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临床试验/ACTRN12618000626268
ACTRN12618000626268已完成未知

Determining the effect on functional ability and quality of life of a lower limb robotic exoskeleton in patients with Spinal cord InjuRy (SIR HELLEN).

niversity of Newcastle0 个研究点目标入组 7 人开始时间: 2018年4月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
7

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Diagnosis of traumatic or non-traumatic SCI at least 3 months prior to enrolment
  • 2.Resident of the Hunter region
  • 3.18 years of age or older
  • 4.Discharged from inpatient rehabilitation programs
  • 5.Severe mobility impairment and reliant on wheelchair, mobility aid, or the assistance of others for standing activities ( scores < /=5 on the mobility assessment of SCIM-III)

排除标准

  • 1.Weight between 40 kg and 100kg; height between 4’8” and 6'4 (as per the recommendations of the robotic manufacturer)
  • 2.Pregnancy
  • 3.Unstable or severe cardiac or respiratory compromise
  • 4.Nonconsolidated fractures in lower limbs/pelvis/spine or diagnosed severe osteopenia ( t-score less than or equal to -2.5)
  • 5.Significant cognitive impairment (Montreal Cognitive Assessment Score of less than 19)
  • 6.Any medical condition which limits the ability to exercise in an upright position. This includes: pressure sores in contact with the exoskeleton, lower limb heterotrophic ossification, severe lower limb muscle contracture, spinal instability, acute deep vein thrombosis, recurrent attacks of autonomic dysreflexia requiring medical intervention, hip subluxation, a history of pathological fractures in the lower limbs in the last 2 years)

研究者

发起方
niversity of Newcastle

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