Gait, Drop Foot, Neurologic Ambulation Disorder, Post-Cerebrovascular Accident (CVA) Hemiparesis, Poststroke Hemiparesis, Sensorimotor Gait Disorder
Conditions
Keywords
Poststroke/CVA hemiparesis, Drop Foot, Gait Disorders, Neurological, Gait, Drop foot
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.
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.
Interventions
DEVICENess 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.
DEVICEAnkle-foot orthosis
The Control Group will walk with a usual ankle-foot orthosis (AFO).
Sponsors
Medidata Solutions
University of Cincinnati
Bioness Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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, |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 99 |
| Total | 197 |
Baseline characteristics
| Characteristic | Originial Control Group | Original Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 10.9 | 60.7 years STANDARD_DEVIATION 12.2 | 61.1 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment United States | 98 participants | 99 participants | 197 participants |
| Sex: Female, Male Female | 31 Participants | 48 Participants | 79 Participants |
| Sex: Female, Male Male | 67 Participants | 51 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 61 / 98 | 82 / 99 |
| serious Total, serious adverse events | 7 / 98 | 15 / 99 |
Outcome results
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.
Time frame: Week 30
Population: Intent to treat analysis of 197 (98 Control and 99 Treatment) randomized subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Originial Control Group | Ten Meter Walk Test (10mWT) | 0.15 meters per second (m/s) | Standard Deviation 0.14 |
| Original Treatment Group | Ten Meter Walk Test (10mWT) | 0.14 meters per second (m/s) | Standard Deviation 0.16 |
p-value: 0.75Fisher's combination test
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.
Time frame: Week 30
Population: All randomized subjects are included in this analysis to determine change in mean score from Baseline to Week 30 in each study group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Originial Control Group | Berg Balance Scale (BBS) Score | 3.75 units on a scale | Standard Deviation 4.62 |
| Original Treatment Group | Berg Balance Scale (BBS) Score | 1.97 units on a scale | Standard Deviation 6.08 |
p-value: <0.022Wilcoxon (Mann-Whitney)
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,
Time frame: Week 30
Population: All randomized subjects were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Originial Control Group | User Satisfaction | 19.1 units on a scale | Standard Deviation 4 |
| Original Treatment Group | User Satisfaction | 21.8 units on a scale | Standard Deviation 2.9 |
p-value: <0.001Wilcoxon (Mann-Whitney)