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Electrical Stimulation

Functional Electrical Stimulation + Respiratory Muscle Training for Spinal Cord Injury (AFES and RMT Trial)

N/A

Recruiting

Led By Lawrence P Cahalin, PhD, PT

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive response to electrical stimulation through a palpable contraction

Fluent in written and spoken English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one week pre-intervention and up to 4 weeks post-intervention

Awards & highlights

AFES and RMT Trial Summary

This trial aims to use electrical stimulation & muscle training to help spinal cord injury patients cough more effectively.

Who is the study for?

This trial is for individuals with acute spinal cord injuries (C2-T12 level, AIS A-C) who are in rehab and were injured less than a year ago. They must respond to electrical stimulation and speak English. It's not for those with severe brain injury, open tracheostomy, pacemakers, pregnancy, epilepsy, wounds or metal at the electrode site, unresponsiveness to electrical stimulation or history of certain cancers.Check my eligibility

What is being tested?

The study tests if using the Xcite Clinical Station—electrical stimulation on abdominal and latissimus dorsi muscles combined with respiratory muscle training—can improve coughing ability in people with recent spinal cord injuries.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, muscle fatigue from training sessions, skin irritation from electrodes placement. The procedure is generally safe but individual reactions can vary.

AFES and RMT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My muscles respond to electrical stimulation with a visible contraction.

Select...

I am fluent in both written and spoken English.

AFES and RMT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week pre-intervention and up to 4 weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week pre-intervention and up to 4 weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week pre-intervention and up to 4 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage change in peak cough flow (PCF)

Percentage change in peak expiratory flow

Secondary outcome measures

Change in cough effectiveness as measured by Likert Scale

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

Percentage change in forced vital capacity (FVC)

+2 more

AFES and RMT Trial Design

2Treatment groups

Experimental Treatment

Group I: AFES and RMT Tetraplegia GroupExperimental Treatment1 Intervention

Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.

Group II: AFES and RMT Paraplegia GroupExperimental Treatment1 Intervention

Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

902 Previous Clinical Trials

410,026 Total Patients Enrolled

Lawrence P Cahalin, PhD, PTPrincipal InvestigatorUniversity of Miami

Stephane Philippe-Ratway, MS, CCC-SLPPrincipal InvestigatorUniversity of Miami

Media Library

Xcite Clinical Station (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05745298 — N/A

Spinal Cord Injury Research Study Groups: AFES and RMT Paraplegia Group, AFES and RMT Tetraplegia Group

Spinal Cord Injury Clinical Trial 2023: Xcite Clinical Station Highlights & Side Effects. Trial Name: NCT05745298 — N/A

Xcite Clinical Station (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05745298 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of this clinical trial?

"This trial's primary outcome, assessed over the predetermined period of one week prior to and four weeks post-intervention, is the Percentage change in peak expiratory flow. Secondary objectives include measuring Percentage changes in forced vital capacity (FVC) and maximum inspiratory pressure (MIP), as well as assessing Maximum Expiratory Pressure (MEP). All measurements will be taken with a MicroSpiro device and expressed in Liters/minute."

Answered by AI

Are there current opportunities for patients to sign up for this research study?

"According to clinicaltrials.gov, this specific medical study is not presently enrolling patients; its first posting was on April 3rd 2023 and the last update occurred February 16th of that same year. Notwithstanding, there are currently 916 other trials actively calling for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stephane Philippe-ratway 2023. "The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05745298.