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

Last updated: July 1, 2024
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Xcite Clinical Station

Clinical Study ID

NCT05745298
20221081
  • Ages > 18
  • All Genders

Study Summary

The overall objective of this study is to improve unaided cough with abdominal and latissimus dorsi functional electrical stimulation in conjunction with respiratory muscle training in individuals with acute spinal cord injuries.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motorincomplete and complete injuries) currently admitted to inpatient rehabilitationwith 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

Exclusion Criteria:

  1. Individuals who do not meet inclusion criteria

  2. Prisoners

  3. Concurrent traumatic brain injury determined by Rancho level of cognitivefunctioning < 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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Xcite Clinical Station
Phase:
Study Start date:
July 21, 2023
Estimated Completion Date:
July 21, 2025

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.