Recruiting NCT05745298
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xcite Clinical Station.
- Who it may be relevant to
- Registry conditions: Acute Spinal Cord Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Xcite Clinical Station
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.
Primary outcome measures
- Percentage change in peak cough flow (PCF) [Time frame: one week pre-intervention and up to 4 weeks post-intervention]
- Percentage change in peak expiratory flow [Time frame: one week pre-intervention and up to 4 weeks post-intervention]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT05745298 · 20221081