Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
166 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-26
Study Completion Date
2025-09-30
Brief Summary
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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 recovering from burn injury. This randomized multi-center trial is designed with two parallel treatment groups: STAT and ST. Efficacy of the STAT protocol will be determined through comparison to the ST only group. It will be conducted at seven burn centers.
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Detailed Description
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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 standard care in severely burned patients. This study will take place in multiple U.S. burn centers and involve adult (18 years and older) burn patient with ≥15% total body surface area (TBSA) burn who will undergo a skin graft procedure. The local burn surgeon will direct all medical and surgical treatment. The treating physician will make all clinical decisions regarding the patient.
Study Groups
Standard therapy (ST) group
Patients in the ST group will receive routine burn therapy care with no specific prescription of activities or frequency/duration of therapy. Burn therapy will begin when the patient has been medically cleared by the treating physician to begin burn therapy and when the patient undergoes surgery, therapy will halt and resume as is typical for the participating site. All burn therapy procedures will be according to what is customary and typical for the burn center. Standard therapy practices will be documented with a pre-study interview with clinicians at each participating site. Standard burn therapy typically includes interventions such as range of motion, positioning, splinting, exercise, mobilization and pressure therapy. The amount of time and types of ST interventions will be documented at the end of each session daily. Any missed or interrupted treatment time will also be documented. Post discharge home program will include what would normally be included at discharge.
Active therapy (STAT) intervention group
Patients randomized to receive STAT therapy will receive an intensive, quantifiable, activity-based protocol emphasizing four of the most active components of therapy: mobilization, strength training, aerobic training and functional training. The STAT protocol guidelines are described below. As with the ST group, STAT therapy will begin when the patient has been medically cleared by the treating physician to begin burn therapy. STAT will not be provided for any given therapy session that the patient demonstrates any of the contraindicated safety parameters defined in Table 2. When the patient undergoes surgery, the STAT protocol will be held for the day of surgery and will resume post-operative day #1 whenever possible. The STAT protocol will be implemented 30-45 minutes per day, 5 days/ per week when possible throughout the patient's care from admission until the patient is discharged from acute care with a target treatment minimum of 150 minutes per week. Over the course of a week, all four activities in the STAT protocol should be implemented when possible. Multiple activities can be addressed within one session or single activities over multiple days.
Study Groups
Standard therapy (ST) group
Patients in the ST group will receive routine burn therapy care with no specific prescription of activities or frequency/duration of therapy. Burn therapy will begin when the patient has been medically cleared by the treating physician to begin burn therapy and when the patient undergoes surgery, therapy will halt and resume as is typical for the participating site. All burn therapy procedures will be according to what is customary and typical for the burn center. Standard therapy practices will be documented with a pre-study interview with clinicians at each participating site. Standard burn therapy typically includes interventions such as range of motion, positioning, splinting, exercise, mobilization and pressure therapy. The amount of time and types of ST interventions will be documented at the end of each session daily. Any missed or interrupted treatment time will also be documented. Post discharge home program will include what would normally be included at discharge.
Active therapy (STAT) intervention group
Patients randomized to receive STAT therapy will receive an intensive, quantifiable, activity-based protocol emphasizing four of the most active components of therapy: mobilization, strength training, aerobic training and functional training. The STAT protocol guidelines are described below. As with the ST group, STAT therapy will begin when the patient has been medically cleared by the treating physician to begin burn therapy. STAT will not be provided for any given therapy session that the patient demonstrates any of the contraindicated safety parameters defined in Table 2. When the patient undergoes surgery, the STAT protocol will be held for the day of surgery and will resume post-operative day #1 whenever possible. The STAT protocol will be implemented 30-45 minutes per day, 5 days/ per week when possible throughout the patient's care from admission until the patient is discharged from acute care with a target treatment minimum of 150 minutes per week. Over the course of a week, all four activities in the STAT protocol should be implemented when possible. Multiple activities can be addressed within one session or single activities over multiple days.
Conditions
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Burn Injury
Physical Injury
Thermal Burn
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Severely burn injured with a 15% TBSA of burn injury or larger who require a skin graft surgery
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Standard Therapy (ST)
Patients randomized to the ST group will receive standard of care, routine burn physical therapy.
Group Type
ACTIVE_COMPARATOR
Physical Therapy
Intervention Type
BEHAVIORAL
Directed and prescribe physical therapy program for severely burned patients
Active Therapy (STAT)
Patients randomized to the STAT group will receive an intensive, quantifiable, activity-based physical therapy prescription emphasizing four of the most active components of therapy: mobilization, strength training, aerobic training and functional training.
Group Type
EXPERIMENTAL
Physical Therapy
Intervention Type
BEHAVIORAL
Directed and prescribe physical therapy program for severely burned patients
Interventions
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Physical Therapy
Directed and prescribe physical therapy program for severely burned patients
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Age 18 to 65 years old
2. Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn
3. Potential need for a skin graft procedure determined by the local burn surgeon
4. Survivable burn injury determined by the admitting local burn surgeon on admission
2. Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn
3. Potential need for a skin graft procedure determined by the local burn surgeon
4. Survivable burn injury determined by the admitting local burn surgeon on admission
Exclusion Criteria
1. Non-survivable burn injury determined by the admitting local burn surgeon on admission
2. History of chronic renal failure requiring dialysis prior to injury
3. History of developmental delay or congenital cognitive disorders
4. Prior history of connective tissue disorders or autoimmune disease
5. Anoxic or traumatic brain injury
6. Prior history of cerebrovascular accident with residual mobility impairment
7. Neurologic injury or disease-causing mobility impairment
8. Prior history of leg amputation
9. Non-viable leg requiring amputation on admission
10. Anticipated inability to return for follow up testing after discharge
11. History of a New York Heart Association (NYHA) class IV congestive heart failure
2. History of chronic renal failure requiring dialysis prior to injury
3. History of developmental delay or congenital cognitive disorders
4. Prior history of connective tissue disorders or autoimmune disease
5. Anoxic or traumatic brain injury
6. Prior history of cerebrovascular accident with residual mobility impairment
7. Neurologic injury or disease-causing mobility impairment
8. Prior history of leg amputation
9. Non-viable leg requiring amputation on admission
10. Anticipated inability to return for follow up testing after discharge
11. History of a New York Heart Association (NYHA) class IV congestive heart failure
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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United States Department of Defense
FED
Sponsor Role
collaborator
American Burn Association
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Soman Sen, MD
Role: PRINCIPAL_INVESTIGATOR
UC Davis
Locations
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ValleyWise Health
Phoenix, Arizona, United States
Site Status
RECRUITING
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, United States
Site Status
RECRUITING
Loyola University Medical Center
Maywood, Illinois, United States
Site Status
RECRUITING
Health and Hospital Corporation dba Eskenazi Health
Indianapolis, Indiana, United States
Site Status
RECRUITING
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Site Status
RECRUITING
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
RECRUITING
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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W81XWH-19-2-0043
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1552346
Identifier Type: -
Identifier Source: org_study_id
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