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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 14
- 主要终点
- Functional exercise capacity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard Therapy (ST)
Patients randomized to the ST group will receive standard of care, routine burn physical therapy.
干预措施: Physical Therapy (Behavioral)
Active Therapy (STAT)
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.
干预措施: Physical Therapy (Behavioral)
结局指标
主要结局
Functional exercise capacity
时间窗: 3 years
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.
次要结局
- Long-term physical activity- daily distance walked(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-functional task upper extremities(3.5 years)
- Long-term physical activity-gait quality- speed of walking(3.5 years)
- Long-term physical activity-gait quality- cadence of steps(3.5 years)
- Long-term physical activity-gait quality-length of stride when walking(3.5 years)
- Long-term physical activity- calories used(3.5 years)