Back to resultsThe Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury (AFES and RMT)
Primary Purpose
Acute Spinal Cord Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xcite Clinical Station
Sponsored by
About this trial
This is an interventional treatment trial for Acute Spinal Cord Injury
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
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AFES and RMT Paraplegia Group
AFES and RMT Tetraplegia Group
Arm Description
Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.
Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05745298
Brief Title
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
Acronym
AFES and RMT
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
July 21, 2025 (Anticipated)
Study Completion Date
July 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AFES and RMT Paraplegia Group
Arm Type
Experimental
Arm Description
Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.
Arm Title
AFES and RMT Tetraplegia Group
Arm Type
Experimental
Arm Description
Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Xcite Clinical Station
Intervention Description
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 Measure Information:
Title
Percentage change in peak cough flow (PCF)
Description
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
Title
Percentage change in peak expiratory flow
Description
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 Outcome Measure Information:
Title
Percentage change in forced expiratory volume in 1 second (FEV1)
Description
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
Title
Percentage change in forced vital capacity (FVC)
Description
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
Title
Percentage change in maximum inspiratory pressure (MIP)
Description
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
Title
Percentage change in maximum expiratory pressure (MEP)
Description
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
Title
Change in cough effectiveness as measured by Likert Scale
Description
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.
Time Frame
one week pre-intervention and up to 4 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary J Farkas, PhD
Phone
305-243-4518
Email
gjf50@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Philippe-Ratway, MS, CCC-SLP
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary J Farkas, PhD
Phone
305-243-4518
Email
gjf50@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Stephane stephane.philippera@jhsmiami.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
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