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Physical Therapy for Burns (STAT Trial)

N/A

Recruiting

Led By Soman Sen, MD

Research Sponsored by American Burn Association

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 65 years old

Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

STAT Trial Summary

This trial will compare the efficacy of two different therapy protocols to improve functional outcome and reduce disability in patients recovering from burn injury.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves physical therapy interventions rather than drug treatments, side effects might include muscle soreness, fatigue during recovery sessions and potential strain on burn wounds during activities.

STAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

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

STAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional exercise capacity

Secondary outcome measures

Long-term physical activity- calories used

Long-term physical activity- daily distance walked

Long-term physical activity- daily steps

+5 more

Other outcome measures

Hospital length of stay

Incidence of cardiovascular complications

Incidence of post surgical complications

+8 more

STAT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active Therapy (STAT)Experimental Treatment1 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 Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Therapy

2020

Completed Phase 4

~1460

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Burn AssociationLead Sponsor

10 Previous Clinical Trials

1,988 Total Patients Enrolled

8 Trials studying Burns

1,880 Patients Enrolled for Burns

United States Department of DefenseFED

865 Previous Clinical Trials

327,533 Total Patients Enrolled

17 Trials studying Burns

1,357 Patients Enrolled for Burns

Soman Sen, MDPrincipal InvestigatorUC Davis

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04368117 — N/A

Burns Research Study Groups: Active Therapy (STAT), Standard Therapy (ST)

Burns Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT04368117 — N/A

Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04368117 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol accept individuals aged 30 years and older?

"This study is seeking participants that are of legal age (18+) and below the pensionable age (65-)."

Answered by AI

Are any additional places available to join this experimental protocol?

"Confirmed, the information hosted on clinicaltrials.gov attests to this trial's active recruitment phase; it was originally posted on October 26th 2020 and last modified on August 7th 2022."

Answered by AI

In what geographic locations can this research be accessed?

"Currently, 7 medical facilities are recruiting patients for this trial. These include Sacramento, Maywood and Fort Sam Houston as well as 4 additional sites. It would be advantageous to select the closest clinic in order to mitigate any travel burdens if you decide to participate."

Answered by AI

How many subjects are engaged in this medical experiment?

"To begin this trial, 166 participants who satisfy the criteria must be recruited. The two designated sites for these enrollees are University of California Davis Medical Center-Regional Burn Center in Sacramento, CA and Loyola University Medical Center in Maywood, IL."

Answered by AI

Who may submit an application for consideration in this clinical trial?

"This trial is seeking 166 subjects aged 18 to 65 who have experienced burn injuries. Strict inclusion criteria necessitates that the attending surgeon deem a patient eligible for skin grafting, and assesses the injury as survivable upon admission. Additionally, a total TBSA (total body surface area) of 15% or more needs to be present with 10% being third-degree burns."

Answered by AI

Recent research and studies

Medicine &amp Science in Sports &amp ExerciseJournal

Changes in Musculoskeletal Structure and Function with Prolonged Bed Rest

BLOOMFIELD, SUSAN A.. 1997. “Changes in Musculoskeletal Structure and Function with Prolonged Bed Rest”. Medicine &amp Science in Sports &amp Exercise. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005768-199702000-00006.

Critical Care MedicineJournal

Early Exercise in Critically Ill Patients Enhances Short-term Functional Recovery*

Burtin, Chris, Beatrix Clerckx, Christophe Robbeets, Patrick Ferdinande, Daniel Langer, Thierry Troosters, Greet Hermans, Marc Decramer, and Rik Gosselink. 2009. “Early Exercise in Critically Ill Patients Enhances Short-term Functional Recovery*”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ccm.0b013e3181a38937.

American Journal of Physical Medicine & RehabilitationJournal

Effect of Short-term Hospitalization on Functional Capacity in Patients Not Restricted to Bed

Suesada, Milena M., Milton A. Martins, and Celso R. F. Carvalho. 2007. “Effect of Short-term Hospitalization on Functional Capacity in Patients Not Restricted to Bed”. American Journal of Physical Medicine & Rehabilitation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/phm.0b013e31805b7566.

The LancetJournal