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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Spinal Cord Injury
• Intervention / Treatment: Device: Xcite Clinical Station

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gary J Farkas, PhD; Phone Number: 305-243-4518; Email: gjf50@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Gary J Farkas, PhD; Phone Number: 305-243-4518; Email: gjf50@med.miami.edu
      • Principal Investigator: Stephane stephane.philippera@jhsmiami.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AFES and RMT Paraplegia Group; Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.	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.
Experimental: AFES and RMT Tetraplegia Group; Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Stephane Philippe-Ratway, MS, CCC-SLP, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Estimated): July 21, 2027
• Study Completion (Estimated): September 21, 2027

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 20221081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No