A Comparative Analysis of Lower-Limb Exoskeleton Technology for Non-Ambulatory Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 10 meter walk test (10MWT)
研究概览
简要总结
The purpose of this study is to compare two types of wearable lower-extremity exoskeletons -a self-balancing device lower-extremity exoskeleton and a user-balancing device lower-extremity exoskeleton-to better understand their effects on the physiological responses to walking and the user experience in people with spinal cord injury.
详细描述
Although Lower Limb Exoskeleton technology holds promise for improving mobility and independence in people with Spinal Cord Injury, limited research has examined the physiological and psychological effects of walking with self-balancing lower limb exoskeleton technology compared to systems that require user-operated assistive aids. Moreover, no studies to date have directly compared the short- and long-term outcomes of two lower limb exoskeleton technology types: (1) self-balancing and (2) user-balancing. To address this gap, this study will conduct a head-to-head comparison of self-balancing and user-balancing lower limb exoskeleton technology in individuals with motor-complete (ASIA Impairment Scale Classification [AIS] A/B) Spinal Cord Injury-a population that remains underrepresented in rehabilitation robotics research despite advances in the field.
Study participants will complete 5 walking sessions and 2 test sessions with two different exoskeleton devices in a randomized order. During each test session, data will be collected using motion sensors, portable metabolic monitors, and muscle sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subacute to chronic SCI (≥ 3mths post injury)
- •Motor-complete (ASIA Impairment Scale classification A/B)
- •Injury level T3-T11
- •Age 18-70 yrs
- •Height between 5'1" and 6'1"
- •Weight <200 lbs (90kg)
- •Seated hip width < 42cm
- •Standing tolerance > 15mins
- •Have sufficient upper limb strength to use a platform rolling walker, rolling walker, or forearm crutches
- •Currently medically cleared and enrolled in the Shepherd Center Beyond Therapy program
- •Medically cleared for weight-bearing activities
- •Able to follow directions to safely participate in assessments
排除标准
- •Existing skin lesions or wounds
- •Hip or knee contracture > 10 degrees or ankle contracture > 5 degrees
- •Severe or uncontrolled spasticity
- •Non-healing fractures
- •Uncontrolled autonomic dysreflexia
- •Heart or peripheral vascular condition
- •Pregnancy
- •Active heterotopic ossification
- •Active deep vein thrombosis
- •Cognitive deficits that make it difficult for participants to follow verbal instructions or making it unsafe to participate in assessments.
- •Any reason the principal investigator feels the potential participant may not be safe to participate in the study
研究组 & 干预措施
User-balancing lower limb exoskeleton
Participants will use the user-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.
干预措施: Ekso Indego Therapy (Device)
Self-balancing lower limb exoskeleton
Participants will use the self-balancing lower limb exoskeleton for 5 walking sessions and then complete a test session.
干预措施: Wandercraft Atalante X (Device)
结局指标
主要结局
10 meter walk test (10MWT)
时间窗: 1 year
This will be measured as the participant walks a distance of 10 meters at their self-selected (or comfortable) walking speed. Three 10-meter walk trials will be completed by each participant at each time point. The average of three 10MWT walking speeds will be analyzed and reported. This measure will be recorded in seconds and converted to meters/s with higher values indicating faster speed and lower values indicating slower speeds. Self-selected walking speed is highly correlated with functional ability and dependence.
6 minute walk test (6MWT)
时间窗: 1 year
This is a measurement of endurance and functional ability that assesses the participants ability to walk a distance (meters) over a time period of 6 minutes. It is measured in distance with greater distances indicating improved levels of endurance and functional ability.
次要结局
- Walking economy(1 year)
- Rating of Perceived Exertion(1 year)
- Total hemoglobin concentration(1 year)
- User-experience survey(1 year)
- Neuromuscular activation of specified muscles(1 year)
研究者
Maegan Tucker
Assistant Professor
Georgia Institute of Technology