Clinical Study of the L300 Versus Ankle-foot Orthosis (AF... | NCT01138995

Status Module

Name	Class
Medidata Solutions	INDUSTRY
University of Cincinnati	OTHER

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Eligibility Module

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

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
Rancho Los Amigos National Rehabilitation Center		Downey	California	90242-3496	United States
Long Beach Memorial Medical Center

PubMed Identifier	Type	Citation	Retractions
29288141	Derived	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.
24412265	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Originial Control Group	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Originial Control Group	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks. 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.
BG001	Original Treatment Group	The Original Treatment Group will walk with the Ness L300 for 42 weeks. 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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00098 BG00199 BG002197

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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

Posted

Mean

Standard Deviation

meters per second (m/s)

Week 30

ID	Title	Description
OG000	Originial Control Group	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.
OG001	Original Treatment Group	The Original Treatment Group will walk with the Ness L300 for 30 weeks. The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Units	Counts
Participants	OG00098 OG00199

Title

Denominators

Categories

Title	Measurements
	OG0000.15± 0.14 OG0010.14± 0.16

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Fisher's combination test	Between group difference for entire sample	0.75						2-Sided							No	Superiority or Other

Secondary

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.

All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.

Posted

Mean

Standard Deviation

units on a scale

Week 30

ID	Title	Description
OG000	Originial Control Group	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.
OG001	Original Treatment Group	The Original Treatment Group will walk with the Ness L300 for 30 weeks. 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.

Secondary

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,

All randomized subjects were analyzed.

Posted

Mean

Standard Deviation

units on a scale

Week 30

ID	Title	Description
OG000	Originial Control Group	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.
OG001	Original Treatment Group	The Original Treatment Group will walk with the Ness L300 for 30 weeks. The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
stroke/high blood pressure	Cardiac disorders	Non-systematic Assessment	non device related	EG0001 events1 affected98 at risk EG0013 events3 affected99 at risk
cholecystectomy	Hepatobiliary disorders	Non-systematic Assessment	non device related	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk
pneumonia/respiratory	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	non-device related	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk
cancer	Immune system disorders	Non-systematic Assessment	non-device related	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk
Bone fracture	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	non device related	EG0002 events2 affected98 at risk EG0013 events3 affected99 at risk
Hemiparesis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	non device related	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk
kidney damage due to dehydration	Renal and urinary disorders	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
anemia requiring blood transfusion	Blood and lymphatic system disorders	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
ovarian mass	Reproductive system and breast disorders	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
bowel obstruction	Gastrointestinal disorders	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
methicillin resistant Staphylococcus aureus	Infections and infestations	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
mental depression and anxiety	Psychiatric disorders	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
hospitalization general complaints	General disorders	Non-systematic Assessment	non device related	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
localized skin redness, rash, irritation	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00045 events35 affected98 at risk EG00168 events45 affected99 at risk
Eye irritation and hemorrhage	Eye disorders	Non-systematic Assessment	EG0002 events1 affected98 at risk EG0010 events0 affected99 at risk
seasonal allergies	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected99 at risk
hypertonia, headache, dizziness, memory deficit	Nervous system disorders	Non-systematic Assessment	EG0009 events8 affected98 at risk EG00110 events8 affected99 at risk
Nausea or abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected98 at risk EG0012 events2 affected99 at risk
Hypertension and/or flushing	Vascular disorders	Non-systematic Assessment	EG0005 events5 affected98 at risk EG0014 events4 affected99 at risk
joint pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00023 events21 affected98 at risk EG00133 events26 affected99 at risk
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
Fear or depression	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected98 at risk EG0013 events3 affected99 at risk
cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
gout or diabetes	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected98 at risk EG0010 events0 affected99 at risk
Atrial fibrillation or abnormal heartbeat	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected98 at risk EG0011 events1 affected99 at risk
asthma, cough, bronchitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events2 affected98 at risk EG0013 events3 affected99 at risk
renal mass	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected99 at risk
blister, folliculitis	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected98 at risk EG00111 events7 affected99 at risk
fall with or without injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG00071 events45 affected98 at risk EG00181 events56 affected99 at risk

ID	Term
D020233	Gait Disorders, Neurologic
D020521	Stroke
D010291	Paresis
D020427	Peroneal Neuropathies
D051346	Mobility Limitation
D009461	Neurologic Manifestations

ID	Term
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Originial Control Group	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.			7	98	61	98
EG001	Original Treatment Group	The Original Treatment Group will walk with the Ness L300 for 30 weeks. The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.			15	99	82	99