Early ICU Standardized Rehabilitation Therapy for the Critically Injured Burn Patient
Technical Report,20 Sep 2015,19 Sep 2016
University of Kentucky Research Foundation Lexington United States
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This is a multicenter, randomized controlled trial to determine whether early ICU rehabilitation, for Burn Intensive Care Unit BICU patients will decrease hospital length of stay. 50 subjects will be randomized at each of three sites for a total of 150 subjects. The study has completed all regulatory requirements, completed site protocol developments and has begun to enroll patients. The goal enrollment minimums are an average of 2.5 patients enrolled per month, per site 7.5 patients enrolled per month, across the study. This study will increase understanding of the effect of rehabilitation on ICU Burn patients, through ultrasound and strength assessments of muscles, performed at study entry ultrasound, ICU and Hospital discharge and at 3, 6 and 12 months ultrasound and strength assessments post enrollment. Functional testing with Short Physical Performance Battery SPPB and Health Related Quality of Life HRQoL testing will determine if standardized early rehab improves functional performance, quality of life and employment status. Accomplishments Year 1 Database build, design web entry case report forms, site training finalized IRB consent forms and began enrollment, 3 subjects to date, with outpatient follow-up 3, 6, and 12 month sessions planned. Accomplishments Year 2 Active Study with enrollment of study subjects at all three sites. Completion of training of ultrasound techniques at all three sites. Out-patient follow-up has begun for those enrolled within the first year of the study.