Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 495
- 试验地点
- 58
- 主要终点
- Stroke Impact Scale (SIS) Composite Score
研究概览
简要总结
To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.
详细描述
This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).
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
- None
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
- •Patient history of stroke (ischemic and/or hemorrhagic).
- •Patient is at least 6 months post stroke.
- •Patient has hemiplegia/hemiparesis.
- •Patient has inadequate dorsiflexion during swing phase of gait, resulting in inadequate limb clearance.
- •Patient is not currently using Functional Electrical Stimulation for the treatment of footdrop.
- •Patient is a minimum of 30 days post inpatient or outpatient stroke, cardiac, pulmonary, or physical rehabilitation on the lower extremity.
- •Patient is a minimum of 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement).
- •Patient is a minimum of 90 days post myocardial infarction.
- •Patient is a minimum of 90 days post stenting procedure (i.e. peripheral, cardiac, carotid, and/or renal).
- •Patient is a minimum of 6 months post CABG or cardiac valve procedure.
- •Patient is able to walk at least 10 meters with or without an assist device (excluding an AFO or WalkAide device).
- •Patient has an initial gait speed > 0.0 m/s and < 0.8 m/s.
- •Patient has a positive response to peroneal nerve stimulation testing, resulting adequate dorsiflexion of the ankle.
- •Patient has adequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score >17 within 30 days prior to enrollment.
- •Patient has completed a full neurological assessment within 30 days prior to enrollment.
- •Patient is eligible for Medicare or Medicare Choice/Advantage benefits at the time of enrollment
- •Patient is able and willing to comply with study procedures, including follow-up requirements.
- •Patient is able and willing to give written informed consent.
排除标准
- •Patient is less than 6-months post stroke.
- •Patient has inadequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score < 17 within 30 days prior to enrollment.
- •Patient has ankle joint instability other than foot drop.
- •Patient is less than 30 days post inpatient or outpatient: stroke, cardiac, pulmonary, or any type of physical rehabilitation on the lower extremity at time of enrollment.
- •Patient has need for an AFO for stance control of the foot, ankle and/or knee.
- •Patient has an initial gait speed of 0.8 m/s or greater classified as a full community walker (independent in all home and community activities).
- •Patient is not able to safely clear toes in swing phase on the involved lower extremity, defined as >-5° plantar flexion, with the device determined at fitting visit.
- •Patient has been diagnosed with peripheral neuropathy and symptoms obstruct or limit ambulation or participation in study procedures.
- •Patient has been diagnosed with significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication.
- •Patient has underlying condition(s) that would limit study participation such as severe hypertonicity resulting in the need for more involved orthotic strategies or excessive dysesthetic pain secondary to neurological involvement.
- •Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- •Patient is NYHA Class III or IV.
- •Patient has malignant skin lesion below the knee on the affected lower extremity.
- •Patient has history of seizure disorder and on seizure medications.
- •Patient has aphasia, defined as incapacity to verbalize commands.
- •Patient has Beck Depression Index score of > 29 indicating severe depression.
- •Patient has a life expectancy less than 12 months.
- •Patient has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation, TENS).
- •Patient is less than 6 months free from Botulinum Toxin (Botox) injection in the lower extremity.
- •Patient has baclofen pump with unstable dosing in the last 3 months.
- •Patient is unable or unwilling to comply with study procedures, including follow-up requirements.
- •Patient is participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results.
- •Patient is unable or unwilling to give written informed consent.
结局指标
主要结局
Stroke Impact Scale (SIS) Composite Score
时间窗: 6 months
The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.
Gait Velocity
时间窗: 6 months
Improved ambulation status, specific to increase in gait velocity (m/s)
Device Related Serious Adverse Events
时间窗: 6 months
The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).
次要结局
- Modified Emory Functional Ambulation Profile Total Score(6 months)
- Six Minute Walk Test(6 months)
- Modified Emory Functional Ambulation Profile Floor Time(6 months)
- Modified Emory Functional Ambulation Profile Stair Time(6 months)
- Berg Balance Scale(6 months)
- Modified Emory Functional Ambulation Profile Carpet Time(6 months)
- Modified Emory Functional Ambulation Profile Timed up and Go(6 months)
- Modified Emory Functional Ambulation Profile Obstacle Course(6 months)