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.
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;
Show all 13Show fewer
- 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.
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.
- 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.
- 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.
- Conditions
- Catabolic State, Burns, Illusions, Kinesthetic
- 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 group | Role | What they receive |
|---|---|---|
| Early Illusory Movements | Active comparator | 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). Receives: Device: Functional Proprioceptive Stimulation |
| Deferred Illusory Movements | Active comparator | 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). Receives: Device: Functional Proprioceptive Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
The use of illusory movements changes energy expenditure in patients with large burns.
Measured: 2 years
Anticatabolic effect
The use of illusory movements changes the extent of muscle catabolism in patients with large burns.
Measured: 2 years
Secondary outcomes (2)
Insulin resistance
The use of illusory movements changes the extent of insulin resistance in patients with large burns.
Measured: 2 years
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.
- First posted13 Jul 2020
- Study start26 Jun 2020
- Primary completion1 Jun 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catabolic StateStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bohumil Bakalar MD, Charles University, Czech Republic
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 22584228Jeschke 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 32054846Waldauf 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Illusory Movements on Metabolism in Patients With Large Burns
- ClinicalTrials.gov ID
- NCT04467619
- Acronym / sponsor ID
- Immobile / 20200625
- Conditions
- Catabolic State, Burns, Illusions, Kinesthetic
- Keywords
- Functional Proprioceptive Stimulation, Illusory Movements, Physiotherapy, Large Burns, The Critically Ill, Catabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 13 Jul 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.
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.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Illusory Movements | Active comparator | Device: Functional Proprioceptive StimulationPhase 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). |
| Deferred Illusory Movements | Active comparator | Device: Functional Proprioceptive StimulationPhase 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| Functional Proprioceptive StimulationAlso: Illusory Movements, Kinesthetic IllusionsFunctional 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. | Device | Deferred Illusory Movements, Early Illusory Movements |
Primary outcome
Energy expenditure
Time frame: 2 years
The use of illusory movements changes energy expenditure in patients with large burns.
Anticatabolic effect
Time frame: 2 years
The use of illusory movements changes the extent of muscle catabolism in patients with large burns.
2 secondary outcomes
Insulin resistance
Time frame: 2 years
Mitochondrial functions
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 22584228Roll 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.
- Background: PubMed 32054846Jeschke 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.
- Background: PubMed 32345834Waldauf 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.