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NCT Number: NCT05745298

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

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.

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Key information

Conditions

Acute Spinal Cord Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Prisoners
  • 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

Treatment and study plan

Xcite Clinical Station

Device

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.

Primary outcomes

  1. 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.

  2. 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

  1. Percentage change in forced expiratory volume in 1 second (FEV1)

    Time frame: 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.

  2. Percentage change in forced vital capacity (FVC)

    Time frame: 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.

  3. Percentage change in maximum inspiratory pressure (MIP)

    Time frame: 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.

  4. Percentage change in maximum expiratory pressure (MEP)

    Time frame: 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.

  5. Change in cough effectiveness as measured by Likert Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gary J Farkas, PhD

CONTACT

[email protected]

305-243-4518

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: AFES and RMT

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 27, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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