Physical Therapy for Burns

(STAT Trial)

Recruiting at 6 trial locations

Overseen By Katrina Falwell, BSN RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: American Burn Association

Disqualifiers: Renal failure, Cognitive disorders, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: Varies until discharge

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new physical therapy approach called STAT to aid recovery from burn injuries. It compares STAT, which includes more intense exercises like strength and aerobic training, to standard therapy. The study aims to determine if STAT can improve patient function and reduce disability. Eligible participants have serious burn injuries covering at least 15% of their body and may require a skin graft. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery for future burn patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that physical therapy, such as the intensive STAT program, is generally safe for individuals recovering from burns. Studies have found that physical and occupational therapy can improve movement and strength after burn injuries.

Although specific data on side effects for STAT therapy is not available, physical therapy is recognized as safe for burn recovery. Rehabilitation commonly focuses on exercises involving movement and strength building, designed to help burn survivors regain mobility.

Overall, despite the lack of specific safety data for STAT, existing research supports the safety and benefits of physical therapy in burn recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the physical therapy approach for burn recovery because it offers a more intensive and targeted regimen than the standard care. The experimental therapy, known as STAT, emphasizes four key components: mobilization, strength training, aerobic training, and functional training, which are tailored to boost recovery speed and effectiveness. This approach aims to enhance physical rehabilitation by quantifying activity levels and focusing on active recovery methods, potentially leading to better outcomes compared to traditional routine therapy.

What evidence suggests that this trial's treatments could be effective for burn recovery?

Research has shown that intensive physical therapy, such as the STAT program available to participants in this trial, can significantly aid burn patients in recovery. One study found that exercise during rehabilitation improved muscle mass, fitness, and overall health. Another study discovered that early initiation of movement, incorporating both aerobic and strength exercises, led to better patient outcomes. Participants in these programs demonstrated significant improvements in hand function and strength. These findings suggest that STAT can enhance recovery and reduce disability following burn injuries. Meanwhile, participants in the standard therapy (ST) group will receive routine burn physical therapy as part of this trial. ^{1 3 6 7 8}

Who Is on the Research Team?

Soman Sen, MD

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with severe burns covering at least 15% of their body, who may need a skin graft. It's not for those with leg amputations, severe heart failure, autoimmune diseases, mobility issues due to neurological conditions, chronic kidney failure requiring dialysis before the injury, or cognitive disorders.

Inclusion Criteria

Survivable burn injury determined by the admitting local burn surgeon on admission

I have burns covering 15% or more of my body, including some third-degree burns.

My burn surgeon says I might need a skin graft.

Exclusion Criteria

You have had autoimmune diseases or connective tissue disorders in the past.

I had a stroke that has left me with difficulty moving.

You have had your leg amputated before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Standard Therapy (ST) or Active Therapy (STAT) after being medically cleared, continuing until discharge from acute care.

Varies until discharge

Daily sessions, 5 days per week

Follow-up

Participants are monitored for long-term outcomes such as return to work, physical activity, and quality of life over a period of 3.5 years.

3.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview

The STAT study compares an activity-based therapy protocol (STAT) against standard therapy (ST) in improving recovery from burn injuries. Participants are randomly assigned to either the STAT group or ST group across seven burn centers.

How Is the Trial Designed?

Group I: Active Therapy (STAT) Experimental Treatment 1 Intervention

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.

Group II: Standard Therapy (ST) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

American Burn Association

Lead Sponsor

Trials

11

Recruited

2,200+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A twelve-week study involving 30 children with lower limb burns showed that combining physical therapy with music therapy significantly improved pain, range of motion, and gait compared to physical therapy alone.

Children receiving the combined treatment (Group A) demonstrated greater improvements in all measured outcomes, indicating that music therapy enhances the effectiveness of rehabilitation for burn injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical therapy rehabilitation program combined with music on children with lower limb burns: A twelve-week randomized controlled study. Eid, MM., Abdelbasset, WK., Abdelaty, FM., et al.[2021]

This systematic review aims to evaluate the effectiveness and safety of therapeutic exercises for burn patients, focusing on both aerobic and strength exercises delivered by various healthcare professionals, which is crucial for improving physical function and quality of life.

