Acute Spinal Cord InjuryAFES and RMTNCT05745298
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
A study testing Xcite Clinical Station in people with Acute Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- Xcite Clinical Station
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 21 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Gary J Farkas, PhD, 3052434518, gjf50@med.miami.edu
Stephane stephane.philippera@jhsmiami.org
About this study
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.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- Xcite Clinical Station
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xcite Clinical StationDevice
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 group | Role | What they receive |
|---|---|---|
| AFES and RMT Paraplegia Group | Experimental | Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks. Receives: Device: Xcite Clinical Station |
| AFES and RMT Tetraplegia Group | Experimental | Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks. Receives: Device: Xcite Clinical Station |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one week pre-intervention and up to 4 weeks post-intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one week pre-intervention and up to 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start21 Jul 2023
- Primary completion21 Jul 2028 (estimated)
- Study completion21 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Philippe-ratway, University of Miami
- Investigators
- Stephane Philippe-Ratway, MS, CCC-SLP, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745298
- Sponsor's protocol ID
- 20221081
- Acronym
- AFES and RMT
- Status last verified
- Jul 2026
- First submitted
- 16 Feb 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT05745298
- Acronym / sponsor ID
- AFES and RMT / 20221081
- Conditions
- Acute Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 21 Jul 2028 (estimated)
- Study completion
- 21 Sep 2028 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AFES and RMT Paraplegia Group | Experimental | Device: Xcite Clinical StationPatients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks. |
| AFES and RMT Tetraplegia Group | Experimental | Device: Xcite Clinical StationPatients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xcite Clinical StationThe 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. | Device | AFES and RMT Paraplegia Group, AFES and RMT Tetraplegia Group |
Primary outcome
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.
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.
5 secondary outcomes
Percentage change in forced expiratory volume in 1 second (FEV1)
Time frame: one week pre-intervention and up to 4 weeks post-intervention
Percentage change in forced vital capacity (FVC)
Time frame: one week pre-intervention and up to 4 weeks post-intervention
Percentage change in maximum inspiratory pressure (MIP)
Time frame: one week pre-intervention and up to 4 weeks post-intervention
Percentage change in maximum expiratory pressure (MEP)
Time frame: one week pre-intervention and up to 4 weeks post-intervention
Change in cough effectiveness as measured by Likert Scale
Time frame: one week pre-intervention and up to 4 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephane Philippe-Ratway, MS, CCC-SLP principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xcite Clinical Station in people with Acute Spinal Cord Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gary J Farkas, PhD (305-243-4518, gjf50@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in peak cough flow (PCF) (time frame: one week pre-intervention and up to 4 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.