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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05745298
Status
Recruiting
Apply to this trial

Conditions

  • Acute Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 21, 2023
Status verified
Jul 2025
Primary completion
Jul 21, 2027
Completion
Sep 21, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Percentage change in peak cough flow (PCF) [ Time Frame: one week pre-intervention and up to 4 weeks post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Gary J Farkas, PhD
[email protected]
305-243-4518
Stephane [email protected] (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FL

Related Studies