search
Back to results

High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation (HIT Exo IP)

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ekso
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, high intensity, exoskeleton

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to achieve adequate fit within the exoskeleton
  • Diagnosis of 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 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

Sites / Locations

  • NeuroRecovery Research Center at TIRR Memorial HermannRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exoskeleton

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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 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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 13, 2021
Last Updated
October 5, 2023
Sponsor
The University of Texas Health Science Center, Houston
search

1. Study Identification

Unique Protocol Identification Number
NCT04973852
Brief Title
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
Acronym
HIT Exo IP
Official Title
High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, high intensity, exoskeleton

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton
Arm Type
Experimental
Arm Description
5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session.
Intervention Type
Device
Intervention Name(s)
Ekso
Intervention Description
Exoskeleton walking
Primary Outcome Measure Information:
Title
Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session while Wearing Exoskeleton
Description
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)
Title
Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
Description
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)
Title
Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
Description
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)
Title
Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
Description
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)
Title
Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
Description
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)
Title
Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Secondary Outcome Measure Information:
Title
Change in Seated Dynamic Reach as Assessed by the Modified Functional Reach Test
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (step length parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (stride length parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (single support parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (double support parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (swing time parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (stance time parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (heel to heel base of support time parameter)
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Metabolic Expenditure during 10MWT, as Assessed by Oxygen Consumption
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Title
Change in Metabolic Expenditure during 6MWT, as Assessed by Oxygen Consumption
Description
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.
Time Frame
Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo-Hsiu (James) Chang
Phone
713-799-7016
Email
shuo-hsiu.chang@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marcie Kern
Phone
713-799-6995
Email
marcia.kern@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuo-Hsiu (James) Chang
Organizational Affiliation
The University of Texas Health Sciences Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroRecovery Research Center at TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Chang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29081250
Citation
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.
Results Reference
background
PubMed Identifier
32476619
Citation
Lotter 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.
Results Reference
background
PubMed Identifier
31434543
Citation
Hornby 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.
Results Reference
background
PubMed Identifier
25784587
Citation
Holleran 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.
Results Reference
background
PubMed Identifier
24515925
Citation
Holleran 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.
Results Reference
background
PubMed Identifier
31884902
Citation
Moore 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.
Results Reference
background
PubMed Identifier
27526567
Citation
Leech 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.
Results Reference
background
PubMed Identifier
26338433
Citation
Hornby 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.
Results Reference
background
PubMed Identifier
29547484
Citation
Holleran 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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs