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Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury

15. marts 2022 opdateret af: Walaa Abd Elaziem Abd Elaziz
The aim of this study is to examine whether Pulsed Electromagnetic Field therapy combined with strengthening exercises will have a positive effect on quadriceps muscle strength in lower limb burn .

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

• Subjects: Sixty patients with lower limb burn, subdivided into two groups each one has 30 patients.

  • Group (A) = Pulsed Electromagnetic Field therapy and quadriceps strengthening exercises group.

  • Group (B) = quadriceps strengthening exercises group. • Equipment and tools:

    1. Measurements tools:

      Isokinetic dynamometer : to measure the quadriceps muscle peak torque before the treatment and after 8 weeks of treatment for both groups.

    2. Therapeutic tools:

Pulsed Electromagnetic Field therapy device and free weights for strengthening of quadriceps muscle.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Egypten
    • Giza
      • Dokki, Giza, Egypten, 12613
        • Rekruttering
        • Cairo University
        • Kontakt:

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

25 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • - Patients are males.
  • Their age will range from (25-40) years.
  • Patients will suffer from second-degree burn ( Partial thickness of thermal injury).
  • Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
  • They will be selected from Outpatient Clinic of Faculty of Physical Therapy and Burn Unit at Om El-Obour Hospital.
  • Patients will begin the training program after complete wound healing.
  • All patients will receive traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living.
  • Patients will be given their informed consent.

Exclusion Criteria:

  • - Patients who participate in any rehabilitation program to improve muscle strength prior to the study.
  • Musculoskeletal disorders that will impair performance during training and tests.
  • Equilibrium disorders.
  • Uncontrolled cardiovascular or pulmonary diseases .
  • Neurological and renal disorders.
  • metabolic or vascular disease with a neurological component such as diabetes,
  • Malignant conditions.
  • Psychiatric illness, severe behavior or cognitive disorders.
  • Subjects with burn to the posterior thigh with knee flexion contracture, which affected the function of the quadriceps muscle.
  • Lower limb lymphedema or lipoedema.
  • Athletic subjects.
  • Subjects with morbid obesity.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
- This group will be composed of 30 patients with lower limb burn of second-degree. Subjects will receive pulsed magnetic field over thigh areas for 24 sessions over a period of 8 weeks (3sessions/week) with receiving strengthening exercises for quadriceps muscle and traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living.
Enhed: pulsed electromagnetic field device
the pulsed electromagnetic field device treatment parameters will be set as 15 Hz frequency, 20 gauss amplitude, and 20 minutes as total treatment duration.
Andet: Free weights for Strengthening Exercise

• Parameters of the exercise program: Intensity : The weight or load the patients lifted is set at 50-60% of their individual 1RM , 3 sets of 10 repetitions during the first week. During the second week, the lifting load is increased to 70-75% (3 sets of 10 repetitions) of their individual 1RM and continued for weeks 2-6. After this, training intensity is increased to 80-85% of the 1 RM and implemented from weeks 7-8.

Frequency: 3 sessions per week for 8 weeks. Number of repetitions: 3 sets,10 repetitions in each set. Total treatment duration: 8 weeks
Aktiv komparator: control group
Subjects will receive strengthening exercises for quadriceps muscle and traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living for 24 sessions over a period of 8 weeks (3sessions/week)
Andet: Free weights for Strengthening Exercise

• Parameters of the exercise program: Intensity : The weight or load the patients lifted is set at 50-60% of their individual 1RM , 3 sets of 10 repetitions during the first week. During the second week, the lifting load is increased to 70-75% (3 sets of 10 repetitions) of their individual 1RM and continued for weeks 2-6. After this, training intensity is increased to 80-85% of the 1 RM and implemented from weeks 7-8.

Frequency: 3 sessions per week for 8 weeks. Number of repetitions: 3 sets,10 repetitions in each set. Total treatment duration: 8 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
Tidsramme: 8 weeks
  • Patients will warm up for 5 min on a cycle ergometer then quadriceps, hamstrings and calf muscles will be stretched 3 times with a 30 seconds stretch and a 30 seconds rest.
  • Patients will be positioned in an isokinetic dynamometer. The measurements are carried out with the backrest reclined 5° from vertical and knees flexed 90 degrees and straps fixing the trunk, waist and distal thigh. The rotation axis of the dynamometer is aligned with the axis of the knee joint at the level of the lateral epicondyle of the femur while it is attached to the distal part of the leg about 5cm above the medial malleolus and isokinetic test is performed at angular velocity of 150 degree per second.
  • For familiarization, Patients will perform a series of three submaximal contractions. After warming up, subjects are requested to perform ten maximal voluntary contractions consecutively without rest in between.
  • There will be three minutes of resting before repeating the test
8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Walaa Abd Elaziem Abd Elaziz

Efterforskere

  • Ledende efterforsker: Walaa A Elaziz, master, lecturer assistant at faculty of physical therapy, Cairo University

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 (Faktiske)

25. april 2021

Primær færdiggørelse (Forventet)

15. maj 2022

Studieafslutning (Forventet)

30. maj 2022

Datoer for studieregistrering

Først indsendt

27. april 2021

Først indsendt, der opfyldte QC-kriterier

30. april 2021

Først opslået (Faktiske)

3. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P.T.REC/012/002906

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Kliniske forsøg med Burn i underekstremiteten

Kliniske forsøg med pulsed electromagnetic field device

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