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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Exoskeleton walking
NeuroRecovery Research Center at TIRR Memorial Hermann
Houston, Texas, United States
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session
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.
Time frame: During session 1 (about day 2)
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session
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.
Time frame: During session 2 (about day 4)
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session
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.
Time frame: During session 3 (about day 6)
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session
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.
Time frame: During session 4 (about day 9)
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session
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.
Time frame: During session 5 (about day 11)
Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
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 \[(average self-selected speed at 1 day after session 5 (about day 12)) - (average self-selected speed at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
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 \[(average fast gait speed at 1 day after session 5 (about day 12)) - (average fast gait speed at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT)
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 \[(total distance walked in 6 minutes at 1 day after session 5 (about day 12)) - (total distance walked in 6 minutes at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Seated Dynamic Reach as Assessed by the Modified Functional Reach Test
The Modified Functional Reach Test measures the maximum distance an individual can reach forward from a seated position. This will be reported as an average of three trials. Change in seated dynamic reach is reported as \[(average reach distance at 1 day after session 5 (about day 12)) - (average reach distance at pre intervention (about 1 day prior to intervention))\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Step Length Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average step length (measured in centimeters) will be reported as \[(average step length at 1 day after session 5 (about day 12)) - (average step length at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Stride Length Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average stride length (measured in centimeters) will be reported as \[(average stride length at 1 day after session 5 (about day 12)) - (average stride length at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Single Support Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average time spent in single limb support (measured in seconds) will be reported as \[(average time spent in single limb support at 1 day after session 5 (about day 12)) - (average time spent in single limb at pre intervention about 1 day prior to intervention)\] - negative value indicates a reduction in single limb support time post intervention.
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Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Double Support Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average time spent in double limb support (measured in seconds) will be reported as \[(average time spent in double limb support at 1 day after session 5 (about day 12)) - (average time spent in double limb at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Swing Time Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average time spent in swing phase (measured in seconds) will be reported as \[(average time spent in swing phase at 1 day after session 5 (about day 12)) - (average time spent in swing phase at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Stance Time Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average time spent in stance phase (seconds) will be reported as \[(average time spent in stance phase at 1 day after session 5 (about day 12)) - (average time spent in stance phase at pre intervention about 1 day prior to intervention)\]
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Spatial-Temporal Gait Parameters as Assessed by the GAITRite Pressure Map (Heel to Heel Base of Support Time Parameter)
The GAITRite pressure map will be used during the 10MWT. This pressure map will digitally record the subject's footprints' placement and pressure as they walk over it during the 10MWT. This assessment will indicate several temporospatial gait parameters. The Change in average heel to heel base of support (measured in centimeters) will be reported as \[(average heel to heel base of support at 1 day after session 5 (about day 12)) - (average heel to heel base of support at pre intervention about 1 day prior to intervention)\] - a negative values indicates reduction in base of support which indicates improvement in gait.
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Metabolic Expenditure During 10MWT, as Assessed by Oxygen Consumption
Change in metabolic expenditure during 10MWT will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally. The change in oxygen cost from baseline will be reported as VO2 peak during 10MWT.
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Change in Metabolic Expenditure During 6MWT, as Assessed by Oxygen Consumption
Change in metabolic expenditure during 6MWT will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally. The change in oxygen cost from baseline will be reported as VO2 peak during 6MWT.
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)