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临床试验/NCT06780280
NCT06780280尚未招募2 期

Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness

Craig Hospital0 个研究点目标入组 25 人开始时间: 2025年3月20日最近更新:
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
25
主要终点
Adverse Events and feasibility

研究概览

简要总结

This proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (DoC) due to acquired brain injury (ABI). Recent practice guidelines highlight the need to develop interventions to arouse patients with DoC, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. New data indicates patients with chronic DoC may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. Interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. We hypothesize that walking in an overground robotic exoskeleton (ORE) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with DoC.

详细描述

The objective of this study is to evaluate the safety, feasibility and tolerability of using ORE therapy with individuals who meet criteria for DoC during inpatient rehabilitation while evaluating changes in behavioral performance, neurophysiology, and physiologic response to training. DoC numbers are very small so our goal is to gather this pilot data to support a future multi-site efficacy study with other TBIMS Center partners.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Individuals with DOC who are receiving inpatient rehabilitation

排除标准

  • 未提供

研究组 & 干预措施

Walking Intervention

Experimental

Overground walking with an exoskeleton

干预措施: Overground Walking (Other)

结局指标

主要结局

Adverse Events and feasibility

时间窗: four weeks

We will measure all adverse advents.

次要结局

  • Coma Recovery Scale-Revised(four weeks)

研究者

申办方类型
Other
责任方
Sponsor

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