Effect of Mobility Training Using Robotic Exoskeletons on Functional Recovery in Individuals With Severe Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in 10 Meter Walk Test
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the Ekso robotic exoskeleton in persons affected by a severe stroke.
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Primary Objectives:
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To determine if a structured high-dosage exoskeleton training program (EXTP) results in clinically significant gains in walking recovery in individuals affected by severe stroke.
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To determine whether timing of EXTP delivery (i.e., sub-acute vs. chronic) and severity (non-ambulators vs. limited house-hold ambulators) affects the improvement in gait speed and overall function following the EXTP training protocol.
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To determine whether maintenance or further improvement in gait speed can be achieved by an intensive follow-up program of either a traditional rehabilitation program (TRP) or extended EXTP.
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Secondary Objectives:
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To determine the effect on functional walking endurance as assessed by the 6 minute walk test and 10 meter walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals.
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To determine the effect on functional balance, as assessed by the Berg Balance Scale, Functional Gait Assessment and Five times sit to stand measure as assessed by the 6 minute walk test, in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting for post stroke individuals.
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To determine the effect on stroke recovery, as assessed by the step counter of task specific training in high-dosage exoskeleton training program (EXTP) vs. traditional rehabilitation program (TRP) carried in an outpatient setting
详细描述
*Procedures During Screening Process:
This study will involve recruitment of individuals who have experienced a severe stroke as well as patients with similar neurological weakness from the inpatient setting, outpatient clinics, as well as day rehabilitation sites through The Rehabilitation Institute of Chicago and Northwestern Memorial Hospital.
Members of the research team will perform the initial screening of potential subjects. These clinicians will determine study eligibility based on the inclusion and exclusion criteria provided by Ekso Bionics in accordance with the medical recommendations of Dr. Todd Kuiken.
Potential subjects will be asked questions regarding their medical history and current level of function. If the subject meets the criteria, researchers will then provide the subject with a consent form. The researchers will discuss the objectives, study protocol, and the risks and benefits of the study with each subject. The subjects will be given time to review the form and ask any questions about the study.
Once each subject has provided informed consent, he or she will undergo a screening process to assess joint range of motion, muscular strength (via manual muscle test), and any spasticity present (via Modified Ashworth Scale). These measures will be used to determine subject qualification based on inclusion and exclusion criteria. Vital signs (including heart rate, blood pressure and oxygen saturation) will be assessed at baseline, after each session, and during sessions as needed based on subject's signs and symptoms. Oxygen saturation and heart rate will be monitored using a pulse oximeter. Blood pressure will be assessed with a manual blood pressure cuff and stethoscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be post stroke or have similar neurological weakness (2 weeks up to 6 months post and 6 months or more post)
- •Subjects must be between 18-85 years of age
- •Subjects must be able to fit into device and have joint motion to allow ambulation in device
- •Subjects must be able to tolerate upright standing for 30 minutes
- •Subjects must have sufficient upper extremity strength and balance to allow ambulation with device
- •Subjects must have walking speed <0.4m/s, including non-ambulators
- •Subjects must be able and willing to give written consent and comply with study procedures, including follow-up visits
- •Mini Mental Status Exam (MMSE) score >17
- •Medical clearance from physician
排除标准
- •Subjects must not be shorter than 60 inches or taller than 74 inches
- •Subjects must not weight greater than 220 lbs
- •Joint contractures of the hip, knee, or ankle that might limit normal ROM during ambulation
- •Medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
- •History of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device
- •Cognitive and/or communicative disability (e.g. due to brain injury). Patients must be able to follow directions and demonstrate learning capability
- •Pregnancy
- •Untreated deep vein thrombosis (DVT)
结局指标
主要结局
Change in 10 Meter Walk Test
时间窗: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The test will be recorded 2 times, with adequate rest in between. The average of the 2 times should be recorded.
Change in 6 Minute Walk Test With VO2 Analysis
时间窗: Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit)
The 6MWT measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change distance for people with sub-acute stroke is 60.98 meters15. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.
次要结局
- Change in Patient Health Questionnaire-9(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Fugl-Meyer Assessment of Motor Recovery After Stroke(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Mini Mental Status Examination(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Modified Falls Efficacy Scale(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Manual Muscle Test(Session 1 (pre test, initial visit) and Session 10 (post test, 10 weeks))
- Change in Modified Ashworth Test(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Functional Reach Test(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Activities Specific Balance Confidence Scale(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Community Participation Indicators(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Visual Analog Scale(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in The Psychosocial Impact Of Assistive Devices Scale(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Stroke Specific Quality of Life(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Range of Motion(Session 1 (pre test, initial visit) and Session 32 (post test, 10 weeks))
- Change in Stops While Walking Test(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Berg Balance Scale(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in 5 Times Sit to Stand Test(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Timed Up And Go(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
- Change in Modified Functional Reach(Session 1 (pre test, initial visit), Session 12 (week 4), Session 22 (week 7), Session 10 (post test, 10 weeks) and Session 33 (3 month follow-up visit))
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab