High Intensity Training for Neurological Injury Using Overground Exoskeletons in Inpatient Rehabilitation
NCT ID: NCT04973852
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-10-06
2024-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Exoskeleton
5 sessions of overground ambulation with wearable exoskeleton where heart rate is monitored over each session.
Ekso
Exoskeleton walking
Interventions
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Ekso
Exoskeleton walking
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Shuo-Hsiu Chang
Assistant Professor
Principal Investigators
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Shuo-Hsiu (James) Chang
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Sciences Center at Houston
Locations
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NeuroRecovery Research Center at TIRR Memorial Hermann
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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James Chang
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HSC-MS-21-0262
Identifier Type: -
Identifier Source: org_study_id
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