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

• Sponsor: Bioness Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01138995
• Collaborator: Medidata Solutions (Industry), University of Cincinnati (Other)
• Enrollment: 197
• Locations: 11
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site: 17.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sensorimotor Gait Disorder; Neurologic Ambulation Disorder; Gait, Drop Foot; Poststroke Hemiparesis; Post-Cerebrovascular Accident (CVA) Hemiparesis	Device: Ness L300; Device: Ankle-foot orthosis	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Leg Stimulator

Outcome Measures

Primary Outcome Measures

1. Ten Meter Walk Test (10mWT) [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.

Secondary Outcome Measures

1. Berg Balance Scale (BBS) Score [Week 30]

   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.

2. User Satisfaction [Week 30]

   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,

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Rancho Los Amigos National Rehabilitation Center	Downey	California	United States	90242-3496
2	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
3	Sharp Rehabilitation Center	San Diego	California	United States	92123
4	National Rehabilitation Hospital	Washington	District of Columbia	United States	20010
5	Brooks Center for Rehabilitation Studies	Jacksonville	Florida	United States	32216
6	Kansas University Medical Center	Kansas City	Kansas	United States	66160
7	Weill Cornell Medical Center	New York	New York	United States	10065
8	St.Charles Hospital & Rehabilitation	Port Jefferson	New York	United States	11777
9	The Drake Center /University of Cincinnati	Cincinnati	Ohio	United States	45216
10	UT Southwestern	Dallas	Texas	United States	75390-9055
11	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 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bioness Inc
• ClinicalTrials.gov Identifier: NCT01138995
• Other Study ID Numbers: CP-L300-0801, Rev. B
• First Posted: Jun 8, 2010
• Last Update Posted: Apr 28, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Bioness Inc: Poststroke/CVA hemiparesis; Drop Foot; Gait Disorders, Neurological; Gait, Drop foot
• Additional relevant MeSH terms: Stroke; Paresis; Peroneal Neuropathies; Gait Disorders, Neurologic; Disease

Study Results

Participant Flow

Arm/Group Title	Originial Control Group	Original Treatment Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	98	99
COMPLETED	88	74
NOT COMPLETED	10	25

Baseline Characteristics

Arm/Group Title	Originial Control Group	Original Treatment Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	98	99	197
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (10.9)	60.7 (12.2)	61.1 (11.6)
Sex: Female, Male (Count of Participants)
Female	31 31.6%	48 48.5%	79 40.1%
Male	67 68.4%	51 51.5%	118 59.9%
Region of Enrollment (participants) [Number]
United States	98 100%	99 100%	197 100%

Outcome Measures

1. Primary Outcome

Title	Ten Meter Walk Test (10mWT)
Description	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.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Originial Control Group	Original Treatment Group
Arm/Group Description	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.	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.
Measure Participants	98	99
Mean (Standard Deviation) [meters per second (m/s)]	0.15 (0.14)	0.14 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Originial Control Group, Original Treatment Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.75
	Comments
	Method	Fisher's combination test
	Comments	Between group difference for entire sample

2. Secondary Outcome

Title	Berg Balance Scale (BBS) Score
Description	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.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Originial Control Group	Original Treatment Group
Arm/Group Description	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.	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.
Measure Participants	98	99
Mean (Standard Deviation) [units on a scale]	3.75 (4.62)	1.97 (6.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Originial Control Group, Original Treatment Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.022
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	User Satisfaction
Description	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,
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

All randomized subjects were analyzed.

Arm/Group Title	Originial Control Group	Original Treatment Group
Arm/Group Description	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO)for 30 weeks.	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.
Measure Participants	98	99
Mean (Standard Deviation) [units on a scale]	19.1 (4.0)	21.8 (2.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Originial Control Group, Original Treatment Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse events were collected for both study arms from Baseline to 30 weeks post-randomization.
Arm/Group Title	Originial Control Group		Original Treatment Group
Arm/Group Description	The Control Group will walk with the a "usual" ankle-foot orthosis (AFO) for 30 weeks.		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.
All Cause Mortality
	Originial Control Group		Original Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Originial Control Group		Original Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/98 (7.1%)		15/99 (15.2%)
Blood and lymphatic system disorders
anemia requiring blood transfusion	0/98 (0%)	0	1/99 (1%)	1
Cardiac disorders
stroke/high blood pressure	1/98 (1%)	1	3/99 (3%)	3
Gastrointestinal disorders
bowel obstruction	0/98 (0%)	0	1/99 (1%)	1
General disorders
hospitalization general complaints	0/98 (0%)	0	1/99 (1%)	1
Hepatobiliary disorders
cholecystectomy	1/98 (1%)	1	1/99 (1%)	1
Immune system disorders
cancer	1/98 (1%)	1	0/99 (0%)	0
Infections and infestations
methicillin resistant Staphylococcus aureus	0/98 (0%)	0	1/99 (1%)	1
Musculoskeletal and connective tissue disorders
Bone fracture	2/98 (2%)	2	3/99 (3%)	3
Hemiparesis	1/98 (1%)	1	0/99 (0%)	0
Psychiatric disorders
mental depression and anxiety	0/98 (0%)	0	1/99 (1%)	1
Renal and urinary disorders
kidney damage due to dehydration	0/98 (0%)	0	1/99 (1%)	1
Reproductive system and breast disorders
ovarian mass	0/98 (0%)	0	1/99 (1%)	1
Respiratory, thoracic and mediastinal disorders
pneumonia/respiratory	1/98 (1%)	1	1/99 (1%)	1
Other (Not Including Serious) Adverse Events
	Originial Control Group		Original Treatment Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/98 (62.2%)		82/99 (82.8%)
Cardiac disorders
Atrial fibrillation or abnormal heartbeat	1/98 (1%)	1	1/99 (1%)	1
Ear and labyrinth disorders
Vertigo	0/98 (0%)	0	1/99 (1%)	1
Eye disorders
Eye irritation and hemorrhage	1/98 (1%)	2	0/99 (0%)	0
Gastrointestinal disorders
Nausea or abdominal pain	2/98 (2%)	2	2/99 (2%)	2
Immune system disorders
seasonal allergies	1/98 (1%)	1	0/99 (0%)	0
Infections and infestations
blister, folliculitis	5/98 (5.1%)	5	7/99 (7.1%)	11
Injury, poisoning and procedural complications
fall with or without injury	45/98 (45.9%)	71	56/99 (56.6%)	81
Metabolism and nutrition disorders
gout or diabetes	2/98 (2%)	2	0/99 (0%)	0
Musculoskeletal and connective tissue disorders
joint pain	21/98 (21.4%)	23	26/99 (26.3%)	33
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
cancer	0/98 (0%)	0	1/99 (1%)	1
Nervous system disorders
hypertonia, headache, dizziness, memory deficit	8/98 (8.2%)	9	8/99 (8.1%)	10
Psychiatric disorders
Fear or depression	1/98 (1%)	1	3/99 (3%)	3
Renal and urinary disorders
renal mass	0/98 (0%)	0	1/99 (1%)	1
Respiratory, thoracic and mediastinal disorders
asthma, cough, bronchitis	2/98 (2%)	3	3/99 (3%)	3
Skin and subcutaneous tissue disorders
localized skin redness, rash, irritation	35/98 (35.7%)	45	45/99 (45.5%)	68
Vascular disorders
Hypertension and/or flushing	5/98 (5.1%)	5	4/99 (4%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.