RecruitingNot ApplicableNCT04973852

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

20 participants

Start Date

Oct 6, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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

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Interventions

DEVICEEkso

Exoskeleton walking


Locations(1)

NeuroRecovery Research Center at TIRR Memorial Hermann

Houston, Texas, United States

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NCT04973852


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