Burn InjurySTATNCT04368117
STAT: Standard Therapy Plus Active Therapy
A study testing Physical Therapy in people with Burn Injury and Physical Injury, run by American Burn Association at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Injury, Physical Injury, Thermal Burn
- What is being tested?
- Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Oct 2020to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
Health and Hospital Corporation dba Eskenazi Health
Indianapolis, Indiana, 46202
Loyola University Medical Center
Maywood, Illinois, 60153
ValleyWise Health
Phoenix, Arizona, 85008
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, 95817
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the detailed 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.
- Conditions
- Burn Injury, Physical Injury, Thermal Burn
- Being tested
- Physical Therapy
- Keywords
- Physical impairment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyBehavioural
Directed and prescribe physical therapy program for severely burned patients
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy (ST) | Active comparator | Patients randomized to the ST group will receive standard of care, routine burn physical therapy. Receives: 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. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (8)
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.
Measured: 3.5 years
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.
Measured: 3.5 years
Long-term physical activity- daily steps
Total daily steps taken will be measured using a wearable monitor in both STAT and ST
Measured: 3.5 years
Long-term physical activity- daily distance walked
Daily distance walked will be measured using a wearable monitor in both STAT and ST
Measured: 3.5 years
Long-term physical activity- calories used
Daily calories used will be measured using a wearable monitor in both STAT and ST
Measured: 3.5 years
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
Measured: 3.5 years
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
Measured: 3.5 years
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
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start26 Oct 2020
- Primary completion29 Sep 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Severely burn injured with a 15% TBSA of burn injury or larger who require a skin graft surgery
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Soman Sen, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368117
- Sponsor's protocol ID
- 1552346
- Other IDs
- W81XWH-19-2-0043
- Acronym
- STAT
- Status last verified
- May 2026
- First submitted
- 8 Apr 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available to researchers through the Burn Science Advisory Panel of the American Burn Association
Publications
Bloomfield SA. Changes in musculoskeletal structure and function with prolonged bed rest. Med Sci Sports Exerc. 1997 Feb;29(2):197-206. doi: 10.1097/00005768-199702000-00006.
PubMed 9044223Kortebein P, Ferrando A, Lombeida J, Wolfe R, Evans WJ. Effect of 10 days of bed rest on skeletal muscle in healthy older adults. JAMA. 2007 Apr 25;297(16):1772-4. doi: 10.1001/jama.297.16.1772-b. No abstract available.
PubMed 17456818Suesada MM, Martins MA, Carvalho CR. Effect of short-term hospitalization on functional capacity in patients not restricted to bed. Am J Phys Med Rehabil. 2007 Jun;86(6):455-62. doi: 10.1097/PHM.0b013e31805b7566.
PubMed 17515684Convertino V, Hung J, Goldwater D, DeBusk RF. Cardiovascular responses to exercise in middle-aged men after 10 days of bedrest. Circulation. 1982 Jan;65(1):134-40. doi: 10.1161/01.cir.65.1.134.
PubMed 6796287De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
PubMed 12472328Convertino VA; New Collective Author. Cardiovascular consequences of bed rest: effect on maximal oxygen uptake. Med Sci Sports Exerc. 1997 Feb;29(2):191-6. doi: 10.1097/00005768-199702000-00005.
PubMed 9044222Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR; New Collective Author. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. doi: 10.1152/ajpendo.1996.270.4.E627.
PubMed 8928769Powers SK, Wiggs MP, Duarte JA, Zergeroglu AM, Demirel HA. Mitochondrial signaling contributes to disuse muscle atrophy. Am J Physiol Endocrinol Metab. 2012 Jul 1;303(1):E31-9. doi: 10.1152/ajpendo.00609.2011. Epub 2012 Mar 6.
PubMed 22395111Hart DW, Wolf SE, Mlcak R, Chinkes DL, Ramzy PI, Obeng MK, Ferrando AA, Wolfe RR, Herndon DN. Persistence of muscle catabolism after severe burn. Surgery. 2000 Aug;128(2):312-9. doi: 10.1067/msy.2000.108059.
PubMed 10923010Klein GL, Herndon DN, Goodman WG, Langman CB, Phillips WA, Dickson IR, Eastell R, Naylor KE, Maloney NA, Desai M, et al. Histomorphometric and biochemical characterization of bone following acute severe burns in children. Bone. 1995 Nov;17(5):455-60. doi: 10.1016/8756-3282(95)00279-1.
PubMed 8579956Klein GL, Herndon DN, Rutan TC, Sherrard DJ, Coburn JW, Langman CB, Thomas ML, Haddad JG Jr, Cooper CW, Miller NL, et al. Bone disease in burn patients. J Bone Miner Res. 1993 Mar;8(3):337-45. doi: 10.1002/jbmr.5650080311.
PubMed 8456588Kress JP. Clinical trials of early mobilization of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S442-7. doi: 10.1097/CCM.0b013e3181b6f9c0.
PubMed 20046133Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
PubMed 19623052Kayambu G, Boots R, Paratz J. Early physical rehabilitation in intensive care patients with sepsis syndromes: a pilot randomised controlled trial. Intensive Care Med. 2015 May;41(5):865-74. doi: 10.1007/s00134-015-3763-8. Epub 2015 Apr 8.
PubMed 25851383Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
PubMed 18596631
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04368117
- Acronym / sponsor ID
- STAT / 1552346
- Conditions
- Burn Injury, Physical Injury, Thermal Burn
- Keywords
- Physical impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Severely burn injured with a 15% TBSA of burn injury or larger who require a skin graft surgery
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy (ST) | Active comparator | Behavioral: Physical TherapyPatients randomized to the ST group will receive standard of care, routine burn physical therapy. |
| Active Therapy (STAT) | Experimental | Behavioral: Physical TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyDirected and prescribe physical therapy program for severely burned patients | Behavioural | Active Therapy (STAT), Standard Therapy (ST) |
Primary outcome
Functional exercise capacity
Time frame: 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.
8 secondary outcomes
Long-term physical activity-functional task upper extremities
Time frame: 3.5 years
Long-term physical activity- functional task lower extremities
Time frame: 3.5 years
Long-term physical activity- daily steps
Time frame: 3.5 years
Long-term physical activity- daily distance walked
Time frame: 3.5 years
Long-term physical activity- calories used
Time frame: 3.5 years
Long-term physical activity-gait quality- speed of walking
Time frame: 3.5 years
Long-term physical activity-gait quality- cadence of steps
Time frame: 3.5 years
Long-term physical activity-gait quality-length of stride when walking
Time frame: 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 9044223Bloomfield SA. Changes in musculoskeletal structure and function with prolonged bed rest. Med Sci Sports Exerc. 1997 Feb;29(2):197-206. doi: 10.1097/00005768-199702000-00006.
- Background: PubMed 17456818Kortebein P, Ferrando A, Lombeida J, Wolfe R, Evans WJ. Effect of 10 days of bed rest on skeletal muscle in healthy older adults. JAMA. 2007 Apr 25;297(16):1772-4. doi: 10.1001/jama.297.16.1772-b. No abstract available.
- Background: PubMed 17515684Suesada MM, Martins MA, Carvalho CR. Effect of short-term hospitalization on functional capacity in patients not restricted to bed. Am J Phys Med Rehabil. 2007 Jun;86(6):455-62. doi: 10.1097/PHM.0b013e31805b7566.
- Background: PubMed 6796287Convertino V, Hung J, Goldwater D, DeBusk RF. Cardiovascular responses to exercise in middle-aged men after 10 days of bedrest. Circulation. 1982 Jan;65(1):134-40. doi: 10.1161/01.cir.65.1.134.
- Background: PubMed 12472328De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
- Background: PubMed 9044222Convertino VA; New Collective Author. Cardiovascular consequences of bed rest: effect on maximal oxygen uptake. Med Sci Sports Exerc. 1997 Feb;29(2):191-6. doi: 10.1097/00005768-199702000-00005.
- Background: PubMed 8928769Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR; New Collective Author. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. doi: 10.1152/ajpendo.1996.270.4.E627.
- Background: PubMed 22395111Powers SK, Wiggs MP, Duarte JA, Zergeroglu AM, Demirel HA. Mitochondrial signaling contributes to disuse muscle atrophy. Am J Physiol Endocrinol Metab. 2012 Jul 1;303(1):E31-9. doi: 10.1152/ajpendo.00609.2011. Epub 2012 Mar 6.
- Background: PubMed 10923010Hart DW, Wolf SE, Mlcak R, Chinkes DL, Ramzy PI, Obeng MK, Ferrando AA, Wolfe RR, Herndon DN. Persistence of muscle catabolism after severe burn. Surgery. 2000 Aug;128(2):312-9. doi: 10.1067/msy.2000.108059.
- Background: PubMed 8579956Klein GL, Herndon DN, Goodman WG, Langman CB, Phillips WA, Dickson IR, Eastell R, Naylor KE, Maloney NA, Desai M, et al. Histomorphometric and biochemical characterization of bone following acute severe burns in children. Bone. 1995 Nov;17(5):455-60. doi: 10.1016/8756-3282(95)00279-1.
- Background: PubMed 8456588Klein GL, Herndon DN, Rutan TC, Sherrard DJ, Coburn JW, Langman CB, Thomas ML, Haddad JG Jr, Cooper CW, Miller NL, et al. Bone disease in burn patients. J Bone Miner Res. 1993 Mar;8(3):337-45. doi: 10.1002/jbmr.5650080311.
- Background: PubMed 20046133Kress JP. Clinical trials of early mobilization of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S442-7. doi: 10.1097/CCM.0b013e3181b6f9c0.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available to researchers through the Burn Science Advisory Panel of the American Burn Association
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soman Sen, MD principal investigator
UC Davis
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Burn Injury and Physical Injury, run by American Burn Association at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04368117, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.