RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-06
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04973852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to achieve adequate fit within the exoskeleton
  2. * Diagnosis of CVA or motor incomplete SCI (AIS C or D)
  3. * Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  4. * Intact skin on all surfaces in contact with device and load-bearing surfaces
  5. * Weight \<220 pounds
  1. * Pregnancy
  2. * Spinal instability
  3. * Unhealed limb or pelvic fractures or any condition restricting weight-bearing in limbs
  4. * Diagnosis of other neurological injuries other than CVA or SCI
  5. * Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
  6. * Colostomy
  7. * Decreased range of motion or contractures in legs (\>10° at hips, knees, or ankles)
  8. * Uncontrolled autonomic dysreflexia
  9. * Unresolved deep vein thrombosis
  10. * Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  11. * Inability to follow 3 step commands
  12. * Severe comorbidities: active infections, heart, lung, or circulatory conditions
  13. * Pressure sores, impaired skin integrity
  14. * Use of mechanical ventilation for respiratory support

Contacts and Locations

Study Contact

Shuo-Hsiu (James) Chang
CONTACT
713-799-7016
shuo-hsiu.chang@uth.tmc.edu
Marcie Kern
CONTACT
713-799-6995
marcia.kern@uth.tmc.edu

Principal Investigator

Shuo-Hsiu (James) Chang
PRINCIPAL_INVESTIGATOR
The University of Texas Health Sciences Center at Houston

Study Locations (Sites)

NeuroRecovery Research Center at TIRR Memorial Hermann
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Shuo-Hsiu (James) Chang, PRINCIPAL_INVESTIGATOR, The University of Texas Health Sciences Center at Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-06
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2021-10-06
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

  • spinal cord injury
  • high intensity
  • exoskeleton

Additional Relevant MeSH Terms

  • Spinal Cord Injuries