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Search / Trial NCT05745298

The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury

Launched by UNIVERSITY OF MIAMI · Feb 16, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help people with acute spinal cord injuries improve their ability to cough without assistance. The researchers are using a method called Functional Electrical Stimulation (FES) combined with special breathing exercises, aiming to strengthen the muscles involved in coughing. This is important because a strong cough can help clear the lungs and prevent infections, which is crucial for recovery.

To be eligible for this study, participants should be adults between the ages of 65 and 74 who have had a spinal cord injury within the last year and are currently receiving rehabilitation. They should also be able to feel the effects of electrical stimulation during the treatment. However, certain individuals are not eligible, including those with specific medical conditions or devices such as pacemakers, and pregnant women. If someone joins the study, they can expect to undergo training that includes both the electrical stimulation and respiratory exercises, all while being closely monitored by the medical team.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date \< 12 months prior to enrollment
  • 2. Positive response to electrical stimulation through a palpable contraction
  • 3. Fluent in written and spoken English
  • Exclusion Criteria:
  • 1. Individuals who do not meet inclusion criteria
  • 2. Prisoners
  • 3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI
  • 4. Individuals with open tracheostomy
  • 5. Persons with pacemakers
  • 6. Pregnant women
  • 7. Persons with epilepsy
  • 8. Open wounds or metal implants at site of electrode placement
  • 9. Unresponsive to functional electrical stimulation
  • 10. Current diagnosis or history of thoraco-abdomino-pelvic cancer

About University Of Miami

The University of Miami, a leading academic institution, is dedicated to advancing medical research and improving patient care through innovative clinical trials. With a commitment to excellence in education and research, the university fosters collaboration among multidisciplinary teams to explore new therapies and treatment modalities. Its extensive clinical programs are supported by state-of-the-art facilities and a diverse patient population, enabling the exploration of cutting-edge solutions to complex health challenges. The University of Miami is poised to contribute significantly to the field of medicine through its rigorous scientific inquiry and a steadfast commitment to ethical research practices.

Locations

Miami, Florida, United States

Patients applied

0 patients applied

Trial Officials

Stephane Philippe-Ratway, MS, CCC-SLP

Principal Investigator

University of Miami

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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