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

Not Applicable

Recruiting

• Conditions: Acute Spinal Cord Injury
• Interventions: Device: Xcite Clinical Station

• Registration Number: NCT05745298
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Study Start: 2023-07-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07-21
• Study Completion: 2025-07-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFES and RMT Paraplegia Group	Xcite Clinical Station	Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.
AFES and RMT Tetraplegia Group	Xcite Clinical Station	Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage change in peak cough flow (PCF)	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	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 Outcome Measures

Name	Time	Method
Percentage change in forced expiratory volume in 1 second (FEV1)	one week pre-intervention and up to 4 weeks post-intervention	Assessing the percentage change in forced expiratory volume in 1 second (FEV1) as measured by the spirobank II. Measured in Liters/minute.
Percentage change in forced vital capacity (FVC)	one week pre-intervention and up to 4 weeks post-intervention	Assessing the percentage change in forced vital capacity (FVC) as measured by the spirobank II. Measured in Liters/minute.
Change in cough effectiveness as measured by Likert Scale	one week pre-intervention and up to 4 weeks post-intervention	The 5-point Likert scale will be used to obtain a self-rated perception of cough effectiveness. The participant will be asked to rate how strong and how well secretions were cleared after coughing. The rating scale will range from 1=very poor; 2=poor; 3=fair, 4=good; 5= very good. A score of 4 or 5 is classified as effectively clearing secretions after coughing.
Percentage change in maximum expiratory pressure (MEP)	one week pre-intervention and up to 4 weeks post-intervention	Assessing the percentage change in maximum expiratory pressure (MEP) as measured by the MicroSpiro. Measured in Liters/minute.
Percentage change in maximum inspiratory pressure (MIP)	one week pre-intervention and up to 4 weeks post-intervention	Assessing the percentage change in maximum inspiratory pressure (MIP) as measured by the MicroSpiro. Measured in Liters/minute.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States