Illusory Movements in Patients With Burns

NCT04467619 | Completed

• 1 other identifier: 20200625
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catabolic State; Burns; Illusions, Kinesthetic

Keywords

Functional Proprioceptive Stimulation; Illusory Movements; Physiotherapy; Large Burns; The Critically Ill; Catabolism

Outcome Measures

Primary Outcomes (2)

• Energy expenditure

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

  2 years

• Anticatabolic effect

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

  2 years

Secondary Outcomes (2)

• Insulin resistance

  2 years

• Mitochondrial functions

  2 years

Study Arms (2)

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).

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).

Device: Functional Proprioceptive Stimulation

Interventions

Functional Proprioceptive Stimulation DEVICE

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.

Also known as: Illusory Movements, Kinesthetic Illusions

Deferred Illusory Movements; Early Illusory Movements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 10034, Czechia

Location

Related Publications (3)

• 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.

  PMID: 22584228 BACKGROUND

• 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.

  PMID: 32054846 BACKGROUND

• 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.

  PMID: 32345834 BACKGROUND

MeSH Terms

Conditions

Burns; Illusions

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Head of ITU, Prague Burn Center, 3rd Medical School, Prague

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 13, 2020
• Study Start: June 26, 2020
• Primary Completion: June 1, 2024
• Study Completion: September 20, 2024
• Last Updated: January 7, 2026

Record last verified: 2023-08

Locations

CZ (1)