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 Miami1 site in 1 country50 target enrollmentJuly 21, 2023

ConditionsAcute Spinal Cord Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Spinal Cord Injury
Sponsor: University of Miami
Enrollment: 50
Locations: 1
Primary Endpoint: Percentage change in peak cough flow (PCF)
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 21, 2023

End Date

September 21, 2027

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Stephane Philippe-ratway

Speech Pathologist

University of Miami

Eligibility Criteria

Inclusion Criteria

•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
•Positive response to electrical stimulation through a palpable contraction
•Fluent in written and spoken English

Exclusion Criteria

•Individuals who do not meet inclusion criteria
•Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI
•Individuals with open tracheostomy
•Persons with pacemakers
•Pregnant women
•Persons with epilepsy
•Open wounds or metal implants at site of electrode placement
•Unresponsive to functional electrical stimulation
•Current diagnosis or history of thoraco-abdomino-pelvic cancer

Outcomes

Primary Outcomes

Percentage change in peak cough flow (PCF)

Time Frame: one week pre-intervention and up to 4 weeks post-intervention

Assessing the percentage change in peak cough flow as assessed by peak expiratory flow meter with a pillow face mask.

Percentage change in peak expiratory flow

Time Frame: one week pre-intervention and up to 4 weeks post-intervention

Assessing the percentage change in peak expiratory flow as assessed by peak expiratory flow meter with a pillow face mask.

Secondary Outcomes

Percentage change in forced expiratory volume in 1 second (FEV1)(one week pre-intervention and up to 4 weeks post-intervention)
Percentage change in forced vital capacity (FVC)(one week pre-intervention and up to 4 weeks post-intervention)
Change in cough effectiveness as measured by Likert Scale(one week pre-intervention and up to 4 weeks post-intervention)
Percentage change in maximum expiratory pressure (MEP)(one week pre-intervention and up to 4 weeks post-intervention)
Percentage change in maximum inspiratory pressure (MIP)(one week pre-intervention and up to 4 weeks post-intervention)