- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Vivian Essam Sadek Halim, master
- Telefonní číslo: +20 12 82747190
- E-mail: vivianessam123@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
muscle dynamic stiffness
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
lower limb disability
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P.T.REC/012/006564
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