Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Phoenix, Arizona and other locations
Dates
study started
estimated completion
Principal Investigator
Soman Sen, MD

Description

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.

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

Details

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.

Keywords

Burn Injury Physical Injury Thermal Burn Physical impairment Burns Wounds and Injuries Physical Therapy

Eligibility

You can join if…

Open to people ages 18-65

  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

You CAN'T join if...

  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

Locations

  • ValleyWise Health
    Phoenix Arizona 85008 United States
  • United States Army Institute of Surgical Research
    Fort Sam Houston Texas 78234 United States

Lead Scientist at UC Davis

  • Soman Sen, MD
    Associate Professor, Surgery. Authored (or co-authored) 72 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
American Burn Association
Links
Sign up for this study
ID
NCT04368117
Study Type
Interventional
Last Updated