STAT: Standard Therapy Plus Active Therapy

NCT04368117 | Unknown DMC

• 2 other identifiers: 1552346W81XWH-19-2-0043
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 7

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.

Conditions

Burn Injury; Physical Injury; Thermal Burn

Keywords

Physical impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Long-term physical activity-functional task upper extremities

  3.5 years

• Long-term physical activity- functional task lower extremities

  3.5 years

• Long-term physical activity- daily steps

  3.5 years

• Long-term physical activity- daily distance walked

  3.5 years

• Long-term physical activity- calories used

  3.5 years

Other Outcomes (11)

• Time from hospital discharge to Return to Work status

  3.5 years

• Time from hospital discharge to Return to Active Duty

  3.5 years

• Quality of Life - Performance of Self Care Activities of Daily Living

  3.5 years

Study Arms (2)

Standard Therapy (ST)

ACTIVE COMPARATOR

Patients randomized to the ST group will receive standard of care, routine burn physical therapy.

Behavioral: Physical Therapy

Active Therapy (STAT)

EXPERIMENTAL

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

Interventions

Physical Therapy BEHAVIORAL

Directed and prescribe physical therapy program for severely burned patients

Active Therapy (STAT); Standard Therapy (ST)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Burn Association: lead
• United States Department of Defense: collaborator

Study Sites (7)

ValleyWise Health

Phoenix, Arizona, 85008, United States

RECRUITING

University of California Davis Medical Center-Regional Burn Center

Sacramento, California, 95817, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Health and Hospital Corporation dba Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

RECRUITING

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MeSH Terms

Conditions

Burns

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Soman Sen, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Falwell, BSN RN

CONTACT

916-453-2134; kafalwell@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Severely burn injured with a 15% TBSA of burn injury or larger who require a skin graft surgery

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 29, 2020
• Study Start: October 26, 2020
• Primary Completion: August 1, 2025
• Study Completion: September 30, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (7)