The review will include randomized controlled trials of patients with burns of any age and assess the impact of exercise on outcomes like muscle strength and range of movement, with the goal of developing guidelines for effective rehabilitation programs, especially in low-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review protocol on the effectiveness of therapeutic exercises utilised by physiotherapists to improve function in patients with burns. Mudawarima, T., Chiwaridzo, M., Jelsma, J., et al.[2019]

A survey of 103 therapists revealed that while 82% of institutions offer outpatient therapy for burn survivors, 81% reported a lack of hospital-based cardiopulmonary endurance exercise programs, highlighting a gap in rehabilitation services.

The assessment of patients' physical function often relies on subjective measures rather than objective cardiopulmonary parameters, indicating a need for standardized exercise prescriptions and follow-up assessments to enhance the effectiveness of burn rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training after burn injury: a survey of practice. Diego, AM., Serghiou, M., Padmanabha, A., et al.[2021]

A nonsplinting approach to burn rehabilitation has been developed over the past 10 years, focusing on active exercise training and promoting patient independence, which helps reduce reliance on splints.

This program has successfully increased patient compliance with physical therapy by incorporating education for patients and families, along with occasional use of splints to maintain motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nonsplinting approach to the care of the thermally injured patient. Schnebly, WA., Ward, RS., Warden, GD., et al.[2006]

Early physical intervention is crucial for maximizing functional recovery in burn patients, as it helps prevent joint deformities and promotes mobility.

Ongoing evaluation and adjustments to the physical therapy program are necessary due to the frequent changes in a burn patient's condition, allowing therapists to proactively address potential loss of function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors to consider in the rehabilitation aspect of burn care. Giuliani, CA., Perry, GA.[2019]

Rehabilitation for burn injury patients should start immediately upon admission, focusing on restoring strength, coordination, and mobility through baseline assessments and tailored interventions.

In the intermediate and long-term phases, active movement, ambulation, and individualized exercise programs are crucial for preventing muscle and bone atrophy, preserving muscle memory, and achieving lasting rehabilitation success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation in the Acute Versus Outpatient Setting. Hundeshagen, G., Suman, OE., Branski, LK.[2018]

A survey of 159 burn rehabilitation professionals revealed that 97% follow their own treatment plans, indicating a lack of standardized protocols in physical rehabilitation across burn centers.

Common practices among therapists include splinting to prevent contractures and treating complications like exposed tendons, highlighting the need for collaborative studies to evaluate and improve treatment interventions and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Select practices in management and rehabilitation of burns: a survey report. Holavanahalli, RK., Helm, PA., Parry, IS., et al.[2018]

A study of 129 burn patients undergoing inpatient rehabilitation showed significant functional improvements from admission to discharge, indicating the effectiveness of comprehensive rehabilitation in enhancing recovery after burn injuries.

The research found no correlation between the extent of burn injury (total body surface area) and the improvement in functional status, suggesting that all patients, regardless of burn severity, benefit from rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient rehabilitation following burn injury: patient demographics and functional outcomes. Sliwa, JA., Heinemann, A., Semik, P.[2005]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8595583/

Rehabilitative Exercise Training for Burn Injury - PMC

Rehabilitation exercise training (RET) is a proven effective treatment to restore lean body mass, glucose and protein metabolism, cardiorespiratory fitness, ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10560762/

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Following inpatient rehabilitation, survivors with major burns demonstrated a mean improvement of 42% in the dominant hand and 33% in the non-dominant hand in ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1360859225003018

Integrative physiotherapy in burn rehabilitation: Innovations ...

This analysis revealed that early mobilization combined with aerobic and resistance training significantly improved patient outcomes, with Functional ...

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aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04368117?keyword=%22Burn%20Injury%22

STAT: Standard Therapy Plus Active Therapy

This investigation is a multicenter trial involving severely burned patients. The design will be a 1:1 randomized control study comparing the rehabilitation ...

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tandfonline.com

tandfonline.com/doi/full/10.1080/09638288.2024.2327482

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Outcomes included fitness level, hand function, oedema, pain, pruritus, psychological state, quality of life, range of motion, return to work, strength, scar ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3690147/

Exercise Training Following Burn Injury: A Survey of Practice

Physical and occupational therapy, along with nutritional support, aid in the functional recovery of burn survivors. During the past years, progressive ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0305417924000755

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Effect of physical therapy rehabilitation program combined with music on children with lower limb burns: A twelve-week randomized controlled study. Burns, 47 ...

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ameriburn.org

ameriburn.org/wp-content/uploads/2022/02/dod-funding-2021.pdf

Burn Research Studies Funded by DOD

Deliverable: Improved outcomes of burn injured soldiers and civilians in multiple levels of health by establishing a new standard of active physical therapy ...