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

Acute Spinal Cord Injury Clinical Trial

— AFES and RMT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05745298
• Other study ID #: 20221081
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: July 21, 2025

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: Gary J Farkas, PhD
• Phone: 305-243-4518
• Email: gjf50[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 21, 2025
• Est. primary completion date: July 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Xcite Clinical Station
The abdominal functional electrical stimulation (AFES) will be conducted using the Xcite system. This is a battery-powered stimulator with up to 12 channels of cyclical stimulation. It is a task-specific modality to enhance mass practice during neurological re-education. The electrical stimulation will be applied to the abdominal and back muscles. In addition, participants will receive two specific respiratory muscle training exercises performed 3 days per week.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in peak cough flow (PCF)	Assessing the percentage change in peak cough flow as assessed by peak expiratory flow meter with a pillow face mask.	one week pre-intervention and up to 4 weeks post-intervention
Primary	Percentage change in peak expiratory flow	Assessing the percentage change in peak expiratory flow as assessed by peak expiratory flow meter with a pillow face mask.	one week pre-intervention and up to 4 weeks post-intervention
Secondary	Percentage change in forced expiratory volume in 1 second (FEV1)	Assessing the percentage change in forced expiratory volume in 1 second (FEV1) as measured by the spirobank II. Measured in Liters/minute.	one week pre-intervention and up to 4 weeks post-intervention
Secondary	Percentage change in forced vital capacity (FVC)	Assessing the percentage change in forced vital capacity (FVC) as measured by the spirobank II. Measured in Liters/minute.	one week pre-intervention and up to 4 weeks post-intervention
Secondary	Percentage change in maximum inspiratory pressure (MIP)	Assessing the percentage change in maximum inspiratory pressure (MIP) as measured by the MicroSpiro. Measured in Liters/minute.	one week pre-intervention and up to 4 weeks post-intervention
Secondary	Percentage change in maximum expiratory pressure (MEP)	Assessing the percentage change in maximum expiratory pressure (MEP) as measured by the MicroSpiro. Measured in Liters/minute.	one week pre-intervention and up to 4 weeks post-intervention
Secondary	Change in cough effectiveness as measured by Likert Scale	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.	one week pre-intervention and up to 4 weeks post-intervention