Health TrialsbyHealthPanel

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

ConditionAcute Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Individuals who do not meet inclusion criteria

Prisoners

Concurrent traumatic brain injury determined by Rancho level of cognitive functioning < VI

Individuals with open tracheostomy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: AFES and RMT Paraplegia GroupExperimental treatment 1 intervention
Group B: AFES and RMT Tetraplegia GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
one week pre-intervention and up to 4 weeks post-intervention
2

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.

Time frame
one week pre-intervention and up to 4 weeks post-intervention

Secondary outcomes

1

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.

Time frame
one week pre-intervention and up to 4 weeks post-intervention
2

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.

Time frame
one week pre-intervention and up to 4 weeks post-intervention
3

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.

Time frame
one week pre-intervention and up to 4 weeks post-intervention
4

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.

Time frame
one week pre-intervention and up to 4 weeks post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
Apply now