TERMINATED

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training

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 research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Official Title

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

Quick Facts

Study Start:2024-10-01
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06478680

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. * 18 years of age or older
  2. * English or Spanish-speaking
  3. * A diagnosis of stroke (intracerebral hemorrhage or acute ischemic stroke)
  4. * Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic
  1. * Unable to follow 1-step commands
  2. * \> 220 pounds (100 kg)
  3. * Height \< 5'0" or \> 6'4"
  4. * Unable to take a few steps with assistance
  5. * A score of ≥ 50/56 on Berg Balance Scale (BBS)
  6. * A score of ≥ 26/30 on Functional Gait Assessment (FGA)
  7. * Resting blood pressure \>180/110 mmHg
  8. * Resting heart rate \> 120 bpm
  9. * Severe cardiac disease (New York Heart Association Classification IV)
  10. * Severe spasticity (Modified Ashworth score \> 3)
  11. * Unstable spine or unhealed pelvic/limb fractures
  12. * Active heterotrophic ossification impacting lower extremity range of motion
  13. * Significant lower or upper extremity contractures
  14. * Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
  15. * Pregnancy
  16. * Colostomy
  17. * Poor skin integrity in areas in contact with the EksoGTTM
  18. * Unresolved deep vein thrombosis
  19. * Lower limb prosthesis or amputation
  20. * Leg length discrepancies \> 0.5 inches for upper legs, 0.75 inches for lower legs
  21. * ROM restrictions preventing normal, reciprocal gait
  22. * Inability to stand for \> 3 minutes due to pain or orthostatic hypotension
  23. * Pusher syndrome
  24. * Cortical blindness

Contacts and Locations

Principal Investigator

Soo Yeon Sun, PhD
PRINCIPAL_INVESTIGATOR
Alvernia University
Kelley Limbauan, PT, DPT, NCS
PRINCIPAL_INVESTIGATOR
Good Shepherd Rehabilitation Network

Study Locations (Sites)

Good Shepherd Rehabilitation
Allentown, Pennsylvania, 18103
United States

Collaborators and Investigators

Sponsor: Alvernia University

  • Soo Yeon Sun, PhD, PRINCIPAL_INVESTIGATOR, Alvernia University
  • Kelley Limbauan, PT, DPT, NCS, PRINCIPAL_INVESTIGATOR, Good Shepherd Rehabilitation Network

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 Date2024-10-01
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

  • health literacy
  • balance
  • compliance to therapy
  • gait function
  • high intensity gait training
  • exoskeleton

Additional Relevant MeSH Terms

  • Stroke
  • Gait, Hemiplegic