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Catabolic StateImmobileNCT04467619

Illusory Movements in Patients With Burns

A study testing Functional Proprioceptive Stimulation in people with Catabolic State and Burns, run by Charles University, Czech Republic at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Catabolic State, Burns, Illusions, Kinesthetic
What is being tested?
Functional Proprioceptive Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCzechia
Study dates
26 Jun 2020to 20 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • University Hospital Kralovske Vinohrady

    Prague, 10034

Other trials in Czechia

About this study

Official title: Influence of Illusory Movements on Metabolism in Patients With Large Burns

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.

Read the detailed 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.

  1. 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.

  1. 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.
Being tested
Functional Proprioceptive Stimulation
Keywords
Functional Proprioceptive Stimulation, Illusory Movements, Physiotherapy, Large Burns, The Critically Ill, Catabolism
Medical subject headings
Burns, Illusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Proprioceptive StimulationDevice

    Also called Illusory Movements, Kinesthetic Illusions

    Functional Proprioceptive Stimulations (FPS) are applied on the musculo-tendinous junction. FPS mechanically stimulate the muscle spindles, mimicking the sensory signals - Ia fibers of functional movements. This neurosensory trick activates related sensory-motor areas allowing patients to feel natural movements. Because sensory \& motor systems are interdependent, the central nervous system then reacts by initiating corresponding movements.

Study groups in NCT04467619
Study groupRoleWhat they receive
Early Illusory MovementsActive comparatorPhase 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).
Receives: Device: Functional Proprioceptive Stimulation
Deferred Illusory MovementsActive comparatorPhase 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).
Receives: Device: Functional Proprioceptive Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Energy expenditure

    The use of illusory movements changes energy expenditure in patients with large burns.

    Measured: 2 years

  2. Anticatabolic effect

    The use of illusory movements changes the extent of muscle catabolism in patients with large burns.

    Measured: 2 years

Secondary outcomes (2)
  1. Insulin resistance

    The use of illusory movements changes the extent of insulin resistance in patients with large burns.

    Measured: 2 years

  2. Mitochondrial functions

    The use of illusory movements changes mitochondrial functions of skeletal muscle in patients with large burns.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start26 Jun 2020
  3. Primary completion1 Jun 2024
  4. Study completion20 Sep 2024

Resources

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
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04467619
Sponsor's protocol ID
20200625
Acronym
Immobile
Status last verified
Aug 2023
First submitted
3 Jul 2020
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Roll R, Kavounoudias A, Albert F, Legre R, Gay A, Fabre B, Roll JP. Illusory movements prevent cortical disruption caused by immobilization. Neuroimage. 2012 Aug 1;62(1):510-9. doi: 10.1016/j.neuroimage.2012.05.016. Epub 2012 May 12.

    PubMed 22584228
  • Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.

    PubMed 32054846
  • Waldauf P, Jiroutkova K, Krajcova A, Puthucheary Z, Duska F. Effects of Rehabilitation Interventions on Clinical Outcomes in Critically Ill Patients: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2020 Jul;48(7):1055-1065. doi: 10.1097/CCM.0000000000004382.

    PubMed 32345834

Questions about this trial

What is this clinical trial studying?

A study testing Functional Proprioceptive Stimulation in people with Catabolic State and Burns, run by Charles University, Czech Republic at 1 site in Czechia.

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 5 inclusion and 13 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: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Energy expenditure (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT04467619, which also lists 3 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 7 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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