- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07832955
Response of Muscle Mechanical Properties to Early Multi-angles Isometric Exercises in Acute Burn Patients (ABP)
This study will be conducted to investigate the effect of early multi-angle isometric exercise on muscle properties in post-burn patients.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
A burn injury represents the fourth most common type of trauma globally, though it is associated with the most devastating consequences Severe burn injuries, encompassing ≥20% of the total body surface area (TBSA) in adults, present a unique challenge compared with other forms of trauma given the magnitude and persistence of systemic dysregulation.Burns can occur when the skin is exposed to heat sources, such as flames, flash burns, hot objects, grease, scald, chemicals, and electricity Burn injuries are highly variable, as is their severity. The patient's comorbidities can influence the burn's clinical outcome. Additionally, morbidity and mortality tend to increase as the surface area of the burn increases .Isometric exercise is a static form of exercise in which a muscle contracts and produces force without an appreciable change in the length of the muscle and without visible joint motion. Although there is no mechanical work done (force × distance), a measurable amount of tension and force output are produced by the muscle. Sources of resistance for isometric exercise include holding against a force applied manually, holding a weight in a particular position, maintaining a position against the resistance of body weight, or pushing or pulling an immovable object.Although post-burn muscle wasting is widely recognized, it is not consistently targeted as a primary rehabilitation outcome during the acute phase of care. Furthermore, there is a lack of randomized controlled trials examining the effects of early Multi- angle isometric exercise on objective measures of muscle mechanical properties in acute burn patients using sensitive technology like the MyotonPRO.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Vivian Essam Sadek Halim, master
- Numer telefonu: +20 12 82747190
- E-mail: vivianessam123@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Male and female patients aged 20 to 40 years
- Patients diagnosed with acute burns.
- Total Body Surface Area (TBSA) ranging from 15% to 30%, 2nd degree burn patients.
- Medically stable patients.
- Patients within the first 4 weeks post-burn (acute stage).
- Burns affecting lower limb muscles (Quadriceps, Hamstring , and calf muscles ) .
Exclusion Criteria:
- Patients with third-degree burns requiring immediate surgical grafting at the assessment site.
- Patients with associated fractures or neurological disorders.
- Patients with severe cardiopulmonary instability.
- Patients under mechanical ventilation.
- Patients with systemic diseases affecting muscle properties (e.g., neuromuscular disorders).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: isometric exercise program
20 patients will receive early Multi-angle isometric exercise program in addition to conventional physical therapy 3 times per week for 3 weeks. |
isometric exercises targeting the affected muscle groups Lower limb muscles. Exercises will begin within the first week post-burn after medical stabilization, Isometric contractions will be performed at submaximal intensity (approximately 50-60% of maximum voluntary contraction).Each contraction will be held for 5-10 seconds followed by 10 seconds of relaxation. Each muscle group will perform 10 repetitions per set in addition to conventional physical therapy Conventional physical therapy programs include positioning, mobilization, range of motion exercises, stretching and splinting |
|
Aktywny komparator: conventional physical therapy
20 patients will receive conventional physical therapy 3 times per week for 3 weeks. |
Conventional physical therapy programs include positioning, mobilization, range of motion exercises, stretching and splinting |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
muscle dynamic stiffness
Ramy czasowe: up to 3 weeks
|
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle dynamic stiffness. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher dynamic stiffness indicates greater resistance to force application. |
up to 3 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
lower limb disability
Ramy czasowe: up to 3 weeks
|
The Lower Extremity Functional Scale (LEFS) is a patient-reported outcome measure which assesses the functional status of patients who have lower extremity conditions of musculoskeletal origin. The 20-item questionnaire inquires as to the degree of difficulty of performance of each of these activities on a 5-point Likert scale and a score of 80 represents an individula with normal functions |
up to 3 weeks
|
|
oscillatory frequency
Ramy czasowe: up to 3 weeks
|
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess oscillation frequency. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher oscillation frequency indicates higher muscle tone, while increased stiffness reflects greater resistance to force application. |
up to 3 weeks
|
|
muscle elasticity
Ramy czasowe: up to 3 weeks
|
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle elasticity. it quantifies the dissipation of mechanical energy (damping) during natural oscillations of a muscle. lower values signify higher elasticity (i.e., better ability to recover from deformation), while higher values suggest lower elasticity. |
up to 3 weeks
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/006564
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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