Clinical trial NCT04973852: High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
Official title: High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
high intensity
exoskeleton
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session while Wearing Exoskeleton
timeFrame: During session 1 (about day 2)
measure: Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
timeFrame: During session 2 (about day 4)
measure: Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
timeFrame: During session 3 (about day 6)
measure: Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
timeFrame: During session 4 (about day 9)
measure: Percentage of Heart Rate Reserve Achieved During HIT Gait Training Session
timeFrame: During session 5 (about day 11)
measure: Change in Self Selected Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Fast Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Walking Endurance as Assessed by the 6 Minute Walk Test (6MWT)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Secondary outcomes:
measure: Change in Seated Dynamic Reach as Assessed by the Modified Functional Reach Test
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (step length parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (stride length parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (single support parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (double support parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (swing time parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (stance time parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Spatial-Temporal Gait Parameters as assessed by the GAITRite pressure map (heel to heel base of support time parameter)
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Metabolic Expenditure during 10MWT, as Assessed by Oxygen Consumption
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
measure: Change in Metabolic Expenditure during 6MWT, as Assessed by Oxygen Consumption
timeFrame: Pre Intervention (about 1 day prior to intervention) and 1 Day after session 5 (about day 12)
Other outcomes:
Locations:
city: Houston
country: United States
facility: NeuroRecovery Research Center at TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Sciences Center at Houston
name: Shuo-Hsiu (James) Chang
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.