The Use of the Exoskeleton Robotic Device in the Rehabilitation of Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Change in Functional Independence Measure
研究概览
简要总结
Background: Traumatic brain injury (TBI) is one of the leading causes of disability in the United States. The EKSO GT Bionics® (EKSO®) is a robotic exoskeleton approved by the Federal Drug Administration (FDA) for rehabilitation following a cerebrovascular accident (CVA or stroke) and recently received approval for use in patients with TBI. The aim of the study was to examine if the use of exoskeleton rehabilitation in patients with TBI will produce beneficial outcomes. Methods: This retrospective chart-review reports the use of the (EKSO®) robotic device in the rehabilitation of patients with TBI compared to patients with CVA. The investigators utilized data from a single, private rehabilitation hospital for patients that received post-CVA or post-TBI robotic exoskeleton intervention. All patients that used the exoskeleton were discharged from the hospital between 01/01/2017 to 04/30/2020. Ninety-four percent (94%) of patients in the CVA groups and 100% of patients in the TBI group were of Hispanic or Latino ethnicity. Gains in total Functional Independence Measure (FIM), walking and cognition, and length of stay in the rehabilitation facility were measured. Results: Patients in the TBI group (n=11) were significantly younger than the patients in the CVA group (n=66; p< 0.05). Both groups spent a similar amount of time active, number of steps taken, and the number of sessions in the exoskeleton. Both groups also started with similar admission FIM scores. The FIM gain in the TBI group was similar to that of the CVA group (37.5 and 32.0 respectively). The length of stay between groups was not different either. Conclusions: The use of exoskeleton rehabilitation in patients with TBI appear to produce similar outcomes as for patients with CVA, prompting further attention of this intervention for this type of injury.
详细描述
Study Design and Setting
This is an observational, retrospective, chart review cohort study of patients from a private single rehabilitation hospital. Study approval was granted by the local Institutional Review Board and conformed to the Declaration of Helsinki and the US Federal Policy for the Protection of Human Subjects. Due to the retrospective nature of the study, a full waiver of authorization under the Health Insurance Portability and Accountability Act (1996) was submitted by the study team and approved by the Institutional Review Board.
Participants
Inclusion and Exclusion criteria: Subjects in the TBI group included patients who suffered a TBI and who used the EKSO® bionic exoskeleton during their rehabilitation treatment from 01/01/2017 to 04/30/2020. Subjects in the CVA group included all patients in the hospital that used the EKSO® during their rehabilitation process during the same period of the patients in the TBI group. Patients were excluded if their injury type was outside the scope of the current study. The registered nurse at the rehabilitation facility identified the patients based on the inclusion criteria, and this was verified by the doctor in physical therapy who oversees the rehabilitation hospital patient population. Approval and implementation of the EKSO® bionic device at the hospital commenced in 2014 for patients that suffered a CVA and spinal cord injury. Main indications for the use of the EKSO® during rehabilitation included a height range between 1.56 to 1.9 meters and a patient's weight equal to or less than 100kg. Stable blood pressure was required, with the ability to follow one to two steps commands, and the patient should also have demonstrated a normal range of motion in hips, knees, and ankles.
Variables
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Main indications for the use of the EKSO® during rehabilitation included a height range between 1.56 to 1.9 meters and a patient's weight equal to or less than 100kg.
- •Stable blood pressure was required, with the ability to follow one to two steps commands, and the patient should also have demonstrated a normal range of motion in hips, knees, and ankles.
- •Patient must have suffered a traumatic brain injury or stroke
排除标准
- •Patients were excluded if their injury type was outside the scope of the current study.
结局指标
主要结局
Change in Functional Independence Measure
时间窗: Ten weeks
Increase in FIM from Admission to Discharge
次要结局
- Time active in the exoskeleton(Inpatient stay at the rehabilitation hospital)
- Number of steps taken in the exoskeleton(Inpatient stay at the rehabilitation hospital)
研究者
Lisa Trevino
Vice President
DHR Health Institute for Research and Development
