NCT05745298

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jul 2023Sep 2027

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2027

Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

February 16, 2023

Last Update Submit

July 3, 2025

Conditions

Acute Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Percentage change in forced expiratory volume in 1 second (FEV1)

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

  • Percentage change in forced vital capacity (FVC)

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

  • Percentage change in maximum inspiratory pressure (MIP)

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

  • Percentage change in maximum expiratory pressure (MEP)

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

  • Change in cough effectiveness as measured by Likert Scale

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

Study Arms (2)

AFES and RMT Paraplegia Group

EXPERIMENTAL

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

AFES and RMT Tetraplegia Group

EXPERIMENTAL

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

Interventions

Xcite Clinical StationDEVICE

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.

AFES and RMT Paraplegia GroupAFES and RMT Tetraplegia Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Study Officials

  • Stephane Philippe-Ratway, MS, CCC-SLP

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary J Farkas, PhD

CONTACT

305-243-4518gjf50@med.miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speech Pathologist

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

July 21, 2023

Primary Completion (Estimated)

July 21, 2027

Study Completion (Estimated)

September 21, 2027

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)