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

Poststroke/CVA Hemiparesis Clinical Trial

— L300  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138995
• Other study ID #: CP-L300-0801, Rev. B
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2010
• Last updated: August 18, 2015
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: August 2015
• Source: Bioness Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Gait Disorders, Neurologic
• Gait, Drop Foot
• Neurologic Ambulation Disorder
• Poststroke/CVA Hemiparesis
• Sensorimotor Gait Disorder

Intervention

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.
• Ness L300
The Original Treatment Group will walk with the Ness L300 for 42 weeks, 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 Ness L300 for a total of 12 weeks.

Locations

Country	Name	City	State
United States	The Drake Center /University of Cincinnati	Cincinnati	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Brooks Center for Rehabilitation Studies	Jacksonville	Florida
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Weill Cornell Medical Center	New York	New York
United States	St.Charles Hospital & Rehabilitation	Port Jefferson	New York
United States	University of Utah, School of Medicine	Salt Lake City	Utah
United States	Sharp Rehabilitation Center	San Diego	California
United States	National Rehabilitation Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Bioness Inc	Medidata Solutions, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10mWT	Determine gait velocity during a 10mWT for subjects using the L300 versus subjects using a standard "usual" ankle-foot orthosis (AFO).	Baseline, Week 0, 12, 30, 36, 42	No
Secondary	6MWT	Motor outcomes will be assessed with ambulation distance as measured in a timed 6MWT.	Baseline, Week 0, 12, 30, 36, 42	No
Secondary	Fall rate	Changes fall rate from 6 months prior to study start to end of study.	Pre-study, Baseline, Week 0,6,12,16,20,24,30,36,42	Yes
Secondary	Berg Balance Scale (BBS)	Clinical measurement of balance using the Berg Balance Scale	Baseline, Week 0, 6, 12, 30, 36, 42	No
Secondary	Stroke Impact Scales with Folstein Mini Mental State	Quality of life using the "Participation" subscale of Stroke Impact Scale (SIS) with Folstein Mini Mental State.	Baseline, Week 0, 6, 12, 30, 36, 42	No
Secondary	Function Reach Test, Timed Up and Go Test, SIS-ADL, iADL, and Mobility	Functionality will be evaluted during the FRT, TUG, SIS-ADL,iADL, and Mobility	Baseline, Week 0, 6, 12, 30, 36, 42	No