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STAT: Standard Therapy Plus Active Therapy (STAT)

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ClinicalTrials.gov Identifier: NCT04368117
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
American Burn Association

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 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.

Condition or disease Intervention/treatment Phase
Burn Injury Physical Injury Thermal Burn Behavioral: Physical Therapy Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Severely burn injured with a 15% TBSA of burn injury or larger who require a skin graft surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STAT: Standard Therapy Plus Active Therapy to Improve Mobility, Long-Term Activity, and Quality of Life for Severely Burn Injured Patients After Skin Graft Surgery
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Therapy (ST)
Patients randomized to the ST group will receive standard of care, routine burn physical therapy.
Behavioral: Physical Therapy
Directed and prescribe physical therapy program for severely burned patients

Experimental: 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.
Behavioral: Physical Therapy
Directed and prescribe physical therapy program for severely burned patients




Primary Outcome Measures :
  1. Functional exercise capacity [ Time Frame: 3 years ]
    Functional exercise capacity will be determined using the 6-minute walk test (6MWT). Aerobic capacity is the primary outcome measure of this study because it evaluates the global and integrated responses of all of the systems involved in exercise (pulmonary, cardiovascular, circulatory, neuromuscular). The score of the test is the distance a patient walks in 6 minutes. Longer distance is associated with a better outcome.


Secondary Outcome Measures :
  1. Long-term physical activity-functional task upper extremities [ Time Frame: 3.5 years ]
    The Quick-Disabilities Assessment of the Shoulder and Hand (QuickDASH) is a questionnaire consisting of an 11-item disability/symptom scale to measure upper limb function. Score ranges from 0 (no disability) to 100 (most severe disability), so lower score associated with better outcome.

  2. Long-term physical activity- functional task lower extremities [ Time Frame: 3.5 years ]
    Lower limb function rated on a 5 point performance scale using the Higher Mobility Assessment Tool (HiMAT) Score range is from 0 to 54, with the higher score indicating better outcome.

  3. Long-term physical activity- daily steps [ Time Frame: 3.5 years ]
    Total daily steps taken will be measured using a wearable monitor in both STAT and ST

  4. Long-term physical activity- daily distance walked [ Time Frame: 3.5 years ]
    Daily distance walked will be measured using a wearable monitor in both STAT and ST

  5. Long-term physical activity- calories used [ Time Frame: 3.5 years ]
    Daily calories used will be measured using a wearable monitor in both STAT and ST

  6. Long-term physical activity-gait quality- speed of walking [ Time Frame: 3.5 years ]
    Gait parameters such as speed will be measured using the GAITrite® Platinum Plus System 14' with Logitech® Camera

  7. Long-term physical activity-gait quality- cadence of steps [ Time Frame: 3.5 years ]
    Gait parameters such as cadence will be measured using the GAITrite® Platinum Plus System 14' with Logitech® Camera

  8. Long-term physical activity-gait quality-length of stride when walking [ Time Frame: 3.5 years ]
    Gait parameters such as stride length will be measured using the GAITrite® Platinum Plus System 14' with Logitech® Camera


Other Outcome Measures:
  1. Time from hospital discharge to Return to Work status [ Time Frame: 3.5 years ]
    Data will be collected for both the STAT and ST group regarding number of days from hospital discharge to returning to work

  2. Time from hospital discharge to Return to Active Duty [ Time Frame: 3.5 years ]
    Data will be collected for both the STAT and ST group regarding number of days from hospital discharge to return to active duty status after burn injury.

  3. Quality of Life - Performance of Self Care Activities of Daily Living [ Time Frame: 3.5 years ]
    Data will be collected for both the STAT and ST group regarding patient reported performance of self care daily activities after burn injury, as measured by the Canadian Occupational Performance Measure (COPM). Range of score from 1-10 with 10 indicating better outcome.

  4. Quality of Life - Performance of Leisure Activities [ Time Frame: 3.5 years ]
    Data will be collected for both the STAT and ST regarding patient reported performance of leisure activities after burn injury, as measured by the Canadian Occupational Performance Measure (COPM). Range of score from 1-10 with 10 indicating better outcome.

  5. Quality of Life - Patient reported productivity after burn injury [ Time Frame: 3.5 years ]
    Data will be collected for both the STAT and ST regarding patient reported productivity after burn injury, as measured by the Canadian Occupational Performance Measure (COPM). Range of score from 1-10 with 10 indicating better outcome.

  6. Incidence of cardiovascular complications [ Time Frame: 3.5 years ]
    The incidence of cardiovascular complications will be measured in both groups.

  7. Total Ventilator days [ Time Frame: 3.5 years ]
    The number of ventilator days will be measured in both groups.

  8. Total number of infections [ Time Frame: 3.5 years ]
    The number of infections will be measured in both groups.

  9. Hospital length of stay [ Time Frame: 3.5 years ]
    Total number of hospital days will be measured in both groups.

  10. Quality of Life Assessment: Burn Specific Health Scale (BSHS) [ Time Frame: 3.5 years ]
    Burn Specific Health Scale (BSHS): The BSHS is a self-reported assessment of overall quality of life. It incorporates four overall areas that are specific for burn patients: affect and relationships, physical function, skin involvement, and work. ) Consists of 40 questions, each with score ranging from 0-4 and higher scores are associated with better outcomes.

  11. Incidence of post surgical complications [ Time Frame: 3.5 years ]
    The incidence of patients requiring repeat-skin graft procedures will be compared between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

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): NCT04368117


Contacts
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Contact: Katrina Falwell, BSN RN 916-453-2134 kafalwell@ucdavis.edu
Contact: Lynda Painting, BS 916-453-5085 lpainting@ucdavis.edu

Locations
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United States, Arizona
ValleyWise Health
Phoenix, Arizona, United States, 85008
Contact: Karen Richey, RN, BSN       Karen.Richey2@valleywisehealth.org   
Principal Investigator: Kevin Foster, MD         
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Principal Investigator: Anthony Baldea, MD         
United States, Indiana
Health and Hospital Corporation dba Eskenazi Health
Indianapolis, Indiana, United States, 46202
Contact: David Roggy       david.roggy@eskenazihealth.edu   
Principal Investigator: Rajiv Sood, MD         
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Contact: Brittany Christensen       blchrist@wakehealth.edu   
Principal Investigator: James Holmes, MD         
United States, Texas
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Contact: Melody Vargus       melody.s.vargus.ctr@mail.mil   
Principal Investigator: Leopoldo Cancio, MD         
Sponsors and Collaborators
American Burn Association
United States Department of Defense
Investigators
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Principal Investigator: Soman Sen, MD UC Davis
Publications:

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Responsible Party: American Burn Association
ClinicalTrials.gov Identifier: NCT04368117    
Other Study ID Numbers: 1552346
W81XWH-19-2-0043 ( Other Grant/Funding Number: US Department of Defense )
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be made available to researchers through the Burn Science Advisory Panel of the American Burn Association
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will be come available 1 year after completion of study analysis and publication of initial study findings
Access Criteria: Clinical researcher with approval of use from the Burn Science Advisory Panel of the American Burn Association

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American Burn Association:
Physical impairment
Additional relevant MeSH terms:
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Wounds and Injuries
Burns