, Florida, 32216, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

St.Charles Hospital & Rehabilitation

Port Jefferson, New York, 11777, United States

Location

The Drake Center /University of Cincinnati

Cincinnati, Ohio, 45216, United States

Location

UT Southwestern

Dallas, Texas, 75390-9055, United States

Location

University of Utah, School of Medicine

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke; Paresis; Peroneal Neuropathies; Mobility Limitation; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Keith McBride, CTO
• Organization: Bioness

Keith.McBride@bioness.com

661-362-4866

Study Officials

• Kari Dunning, PT, Ph.D

  The Drake Center/University of Cincinnati

  STUDY CHAIR

• Michael O'Dell, MD

  Weill Medical College of Cornell University

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 8, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 28, 2016
• Results First Posted: April 28, 2016

Record last verified: 2016-03

Locations

US (11)