Sensorimotor Gait DisorderL300NCT01138995

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

A study testing Ness L300 and Ankle-foot orthosis in people with Sensorimotor Gait Disorder and Neurologic Ambulation Disorder, run by Bioness Inc at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sensorimotor Gait Disorder, Neurologic Ambulation Disorder, Gait, Drop Foot
What is being tested?: Ness L300 and Ankle-foot orthosis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 197 participants
Where: 11 sitesUnited States
Study dates: May 2010to Feb 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Sensorimotor Gait Disorder, Neurologic Ambulation Disorder, Gait, Drop Foot, Poststroke Hemiparesis, Post-Cerebrovascular Accident (CVA) Hemiparesis
Being tested: Ness L300, Ankle-foot orthosis
Keywords: Poststroke/CVA hemiparesis, Drop Foot, Gait Disorders, Neurological, Gait, Drop foot
Medical subject headings: Gait Disorders, Neurologic, Stroke, Paresis, Peroneal Neuropathies, Mobility Limitation, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ness L300Device
Also called Leg Stimulator
The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
Ankle-foot orthosisDevice
Also called drop foot orthotic
The Control Group will walk with a "usual" ankle-foot orthosis (AFO).

Study groups in NCT01138995
Study group	Role	What they receive
Ankle-foot orthosis (AFO) Control Group	Active comparator	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks. Receives: Device: Ankle-foot orthosis
Ness L300 Treatment Group	Experimental	The Original Treatment Group will walk with the Ness L300 for 30 weeks. Receives: Device: Ness L300

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 30

Secondary outcomes (2)

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.
Measured: 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,
Measured: Week 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Feb 2013

First posted8 Jun 2010 (estimated)
Study startMay 2010
Primary completionDec 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Sensorimotor Gait DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01138995
Sponsor's protocol ID: CP-L300-0801, Rev. B
Acronym: L300
Status last verified: Mar 2016
First submitted: 4 Jun 2010
Last updated: 28 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 29288141
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.
PubMed 24412265
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.
PubMed 23640829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury
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Active, not recruiting
Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.
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All Sensorimotor Gait Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop
ClinicalTrials.gov ID: NCT01138995
Acronym / sponsor ID: L300 / CP-L300-0801, Rev. B
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Bioness IncIndustry (pharma, biotech, devices)
Collaborators: Medidata Solutions, University of Cincinnati
Study start: May 2010
Primary completion: Dec 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 8 Jun 2010 (estimated)
Results: Posted 28 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ankle-foot orthosis (AFO) Control Group	Active comparator	Device: Ankle-foot orthosisThe Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.
Ness L300 Treatment Group	Experimental	Device: Ness L300The Original Treatment Group will walk with the Ness L300 for 30 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ness L300Also: Leg StimulatorThe Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.	Device	Ness L300 Treatment Group
Ankle-foot orthosisAlso: drop foot orthoticThe Control Group will walk with a "usual" ankle-foot orthosis (AFO).	Device	Ankle-foot orthosis (AFO) Control Group

Primary outcome

Ten Meter Walk Test (10mWT)
Time frame: Week 30
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.

2 secondary outcomes

Berg Balance Scale (BBS) Score
Time frame: Week 30
User Satisfaction
Time frame: Week 30

Results and safety

Results posted to the registry on 28 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Originial Control Group	98	88
Original Treatment Group	99	74

Primary outcome: Ten Meter Walk Test (10mWT)

Time frame: Week 30. Mean (Standard Deviation). Unit: meters per second (m/s)

Measure	Originial Control Group n = 98	Original Treatment Group n = 99
Value	0.15 (0.14)	0.14 (0.16)

Originial Control Group vs Original Treatment Group: p = 0.75, Fisher's combination test

Population analysed: Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Originial Control Group	7 of 98 (7.1%)	61 of 98 (62.2%)	Not reported
Original Treatment Group	15 of 99 (15.2%)	82 of 99 (82.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29288141Alenazi 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.
Derived from this study: PubMed 24412265O'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.
Derived from this study: PubMed 23640829Kluding 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.

Related trials for Sensorimotor Gait Disorder

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury Subacute
Active, not recruiting
Effects of Sensorimotor Insoles on Stability and Gait in Patients With Multiple Sclerosis.
Multiple Sclerosis
Recruiting
Use of CereGate Therapy for Freezing of Gait in PD
Parkinson Disease, Freezing of Gait

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kari Dunning, PT, Ph.D study chair

The Drake Center/University of Cincinnati

Michael O'Dell, MD study chair

Weill Medical College of Cornell University

Patricia Kluding, PT, Ph.D. principal investigator

University of Kansas

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ness L300 and Ankle-foot orthosis in people with Sensorimotor Gait Disorder and Neurologic Ambulation Disorder, run by Bioness Inc at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ten Meter Walk Test (10mWT) (time frame: Week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01138995, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.