Status:
RECRUITING
STAT: Standard Therapy Plus Active Therapy
Lead Sponsor:
American Burn Association
Collaborating Sponsors:
United States Department of Defense
Conditions:
Burn Injury
Physical Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of the study is to assess the efficacy of STAT, an activity-based therapy protocol compared to standard therapy (ST) to improve functional outcome and reduce disability in patients recov...
Detailed Description
This investigation is a multicenter trial involving severely burned patients. The design will be a 1:1 randomized control study comparing the rehabilitation intervention described below to current sta...
Eligibility Criteria
Inclusion
- Age 18 to 65 years old
- Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn
- Potential need for a skin graft procedure determined by the local burn surgeon
- Survivable burn injury determined by the admitting local burn surgeon on admission
Exclusion
- Non-survivable burn injury determined by the admitting local burn surgeon on admission
- History of chronic renal failure requiring dialysis prior to injury
- History of developmental delay or congenital cognitive disorders
- Prior history of connective tissue disorders or autoimmune disease
- Anoxic or traumatic brain injury
- Prior history of cerebrovascular accident with residual mobility impairment
- Neurologic injury or disease-causing mobility impairment
- Prior history of leg amputation
- Non-viable leg requiring amputation on admission
- Anticipated inability to return for follow up testing after discharge
- History of a New York Heart Association (NYHA) class IV congestive heart failure
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT04368117
Start Date
October 26 2020
End Date
September 30 2025
Last Update
February 1 2024
Active Locations (7)
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1
ValleyWise Health
Phoenix, Arizona, United States, 85008
2
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, United States, 95817
3
Loyola University Medical Center
Maywood, Illinois, United States, 60153
4
Health and Hospital Corporation dba Eskenazi Health
Indianapolis, Indiana, United States, 46202