Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in 10 meter walk test from baseline in gait speed
研究概览
简要总结
Many people with spinal cord injury are no longer able to walk and must use wheelchairs for mobility. These individuals experience greater rates of depression and lower quality of life. Many of these individuals express a strong desire to walk again, and report many psychosocial benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs allow only limited community access, creating an additional obstacle to seeking out meaningful social roles in the community. Currently, there is new technology called robotic exoskeletons that would allow people with spinal cord injury to walk. These robotic exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to community access. Current research has examined training with robotic exoskeletons indoors over level surfaces in clinical settings. This study will examine the potential for everyday use, including ramps, stairs, curbs and indoor and outdoor use.
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
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI level C6-8, T1-T12; L1-L5 incomplete or complete
- •Be able to physically fit into the exoskeleton device;
- •Be able to tolerate upright standing for a minimum of 30 minutes;
- •Have sufficient upper body strength to use forearm crutches in standing and during ambulation (including full triceps strength and good hand function);
- •Have hip, knee, and ankle range of motion within normal functional limits of walking;
- •Have the ability to follow directions and demonstrate learning capacity;
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Cervical level SCI above C6
- •History of severe osteoporosis;
- •Weight above 220 pounds;
- •Femur length above 47 cm or below 36 cm
- •Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation;
- •Cognitive and/or communication disability (e.g. due to brain injury);
- •History of significant problems with skin break down or current skin break down;
- •Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity);
- •Pregnancy;
- •Cardiovascular conditions such as history of heart attack, high blood pressure, pacemaker, arrhythmia, heart failure, or stroke.
研究组 & 干预措施
ReWalk training
干预措施: ReWalk Rehabilitation 2.0 (Device)
结局指标
主要结局
Change in 10 meter walk test from baseline in gait speed
时间窗: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Measure the time in second for and individual to walk 10 meters. The test is Performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."
Distance able to reach while standing and sitting
时间窗: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Change in 6 Minute Walk Test from baseline in distance, RPE and oxygen uptake
时间窗: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The VO2 MAX data is collected during the test every 10 seconds
Time and assistive level to negotiate stairs, ramps, curbs, and turning.
时间窗: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
次要结局
- Pain measure by the Visual Analogue Scale(Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks))
- Patient perception of Quality of Life(Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks))
- The Patient Health Questionnaire(Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks))
- The Psychosocial Impact of Assistive Devices Scale(Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks))
- Self reported Spinal Cord Independence Measure in activities of daily living(Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks))
- Activities-specific Balance Confidence Scale(Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks))
研究者
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab