STAT: Standard Therapy Plus Active Therapy

Study Overview
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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.

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.

Official Title
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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

Conditions
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Burn Injury, Physical Injury, Thermal Burn

Intervention / Treatment
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* Behavioral: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Severely burn injured with a 15% TBSA of burn injury or larger who require a skin graft surgery
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy (ST)<br>Patients randomized to the ST group will receive standard of care, routine burn physical therapy. | Behavioral: Physical Therapy<br>* Directed and prescribe physical therapy program for severely burned patients<br>|
| Experimental: Active Therapy (STAT)<br>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<br>* Directed and prescribe physical therapy program for severely burned patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term physical activity-functional task upper extremities | 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. | 3.5 years | 
| Long-term physical activity- functional task lower extremities | 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. | 3.5 years | 
| Long-term physical activity- daily steps | Total daily steps taken will be measured using a wearable monitor in both STAT and ST | 3.5 years | 
| Long-term physical activity- daily distance walked | Daily distance walked will be measured using a wearable monitor in both STAT and ST | 3.5 years | 
| Long-term physical activity- calories used | Daily calories used will be measured using a wearable monitor in both STAT and ST | 3.5 years | 
| Long-term physical activity-gait quality- speed of walking | Gait parameters such as speed will be measured using the GAITrite® Platinum Plus System 14' with Logitech® Camera | 3.5 years | 
| Long-term physical activity-gait quality- cadence of steps | Gait parameters such as cadence will be measured using the GAITrite® Platinum Plus System 14' with Logitech® Camera | 3.5 years | 
| Long-term physical activity-gait quality-length of stride when walking | Gait parameters such as stride length will be measured using the GAITrite® Platinum Plus System 14' with Logitech® Camera | 3.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical impairment