Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Response of Muscle Mechanical Properties to Early Multi-angles Isometric Exercises in Acute Burn Patients (ABP)

16. september 2026 opdateret af: Vivian Essam Sadek Halim, Cairo University

This study will be conducted to investigate the effect of early multi-angle isometric exercise on muscle properties in post-burn patients.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Aktiv 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
muscle dynamic stiffness
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
lower limb disability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

25. marts 2027

Studieafslutning (Anslået)

25. marts 2027

Datoer for studieregistrering

Først indsendt

16. september 2026

Først indsendt, der opfyldte QC-kriterier

16. september 2026

Først opslået (Faktiske)

22. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/006564

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner