An Open, Longitudinal, Prospective, Non-randomized, Self-Controlled Feasibility Study to Investigate the Effect of the ReWalk™ Device on Mobility Outcomes in Patients With Chronic Spinal Cord Injury.
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 10-meter walking test (10MWT)
研究概览
简要总结
In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.
详细描述
In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Twenty one-hour training sessions are scheduled for each participant over a 10-week period. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (Lower Extremity Motor Score <20)
- •Motor level of injury from Cervical level 7 to Lumbar level 1, according to ASIA guidelines
- •Male and non-pregnant, non-lactating female
- •Age 18-55 years old
- •At least 12 months after injury
- •Able to stand or maintain upright position with or without using a standing device (e.g., 'Easy stand')
- •Able to sit with hips and knees ≥90° flexion
- •Height of 160 to 190 cm
- •Weight of <100 kg
排除标准
- •History of severe neurological injuries other than spinal cord injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
- •Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
- •Unstable spine or unhealed limbs or pelvic fractures
- •Limited range of motion (<90°) hip and knee joints, including severe contractures
- •Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
- •Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
- •Psychiatric or cognitive conditions that may interfere with the trial
- •Previous use of any exoskeletal robotic device
- •Patients incapable of providing informed consent
结局指标
主要结局
10-meter walking test (10MWT)
时间窗: 10 weeks
Change in score between 0 and 10 weeks.
次要结局
- 6-minutes walk test (6MWT)(10 weeks)
- Timed Up and Go (TUG) test(10 weeks)
- Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire(10 weeks)
- Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire(10 weeks)