NCT04368117

STAT: Standard Therapy Plus Active Therapy

Study Contact:

Katrina Falwell, BSN RN - Role: CONTACT - Phone: 916-453-2134 - Email: kafalwell@ucdavis.edu

Study Phase:

Recruitment Status:

RECRUITING

NCT ID:

NCT04368117

Principal Investigator:

Study Type:

INTERVENTIONAL

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Burn Injury

Physical Injury

Thermal Burn

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BEHAVIORAL
- Name: Physical Therapy
- Description: Directed and prescribe physical therapy program for severely burned patients
- Arm Group Labels: Active Therapy (STAT), Standard Therapy (ST)

Sponsor

American Burn Association