High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation

The University of Texas Health Science Center, Houston2 个研究点分布在 1 个国家目标入组 11 人开始时间: 2021年10月6日最近更新: 2026年4月15日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: The University of Texas Health Science Center, Houston
入组人数: 11
试验地点: 2
主要终点: Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to see if it's possible to reach high cardiovascular intensity training parameters (exercise at a rate that elevates heart rate to the level recommended for improving strength and endurance) while walking in a wearable robotic exoskeleton. This study will also evaluate if exercising at high intensity will lead to improvement in walking ability. Participants in this study will be asked to attend 5 walking training sessions using Ekso exoskeleton. There will be two additional sessions, one before and one after the five training sessions. At these two sessions, study participants will be asked to participate in seated balance, walking speed and endurance tests and breathing assessments.

详细描述

The purpose of this study is to determine the feasibility and potential efficacy to implement high cardiovascular intensity training parameters (70-80% heart rate reserve) with the use of overground wearable robotic exoskeletons in an inpatient rehabilitation setting for locomotor recovery.

The second aim is to investigate the potential functional improvements in gait after receiving high-intensity locomotor training with an overground exoskeleton, as measured on the 10-meter walk test and six-minute walk test.

研究设计

研究类型: Interventional
分配方式: Na
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: 否

入选标准

•Able to achieve adequate fit within the exoskeleton
•Diagnosis of CVA or motor incomplete SCI (AIS C or D)
•Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
•Intact skin on all surfaces in contact with device and load-bearing surfaces
•Weight <220 pounds

排除标准

•Pregnancy
•Spinal instability
•Unhealed limb or pelvic fractures or any condition restricting weight-bearing in limbs
•Diagnosis of other neurological injuries other than CVA or SCI
•Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
•Colostomy
•Decreased range of motion or contractures in legs (>10° at hips, knees, or ankles)
•Uncontrolled autonomic dysreflexia
•Unresolved deep vein thrombosis
•Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
•Inability to follow 3 step commands
•Severe comorbidities: active infections, heart, lung, or circulatory conditions
•Pressure sores, impaired skin integrity
•Use of mechanical ventilation for respiratory support

研究组 & 干预措施

Exoskeleton

Experimental

5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session.

干预措施: Ekso (Device)

结局指标

主要结局

Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session

时间窗: During session 5 (about day 11)

Heart rate will be monitored continuously and recorded every 5 minutes throughout the session (each session lasts about 60 minutes). Heart rate reserve (HRR) is maximum heart rate (HRmax) minus resting heart rate (HRrest). Target HR ranges will be calculated using age-predicted maximum heart rate (HRmax = 208 - {0.7 \* age\]) and Karvonen formula (target HRR (70%) = (\[0.7 \* (HRmax - HRrest)\] + HRrest) and (target HRR (80%) = (0.8 \* (HRmax - HRrest)\] + HRrest). The percentage of HRR achieved during the exoskeleton session is calculated as the percentage of HR readings during the session that are within the 70-80% target HR zone.

Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session while Wearing Exoskeleton

时间窗: During session 1 (about day 2)

Change in Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)

时间窗: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)

During the 10 Meter Walk Test, four marks will be placed on the ground at 0,2,12 and 14 meters. Subjects will walk a total of 14 meters, where the middle 10 meters (between marks 2 and 12 meters) will be timed and recorded as their gait speed. Subjects will complete two attempts at their fastest pace. The two trials will be averaged and reported as fast gait speed. The change in fast gait speed will be reported as \[(average fast gait speed at 1 day after session 5 (about day 12)) - (average fast gait speed at pre intervention about 1 day prior to intervention)\]

Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)

时间窗: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)

During the 10 Meter Walk Test, four marks will be placed on the ground at 0,2,12 and 14 meters. Subjects will walk a total of 14 meters, where the middle 10 meters (between marks 2 and 12 meters) will be timed and recorded as their gait speed. Subjects will complete two attempts at their self-selected pace. The two trials will be averaged and reported as self-selected speed. The change in self-selected speed will be reported as \[(average self-selected speed at 1 day after session 5 (about day 12)) - (average self-selected speed at pre intervention about 1 day prior to intervention)\]

Change in Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT)

时间窗: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)

The 6 Minute Walk Test will measure the distance subjects can walk over six minutes. Subjects will walk along a 100-foot hallway as many times as they can in 6 minutes. Subjects are allowed to rest as needed; however, the timer continues to run for 6 minutes consecutively, whether they are standing or walking. The change in walking endurance will be reported as \[(total distance walked in 6 minutes at 1 day after session 5 (about day 12)) - (total distance walked in 6 minutes at pre intervention about 1 day prior to intervention)\]