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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Spinal Cord Injury

Intervention / Treatment
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* Device: Xcite Clinical Station


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFES and RMT Paraplegia Group<br>Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks. | Device: Xcite Clinical Station<br>* 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.<br>|
| Experimental: AFES and RMT Tetraplegia Group<br>Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks. | Device: Xcite Clinical Station<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | one week pre-intervention and up to 4 weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | one week pre-intervention and up to 4 weeks post-intervention |