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
|Condition or disease||Intervention/treatment||Phase|
|Cervical Spinal Cord Injury||Device: AFES||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- 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.
- 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.
- 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 ]
- 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
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
|Contact: Henrik Gollee, PhD||44-141-330-4406||Henrik.firstname.lastname@example.org|
|Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital||Recruiting|
|Glasgow, United Kingdom, G51 4TF|
|Principal Investigator:||Henrik Gollee, PhD||University of Glasgow|