Effect of Electrical Muscle Stimulation in Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT01637467|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : February 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Other: Electrical muscle stimulation (EMS) Other: Sham EMS||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: EMS intervention
The experimental group will received EMS at a therapeutic level.
Other: Electrical muscle stimulation (EMS)
EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
Sham Comparator: Sham
The sham group will receive EMS at a sub-therapeutic level.
Other: Sham EMS
Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
- feasibility of EMS treatment [ Time Frame: 4 weeks ]the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted
- muscle strength [ Time Frame: baseline, 2 weeks and 4 weeks ]muscle strength using manual muscle testing
- muscle thickness [ Time Frame: baseline, 2 weeks, 4 weeks ]thickness of the quadriceps muscle will be assessed using muscle ultrasound
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): NCT01637467
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Vincent Lo, BSc(PT)||University Health Network, Toronto|
|Principal Investigator:||Sunita Mathur, PhD||University of Toronto|