Illusory Movements in Patients With Burns

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    20
  • sponsor
    Charles University, Czech Republic
Updated on 24 January 2021
Investigator
Bohumil Bakalar, MD
Primary Contact
University Hospital Kralovske Vinohrady (1.2 mi away) Contact
insulin

Summary

Background. Large burns are the cause of extensive skeletal muscle devastation. The possibilities of rehabilitation of such patients are very limited, which contributes to the risk of metabolic failure and long-term musculoskeletal disorders. Illusory movements are a relatively new method of physiotherapy, which through functional proprioceptive stimulation enables the integration and networking of muscle units and has a neurotrophic effect on the cerebral cortex. In our pilot study, we demonstrated that illusory movements significantly increased basal energy expenditure in extensively burned patients in a catabolic state and with healing impairment in the later stage of burn disease. However, the metabolic effects of illusory movements have not yet been studied.

Tested hypotheses. 1. The use of illusory movements is suitable for the rehabilitation of patients with burns on 20% or more of the total body surface area (TBSA) in the early phase of the burn disease. 2. The use of illusory movements in these patients attenuates the extent of muscle catabolism.

Method. Pragmatic crossover study. Twenty patients with burns on 20% or more of the body surface area will be divided into two groups. They will be rehabilitated early or delayed by illusory movements for 14 days. Among other things, the following metabolic parameters will be monitored: nitrogen balance, basal and resting energy expenditure (BMR, REE), insulin resistance (IR), myokinins levels, muscle mitochondrial function and their morphology, and ultrasound cross-sectional diameter of the rectus femoris muscle. The control group will consist of ten healthy volunteers, in whom resting energy expenditure before and after using illusory movements exercise will be measured.

Description

The goal of this project is to find out whether illusory movements are suitable for patients in the early phase of burn disease, and how they influence patients' metabolism.

We are going to test these hypotheses:

  • The use of illusory movements is suitable for patients with burns of 20 % TBSA and more in the early acute phase of the burn disease.
  • The use of illusory movements reduces the extent of muscle catabolism in patients with large burns.

Way of solution This is a pragmatic cross-over study in patients with burns of 20 % TBSA or more in the early acute phase of the burn disease, who are expected to be hospitalized for 35 days or more. Patients meeting the inclusion criteria will be divided into two groups, A (n = 10) and B (n = 10). Group C will consist of healthy volunteers (n = 10).

The study will start after patient's basic cardiopulmonary stabilization, which usually corresponds to days 3-5 after the injury.

Group A: Early illusory movements Phase 1: A patient enrolled in group A will have standard rehabilitation according to the instructions of the attending surgeon and performed by an independent physiotherapist from the start of the study (Day 1), and also FPS performed by a study nurse will take place for 30 minutes twice a day, 2 hours or more after the end of standard rehabilitation, for 14 days (Day 15).

Phase 2: From Day 16 onwards, the patient will undergo standard rehabilitation only according to the instructions of the attending surgeon and performed by an independent physiotherapist for 14 days (Day 30).

Group B: Deferred illusory movements Phase 1: A patient enrolled in group B will have standard rehabilitation according to the instructions of the attending surgeon and performed by an independent physiotherapist, from the start of the study (Day 1) for 14 days (Day 15).

Phase 2: Then, from Day 16 onwards, in addition to standard physiotherapy, FPS performed by a study nurse will take place for 30 minutes twice a day, 2 hours or more after the end of standard rehabilitation, for 14 days (Day 30).

Group C: Illusory movements in healthy individuals This group will consist of 10 healthy volunteers in whom REE will be measured before and after 30 minutes of FPS.

c) Medical, social and economic rationale of this study Large burns are often the cause of neuromyopathy and disability of the injured [30]. Hypercatabolism and enormous muscle loss increase the morbidity and mortality of patients, prolong treatment and greatly increase the overall cost of medical care [31]. Early rehabilitation using illusory movements could reduce the extent of muscle devastation in otherwise immobile patients and improve the effect of standard rehabilitation by maintaining functional brain maps. This should lead to an earlier return of the injured to their normal activities a improve quality of life.

In addition, if the positive effects of illusory movements are proved, there are many critically ill patients outside the burns who could benefit from this form of physiotherapy.

d) Methodology Nutrition support will be provided in accordance with European Society of Parenteral and Enteral Nutrition recommendations.

During the study, the following parameters will be measured, and the following examinations will be performed in addition to standard biochemical, haematological and imaging examinations of Group A and B:

Daily
  • Nitrogen balance;
  • Resting Energy Expenditure using indirect calorimetry;

On Days 1, 15 and 30:

  • Patient weight;
  • APACHE II score;
  • Muscle biopsy (from m. vastus lateralis);
  • BMR;
  • Glucose disposal using a hyperinsulinaemic euglycaemic clamp;
  • Degree of insulin resistance according to Homeostasis Model Assessment;
  • Muscle mitochondrial respiratory capacity and coupling with the Oxygraph-2K;
  • Mitochondrial mass determination and dynamics in myocytes with MitoTracker ;
  • Plasmatic levels of myokinins ;
  • Ultrasound measurement of the rectus femoris diameter measured by an independent sonographer.

Details
Condition Trauma, Illusion, Burns, Burns and Burn Infections, Wounds, Catabolic State, burn injuries
Treatment Functional Proprioceptive Stimulation
Clinical Study IdentifierNCT04467619
SponsorCharles University, Czech Republic
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 and older
Consent to be included in the study
Burns II. - III. grade on 20 % TBSA and more
Admission within 72 hours of the accident
Expected hospital stay of 35 days or more

Exclusion Criteria

Age <18 years
Refusal of the study in any point
Unlikely patient survival (Revised Baux Index> 120)
Known primary neuromuscular diseases or spinal cord lesions
Limb amputation before or during the study
Bed rest before admission
Pregnancy
External fixator or surface metal implant on the limbs
Known malignancy or history of malignancy treatment in the last 5 years
History of HIV or AIDS
Concomitant treatment with systemic corticosteroids
Pacemaker, implanted defibrillator, or another bio-electronic device
Patient in prison
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note