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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Physical Therapy for Burns?

Research shows that starting rehabilitation early after a burn injury helps restore strength, coordination, and mobility. Therapeutic exercises, including aerobic and strength exercises, are crucial in improving function and quality of life for burn patients. ^{1 2 3 4 5}

Is physical therapy safe for burn patients?

Physical therapy, including exercises and rehabilitation programs, is generally considered safe for burn patients. Studies show that it helps improve strength, coordination, and mobility, and is a common practice in burn rehabilitation without significant safety concerns reported. ^{1 2 3 6 7}

How is physical therapy for burns different from other treatments?

Physical therapy for burns is unique because it focuses on early intervention to prevent joint deformity and emphasizes active exercises and patient independence rather than relying on splints. This approach includes personalized exercise programs and education for both patients and families to promote long-term functional recovery. ^{1 2 3 4 8}

Research Team

Soman Sen, MD

Principal Investigator

UC Davis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Select practices in management and rehabilitation of burns: a survey report. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation in the Acute Versus Outpatient Setting. [2018]

3. England 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Factors to consider in the rehabilitation aspect of burn care. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Inpatient rehabilitation following burn injury: patient demographics and functional outcomes. [2005]

6. Netherlands 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Exercise training after burn injury: a survey of practice. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A nonsplinting approach to the care of the thermally injured patient. [2006]