Acute Spinal Cord Injury
Conditions
Brief 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.
Interventions
DEVICEXcite 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.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Positive response to electrical stimulation through a palpable contraction 3. Fluent in written and spoken English
Exclusion criteria
1. Individuals who do not meet inclusion criteria 2. Prisoners 3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI 4. Individuals with open tracheostomy 5. Persons with pacemakers 6. Pregnant women 7. Persons with epilepsy 8. Open wounds or metal implants at site of electrode placement 9. Unresponsive to functional electrical stimulation 10. Current diagnosis or history of thoraco-abdomino-pelvic cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in peak cough flow (PCF) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in forced expiratory volume in 1 second (FEV1) | one week pre-intervention and up to 4 weeks post-intervention | Assessing the percentage change in forced expiratory volume in 1 second (FEV1) as measured by the spirobank II. Measured in Liters/minute. |
| Percentage change in forced vital capacity (FVC) | one week pre-intervention and up to 4 weeks post-intervention | Assessing the percentage change in forced vital capacity (FVC) as measured by the spirobank II. Measured in Liters/minute. |
| Percentage change in maximum inspiratory pressure (MIP) | one week pre-intervention and up to 4 weeks post-intervention | Assessing the percentage change in maximum inspiratory pressure (MIP) as measured by the MicroSpiro. Measured in Liters/minute. |
| Percentage change in maximum expiratory pressure (MEP) | one week pre-intervention and up to 4 weeks post-intervention | Assessing the percentage change in maximum expiratory pressure (MEP) as measured by the MicroSpiro. Measured in Liters/minute. |
| Change in cough effectiveness as measured by Likert Scale | one week pre-intervention and up to 4 weeks post-intervention | 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. |
Countries
United States
Contacts
CONTACTGary J Farkas, PhD
PRINCIPAL_INVESTIGATORStephane Philippe-Ratway, MS, CCC-SLP
University of Miami
Outcome results
None listed