PACTR201608001647143尚未招募未知
The effect of robotic exoskeleton gait rehabilitation on individuals with chronic spinal cord injury
niversity of Cape Town0 个研究点目标入组 48 人开始时间: 2016年5月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 65 Year(s)（—）
- 性别
- All
入选标准
- •¿Male or female individuals with a SCI (traumatic)
- •¿18 through to 65 years old
- •¿English speaking (Does not need to be 1st language but must be fluent)
- •¿Chronic (>1yr) spinal cord injury
- •¿Motor/Sensory incomplete (AIS B, C, D), with a neurological level of injury (NLI) between C1-C8 as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
- •¿Reliant upon a wheelchair as their primary mode of mobility
- •¿Sufficient anthropometrics and range of motion (ROM) to achieve a normal, reciprocal gait pattern within the EksoTM suit
- •oStanding height: 157cm ¿ 188cm
- •oMaximum hip width: 42cm
- •oUpper leg length (Femur): 51cm to 61.4cm
- •oLower Leg length (Tibia): 48cm to 63.4cm
- •oMaximum weight: 100 kilograms
- •oHip extension greater than or equal to 5 degrees
- •oKnee extension less than or equal to 12 degrees
- •oAnkle dorsiflexion greater than or equal to 0 degrees
- •¿Sufficient upper extremity (UE) strength to use a front wheeled walker (FWW) either by manual muscle testing (MMT) (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5) and/or by functional standing test with FWW. Participants with impaired hand function may use cuff grips.
- •¿Demonstrate adequate trunk stability and upper extremity strength to utilize EksoTM bionic walking suit as evidenced by the ability to complete a level (or near level) surface wheelchair to mat transfer with minimal assistance.
- •¿Medically stable and cleared by a physician for full weight bearing locomotor training including 15 minute standing frame trial to assess standing tolerance.
- •¿Severe osteoporosis: DEXA Z score < -2 of the hip or lumbar spine
排除标准
- •¿Non-traumatic SCI
- •¿Have trained in a robotic exoskeleton in the past
- •¿Performing any other form of locomotor training
- •¿Clinically Depressed (Beck Depression Inventory)
- •¿Any medical issue that in the opinion of the investigator precludes full weight bearing locomotor training including but not limited to:
- •oHeart or respiratory comorbidity
- •oSpinal instability (or spinal orthotic unless cleared by physician)
- •oAcute deep vein thrombosis (DVT) with activity restrictions
- •oSevere, recurrent autonomic dysreflexia (AD) requiring medical intervention
- •oHeterotopic ossification (HO) in the lower extremities resulting in ROM restrictions at the hips or knees
- •oTwo or more pathological fractures in the last 48 months in a major weight bearing bone (femur or tibia) in the lower extremity
- •oHip subluxation (x-rays will be obtained for individuals injured prior to 10 years of age.
- •¿Any medical issue that in the opinion of the investigator would affect participant safety either due to cognitive deficits/impulsivity, intolerance to mild exercise or other factors
- •¿Any issue that in the opinion of the investigator would confound results such as a concurrent neurological injury or disorder (other than SCI)
- •¿Modified Ashworth Scale (MAS) = 4 in any of the lower extremity joints (i.e scored a 4 on the scale (indicating rigidity in the joint) when testing joint movements in lower extremities (hip flexion/extension, knee flexion/extension, ankle dorsi/plantar flexion)
- •¿Skin integrity issues in areas that contact the device (including abdominal ostomies) or that would prohibit sitting
- •¿Z scores outside of recommended range (<-2)
研究者
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