Clinical Investigation on the Safety and Performance of the ABLE Daily to Assist People With Spinal Cord Injury in Performing Ambulatory Functions in Home and Community Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety of the device
研究概览
简要总结
The goal of this clinical trial is to to confirm the safety and performance of the ABLE Daily to perform ambulatory functions in home and community settings for people with spinal cord injury.
The experimental period will cover the training period with the ABLE Daily exoskeleton (3 weeks of use at the investigational site with a total of 9 sessions) and the home period (12 weeks of personal use at home and community environments).
详细描述
The ABLE Daily Exoskeleton is a wearable powered lower-limb exoskeleton that actively assists individuals with spinal cord injury to stand up, walk, ascend and descend a ramp of 5 degrees and sit down. The device consists of a rigid brace that attaches to the torso, legs and feet of the user via straps and supports. It is a bilateral robotic exoskeleton with four battery-powered motors that drive the knee and hip joints assisting in flexion-extension. The other degrees of freedom of the hip and knee joints are restricted. The ankle joint of the exoskeleton is passively articulated with a spring within a limited range of motion.
The experimental period will cover the training period happening at the investigational site where the participants and their companions will be trained 3 times a week. They will then have to perform a community skills test, if passed they will be allowed to take the exoskeleton home and use it in their daily life for 12 weeks. Pre and post assessments will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •At least 18 years old
- •Chronic SCI (>6 months)
- •Injury at levels T1 to L5 (AIS A to D)
- •Walking Index for Spinal Cord Injury (WISCI) score 0 until 9
- •Height between 150-200 cm
- •Weight less than 100 kg
- •Capable of giving informed consent on their own
- •Able to train (at least) 3 days/week
- •Able to have at least 1 companion / buddy who can attend a minimum of two of the training sessions, besides the final assessment, and who will learn how to assist them at home and in the community (ideally two companions)
- •Proficiency in walking with the ABLE Exoskeleton
- •At least 8 weeks with minimal use (less than 5 sessions) of wearable robotic exoskeletons for gait assistance at the start of the study.
排除标准
- •High risk of fractures due to osteoporosis, a dual energy X-ray absorptiometry (DEXA)-scan at the hip, distal femur, and proximal tibia BMD score
- •Fragility fractures of the lower limbs in the last 2 years
- •Deterioration >3 in the International Standards for Neurological Classification of SCI (ISNCSCI) score in the last 4 weeks
- •Spinal instability, like spondylolisthesis
- •Disorders of the arms and hands that make walking with crutches impossible
- •Modified Ashworth Scale (MAS) >3 in lower limbs
- •Cardiovascular health issues which prevent the participant from training
- •Instability to tolerate 10 minutes of standing without clinical symptoms of orthostatic hypotension
- •Psychological, cognitive issues, or any other condition that does not allow a participant to follow study procedures
- •Medically unstable due to severe comorbidities, including any condition that a physician deems inappropriate for completing study participation
- •Skin problems in areas that would be in contact with the device
- •Height, width, weight, or other anatomical limitations (such as differences in leg length) incompatible with the device
- •Insufficient joint range of motion (ROM) for the device
- •Known pregnancy
研究组 & 干预措施
Intervention with exoskeleton
The participants will receive training sessions with the ABLE Daily at Sint Maartenskliniek. After they pass the skills and knowledge exam, they will receive the ABLE Daily at their disposal at home for twelve weeks.
干预措施: ABLE Daily (Device)
结局指标
主要结局
Safety of the device
时间窗: Through study completion (up to 16 weeks)
The total number of adverse events and serious adverse events related to the investigational device at the end of the study will be measured.
Performance of the device during the training period
时间窗: Through the training period (up to 3 weeks) from training session 1-9
The number and type of device errors or use errors during the training period.
Performance of the device in the home/community period
时间窗: Through the home/community period (up to 12 weeks)
The amount of use of the device during the home/community use period, as measured by the number of sessions and the walking time, number of steps, and distance walked per session.
次要结局
- Perceived health status(At baseline and the final assessment at end of the study (16 weeks))
- Gait performance while using the device (6MWT)(After training period (3 weeks) and at the final assessment at the end of the study (16 weeks))
- User satisfaction(At the final assessment at the end of the study (16 weeks))
- Gait performance using the device: 10-Meter Walk Test (10MWT)(After training period (3 weeks) and at the final assessment at the end of the study (16 weeks))