STAT: Standard Therapy Plus Active Therapy (STAT)

January 31, 2024 updated by: American Burn Association

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Medical Center-Regional Burn Center
        • Contact:
        • Principal Investigator:
          • Soman Sen, MD
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Anthony Baldea, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Health and Hospital Corporation dba Eskenazi Health
        • Contact:
        • Principal Investigator:
          • Rajiv Sood, MD
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins Bayview Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Scott Vocke, DPT
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • James Holmes, MD
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Recruiting
        • United States Army Institute of Surgical Research
        • Contact:
        • Principal Investigator:
          • Leopoldo Cancio, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3.5 years
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.
3.5 years
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
3.5 years
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
3.5 years
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
3.5 years
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
3.5 years
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
3.5 years
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
3.5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3.5 years
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.
3.5 years
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.
3.5 years
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.
3.5 years
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.
3.5 years
Incidence of cardiovascular complications
Time Frame: 3.5 years
The incidence of cardiovascular complications will be measured in both groups.
3.5 years
Total Ventilator days
Time Frame: 3.5 years
The number of ventilator days will be measured in both groups.
3.5 years
Total number of infections
Time Frame: 3.5 years
The number of infections will be measured in both groups.
3.5 years
Hospital length of stay
Time Frame: 3.5 years
Total number of hospital days will be measured in both groups.
3.5 years
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.
3.5 years
Incidence of post surgical complications
Time Frame: 3.5 years
The incidence of patients requiring repeat-skin graft procedures will be compared between groups
3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Burn Association

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Soman Sen, MD, UC Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1552346
  • W81XWH-19-2-0043 (Other Grant/Funding Number: US Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be made available to researchers through the Burn Science Advisory Panel of the American Burn Association

IPD Sharing Time Frame

The data will be come available 1 year after completion of study analysis and publication of initial study findings

IPD Sharing Access Criteria

Clinical researcher with approval of use from the Burn Science Advisory Panel of the American Burn Association

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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