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

NCT04973852 | Completed Results FDA Device

• 1 other identifier: HSC-MS-21-0262
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; high intensity; exoskeleton

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

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

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

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

  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

  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)

  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)

  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)

  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)

  Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)

Study Arms (1)

Exoskeleton

EXPERIMENTAL

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

Device: Ekso

Interventions

Ekso DEVICE

Exoskeleton walking

Exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

NeuroRecovery Research Center at TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (9)

• 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.

  PMID: 29081250 BACKGROUND

• 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.

  PMID: 32476619 BACKGROUND

• 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.

  PMID: 31434543 BACKGROUND

• 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.

  PMID: 25784587 BACKGROUND

• 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.

  PMID: 24515925 BACKGROUND

• 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.

  PMID: 31884902 BACKGROUND

• 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.

  PMID: 27526567 BACKGROUND

• 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.

  PMID: 26338433 BACKGROUND

• 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.

  PMID: 29547484 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Shuo-Hsiu Chang, PT, PhD
• Organization: The University of Texas Health Science Center at Houston

Shuo-Hsiu.Chang@uth.tmc.edu

713-799-7016

Study Officials

• Shuo-Hsiu (James) Chang

  The University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: October 6, 2021
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)