NCT02417532已完成不适用
Safety and Feasibility Evaluation of Robot Assisted Physiotherapy Exercises With REX
Rex Bionics Plc12 个研究点 分布在 3 个国家目标入组 56 人开始时间: 2015年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 12
- 主要终点
- Adverse Events
研究概览
简要总结
Prospective, Open label, single arm, non-randomized, non-comparative registry study of Robot-Assisted Physiotherapy Exercises with the REX Robot powered exercise system in patients with Spinal cord or other injury preventing unsupported patient ambulation.
详细描述
The objective of this feasibility study is to evaluate the overall device safety when used in Spinal Cord Injury Hospitals or Rehabilitation Centers under the supervision of a physician and/or qualified rehabilitation specialists.
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
- 10 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Wheelchair user
- •Spinal Injury Levels of C4 down to L5
- •Has no outstanding skin integrity issues that could be effected by the REX device
- •Should be between approximately 1.42m and 1.93m in height. More specifically, REX is able to accommodate the following limb lengths:
- •Upper leg length : 380 - 470 mm
- •Lower leg length : 366 - 470 mm
- •Heel position (Ankle to hind foot) : 40 - 92 mm
- •Floor to ankle height (To be measured while wearing the shoe to be used for mobilising in REX) : 96 - 116 mm
- •Has a skeletal hip width of 380 mm or less (limit imposed by REX)
- •Is between 40 kg and 100 kg weight (limits imposed by REX)
- •Has the manual dexterity to work a joystick
- •Sufficient passive range of motion in the Hip, Knee and Ankle of at least
- •Hip 90 degrees flexion 15 degrees hip extension 20 degrees abduction 16 degrees adduction
- •Knee 0 degrees extension 93 degrees flexion
- •Ankle 20 degrees dorsiflexion (with weight bearing and 10 degrees knee flexion) 22 degrees dorsiflexion (with 93 degrees knee flexion) 10 degrees plantar flexion 9 degrees inversion 9 degrees eversion
- •Thigh lateral diameter of < 135 mm (230 mm above the knee joint line)
- •Calf lateral diameter of < 100 mm (90 mm below the knee joint line)
- •Manual dexterity to work a joystick with or without a T-Bar and use emergency stop button
- •No contraindications to standing or mobilising
- •Patients must choose to participate, and must have signed the informed consent document
排除标准
- •Patients who do not meet inclusion criteria or physician discretion.
- •Patients with history of impaired cardiac function who have been referred to and reviewed by a medical professional. With a decision made that they should not continue in the trial due to their impaired cardiac function.
- •Patients contraindicated to walk or stand
- •Patients with spinal injury outside Inclusion criteria
- •Withdrawal or refusal to sign informed consent
- •Any other contraindication based on physician discretion
- •Known allergy (skin contact) to materials used in Rex
结局指标
主要结局
Adverse Events
时间窗: 1 day
absence of unexpected serious adverse events
Ability to Transfer
时间窗: 1 day
Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX
Transfer Time
时间窗: 1 day
Time it took for participant to transfer into the Rex with or without supervision.
次要结局
- Timed up and go Test- Ability to Stand From Chair(1 Day)
- Participant Satisfaction Questionnaire(1 Day)
研究者
研究点 (12)
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