About this trial
The goal of this clinical trial is to learn if abdominal functional electrical stimulation (FES) using the VentFree Respiratory Muscle Stimulator improves cough strength in adults with a new spinal cord injury (SCI). It will also learn about the safety of abdominal FES in this population. The main questions it aims to answer are:
Does abdominal FES improve cough peak flow (a measure of cough strength) compared to cough training alone? Does abdominal FES reduce the number of respiratory complications (such as pneumonia or atelectasis)? What medical problems do participants have when receiving abdominal FES?
Researchers will compare abdominal FES (active treatment) to supervised cough training without stimulation (control) to see if abdominal FES improves cough function after spinal cord injury.
Participants will:
Receive abdominal FES or perform supervised cough training 5 days per week for up to 6 weeks during inpatient rehabilitation Have cough strength and breathing function measured at the start of the study and every week during treatment Complete quality of life and bowel function questionnaires at multiple time points Have a follow-up visit or phone call 4 weeks after completing treatment
Eligibility criteria
Qualifiers
Adults (≥ 22 years of age) admitted to rehabilitation with a new SCI.
New non-progressive SCI occurring in the past 3 to 8 weeks.
Neurological level of injury of C1-T5.
American Spinal Injuries Association Impairment Scale A to C.
Disqualifiers
Respiratory complications in previous 24 hours (screening out iatrogenic complications).
Chronic respiratory disease.
No contraction of the abdominal wall muscles in response to abdominal NMES.
Open abdominal surgery ≤ 4 weeks prior to enrollment.
Trial design
Treatments tested in this trial
- Respiratory Muscle Stimulator
- Supervised Cough Training
Treatment groups
Locations
Sponsors and collaborators
Liberate Medical
Lead sponsor
United States Department of Defense
Collaborator