STAT: Standard Therapy Plus Active Therapy

Burn Injury Clinical Trial

— STAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368117
• Other study ID #: 1552346
• Secondary ID: W81XWH-19-2-0043
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: American Burn Association
• Contact: Katrina Falwell, BSN RN
• Phone: 916-453-2134
• Email: kafalwell[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: September 30, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Physical Injury
• Thermal Burn
• Wounds and Injuries

Intervention

Behavioral:
• Physical Therapy
Directed and prescribe physical therapy program for severely burned patients

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	United States Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	Health and Hospital Corporation dba Eskenazi Health	Indianapolis	Indiana
United States	Loyola University Medical Center	Maywood	Illinois
United States	ValleyWise Health	Phoenix	Arizona
United States	University of California Davis Medical Center-Regional Burn Center	Sacramento	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
American Burn Association	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from hospital discharge to Return to Work status	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
Other	Time from hospital discharge to Return to Active Duty	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
Other	Quality of Life - Performance of Self Care Activities of Daily Living	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
Other	Quality of Life - Performance of Leisure Activities	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
Other	Quality of Life - Patient reported productivity after burn injury	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
Other	Incidence of cardiovascular complications	The incidence of cardiovascular complications will be measured in both groups.	3.5 years
Other	Total Ventilator days	The number of ventilator days will be measured in both groups.	3.5 years
Other	Total number of infections	The number of infections will be measured in both groups.	3.5 years
Other	Hospital length of stay	Total number of hospital days will be measured in both groups.	3.5 years
Other	Quality of Life Assessment: Burn Specific Health Scale (BSHS)	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
Other	Incidence of post surgical complications	The incidence of patients requiring repeat-skin graft procedures will be compared between groups	3.5 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Long-term physical activity- calories used	Daily calories used will be measured using a wearable monitor in both STAT and ST	3.5 years
Secondary	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
Secondary	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
Secondary	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