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NCT05745298NARecruiting

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

University of Miami

Start Date

7/21/2023

Completion Date

9/21/2028

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

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Xcite Clinical Station

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Conditions

Acute Spinal Cord Injury

Locations

University of Miami

Miami, Florida 33136

United States