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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Device: Ekso


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exoskeleton<br>5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session. | Device: Ekso<br>* Exoskeleton walking<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session while Wearing Exoskeleton | 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 session 1 (about day 2) | 
| Percentage of Heart Rate Reserve 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. | During session 2 (about day 4) | 
| Percentage of Heart Rate Reserve 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. | During session 3 (about day 6) | 
| Percentage of Heart Rate Reserve 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. | During session 4 (about day 9) | 
| Percentage of Heart Rate Reserve 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. | 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. | 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. | 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. | Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 average step length (measured in centimeters) will be reported. | 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 average stride length (measured in centimeters) will be reported. | 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 average time spent in single limb support (measured as percentage of total gait cycle) will be reported. | 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 average time spent in double limb support (measured as percentage of total gait cycle) will be reported. | 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 average time spent in swing phase (measured as percentage of total gait cycle) will be reported. | 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 average time spent in stance phase (measured as percentage of total gait cycle) will be reported. | 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 average heel to heel base of support (measured in centimeters) will be reported. | 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 average oxygen cost will be reported as VO2 peak during 10MWT. | 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 average oxygen cost will be reported as VO2 peak during 6MWT. | Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord injury, high intensity, exoskeleton