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Abdominal Functional Electrical Stimulation Training and Its Effect on Mechanical Insufflation-Exsufflation

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ClinicalTrials.gov Identifier: NCT01800409
Recruitment Status : Unknown
Verified February 2013 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : February 27, 2013
Last Update Posted : February 28, 2013
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
Compromised respiratory function as a result of tetraplegia is a leading cause of rehospitalisation for the tetraplegic patient group. Electrical stimulation of the abdominal muscles has previously been used to improve the respiratory function of tetraplegic patients in the chronic stage of injury. In this study the investigators aim to evaluate the optimum protocol for the use of electrical stimulation of the abdominal muscles to improve the respiratory function of the tetraplegic population. The investigators also aim to investigate whether abdominal functional electrical stimulation combined with mechanical insufflation-exsufflation can be used to help further improve the respiratory function of the tetraplegic population.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Device: AFES Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Abdominal Functional Electrical Stimulation Training and Its Effect on Mechanical Insufflation-Exsufflation
Study Start Date : February 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: AFES training
Participants will take part in AFES training sessions five times per week (Mon-Fri) for a total of 8 weeks During these sessions participants will receive AFES for 40 minutes. Training sessions are designed to strengthen the participants abdominal muscles in order to improve respiratory function
Device: AFES
During the stimulation sessions electrical stimulation will be applied for 40 minutes per day, 5 days per week for a total of 8 weeks
Other Name: neuromuscular stimulator (RehaStim, HasoMed, Germany)

No Intervention: Control period
Four week control period. The order of the control and training periods will be randomised for each participant.



Primary Outcome Measures :
  1. Respiratory function [ Time Frame: at end of 8 week AFES intervention ]
    Forced Vital Capacity (FVC) tests will be performed with and without abdominal stimulation, which provides a measure of the participant's Vital Capacity (VC), Forced Exhaled Volume in one second (FEV1) and Peak Expiratory Flow (PEF). Respiratory flow and volume will be measured using a spirometer.


Secondary Outcome Measures :
  1. the total excursion of the diaphragm under both stimulated and unstimulated conditions [ Time Frame: at end of 8 week AFES intervention ]
    The movement of the diaphragm will be measured during a FVC manoeuvre using an ultrasound probe, with and without AFES assistance.

  2. the cough peak flow generated through unassisted MI-E, manually-assisted MI-E and AFES-assisted MI-E [ Time Frame: at end of 8 week AFES intervention ]
  3. Patient's experience of using MI-E combined with AFES compared to the use of clinically established techniques [ Time Frame: at end of 8 week AFES intervention ]
    Participants will be asked whether they prefer MI-E with AFES to MI-E with and without a manually assisted cough and whether they find the use of AFES more effective than the other techniques



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women over 16 years of age
  • Reduced respiratory function as a result of a cervical spinal cord injury
  • Good visual response to surface abdominal stimulation, suggesting that lower motor neurons are intact
  • Ventilator independent

Exclusion Criteria:

  • Under 16 years of age
  • Female subjects who are pregnant
  • Significant history of autonomic dysreflexia
  • No visual response to surface abdominal stimulation, suggesting that lower motor neurons are not intact
  • Unstable chest or abdominal injury
  • High levels of intrinsic PEEP (bulleous disease, lung tumour etc)
  • High anastomosis (e.g. oesophago-gastrectomy)
  • Bulbar dysfunction
  • Unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800409


Contacts
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Contact: Henrik Gollee, PhD 44-141-330-4406 Henrik.gollee@glasgow.ac.uk

Locations
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United Kingdom
Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Henrik Gollee, PhD University of Glasgow

Publications:

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01800409     History of Changes
Other Study ID Numbers: GN12NE539
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013
Keywords provided by NHS Greater Glasgow and Clyde:
Tetraplegia
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries