Trial Outcomes & Findings for High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation (NCT NCT04973852)

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

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.

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.

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.

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.

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.

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 \[(average self-selected speed at 1 day after session 5 (about day 12)) - (average self-selected speed at pre intervention about 1 day prior to intervention)\]

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 \[(average fast gait speed at 1 day after session 5 (about day 12)) - (average fast gait speed at pre intervention about 1 day prior to intervention)\]

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 \[(total distance walked in 6 minutes at 1 day after session 5 (about day 12)) - (total distance walked in 6 minutes at pre intervention about 1 day prior to intervention)\]

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 \[(average reach distance at 1 day after session 5 (about day 12)) - (average reach distance at pre intervention (about 1 day prior to intervention))\]

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 \[(average step length at 1 day after session 5 (about day 12)) - (average step length at pre intervention about 1 day prior to intervention)\]

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 \[(average stride length at 1 day after session 5 (about day 12)) - (average stride length at pre intervention about 1 day prior to intervention)\]

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.

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 \[(average time spent in double limb support at 1 day after session 5 (about day 12)) - (average time spent in double limb at pre intervention about 1 day prior to intervention)\]

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 \[(average time spent in swing phase at 1 day after session 5 (about day 12)) - (average time spent in swing phase at pre intervention about 1 day prior to intervention)\]

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 \[(average time spent in stance phase at 1 day after session 5 (about day 12)) - (average time spent in stance phase at pre intervention about 1 day prior to intervention)\]

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.

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.

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.