Spinal Cord InjuriesHIT Exo IPNCT04973852
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
A study testing Ekso in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Ekso
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 25 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NeuroRecovery Research Center at TIRR Memorial Hermann
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Ekso
- Keywords
- spinal cord injury, high intensity, exoskeleton
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EksoDevice
Exoskeleton walking
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton | Experimental | 5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session. Receives: Device: Ekso |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Secondary outcomes (10)
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))]
Measured: 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)]
Measured: 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)]
Measured: 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.
Measured: 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)]
Measured: 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)]
Measured: 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)]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start6 Oct 2021
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston
- Investigators
- Shuo-Hsiu (James) Chang, Principal investigator, The University of Texas Health Sciences Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973852
- Sponsor's protocol ID
- HSC-MS-21-0262
- Acronym
- HIT Exo IP
- Status last verified
- Feb 2025
- First submitted
- 13 Jul 2021
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brazg G, Fahey M, Holleran CL, Connolly M, Woodward J, Hennessy PW, Schmit BD, Hornby TG. Effects of Training Intensity on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):944-954. doi: 10.1177/1545968317731538. Epub 2017 Oct 30.
PubMed 29081250Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.
PubMed 32476619Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
PubMed 31434543Holleran CL, Rodriguez KS, Echauz A, Leech KA, Hornby TG. Potential contributions of training intensity on locomotor performance in individuals with chronic stroke. J Neurol Phys Ther. 2015 Apr;39(2):95-102. doi: 10.1097/NPT.0000000000000077.
PubMed 25784587Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.
PubMed 24515925Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.
PubMed 31884902Leech KA, Hornby TG. High-Intensity Locomotor Exercise Increases Brain-Derived Neurotrophic Factor in Individuals with Incomplete Spinal Cord Injury. J Neurotrauma. 2017 Mar 15;34(6):1240-1248. doi: 10.1089/neu.2016.4532. Epub 2017 Jan 18.
PubMed 27526567Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
PubMed 26338433Holleran CL, Hennessey PW, Leddy AL, Mahtani GB, Brazg G, Schmit BD, Hornby TG. High-Intensity Variable Stepping Training in Patients With Motor Incomplete Spinal Cord Injury: A Case Series. J Neurol Phys Ther. 2018 Apr;42(2):94-101. doi: 10.1097/NPT.0000000000000217.
PubMed 29547484
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT04973852
- Acronym / sponsor ID
- HIT Exo IP / HSC-MS-21-0262
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, high intensity, exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton | Experimental | Device: Ekso5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EksoExoskeleton walking | Device | Exoskeleton |
Primary outcome
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session
Time frame: During session 1 (about day 2)
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 Readings Within the Target Zone Achieved During HIT Gait Training Session
Time frame: During session 2 (about day 4)
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 Readings Within the Target Zone Achieved During HIT Gait Training Session
Time frame: During session 3 (about day 6)
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 Readings Within the Target Zone Achieved During HIT Gait Training Session
Time frame: During session 4 (about day 9)
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 Readings Within the Target Zone Achieved During HIT Gait Training Session
Time frame: 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.
Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Time frame: 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 Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Time frame: 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 Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT)
Time frame: 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)]
10 secondary outcomes
Change in Seated Dynamic Reach as Assessed by the Modified Functional Reach Test
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)
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)
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)
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)
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)
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)
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)
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
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
Time frame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29081250Brazg G, Fahey M, Holleran CL, Connolly M, Woodward J, Hennessy PW, Schmit BD, Hornby TG. Effects of Training Intensity on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):944-954. doi: 10.1177/1545968317731538. Epub 2017 Oct 30.
- Background: PubMed 32476619Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.
- Background: PubMed 31434543Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
- Background: PubMed 25784587Holleran CL, Rodriguez KS, Echauz A, Leech KA, Hornby TG. Potential contributions of training intensity on locomotor performance in individuals with chronic stroke. J Neurol Phys Ther. 2015 Apr;39(2):95-102. doi: 10.1097/NPT.0000000000000077.
- Background: PubMed 24515925Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.
- Background: PubMed 31884902Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.
- Background: PubMed 27526567Leech KA, Hornby TG. High-Intensity Locomotor Exercise Increases Brain-Derived Neurotrophic Factor in Individuals with Incomplete Spinal Cord Injury. J Neurotrauma. 2017 Mar 15;34(6):1240-1248. doi: 10.1089/neu.2016.4532. Epub 2017 Jan 18.
- Background: PubMed 26338433Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
- Background: PubMed 29547484Holleran CL, Hennessey PW, Leddy AL, Mahtani GB, Brazg G, Schmit BD, Hornby TG. High-Intensity Variable Stepping Training in Patients With Motor Incomplete Spinal Cord Injury: A Case Series. J Neurol Phys Ther. 2018 Apr;42(2):94-101. doi: 10.1097/NPT.0000000000000217.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuo-Hsiu (James) Chang principal investigator
The University of Texas Health Sciences Center at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ekso in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Heart Rate Readings Within the Target Zone Achieved During HIT Gait Training Session (time frame: During session 1 (about day 2)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973852, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.