NCT01138995已完成不适用
Functional Ambulation: Standard Treatment vs. Electronic Stimulation Therapy (FASTEST)Trial in Chronic Post-Stroke Subjects With Foot Drop
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioness Inc
- 入组人数
- 197
- 试验地点
- 21
- 主要终点
- Ten Meter Walk Test (10mWT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Ten Meter Walk Test (10mWT)
时间窗: 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.
次要结局
- Berg Balance Scale (BBS) Score(Week 30)
- User Satisfaction(Week 30)
研究者
研究点 (21)
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