Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

15 mars 2022 uppdaterad av: 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 .

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

• 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.

Studietyp

Interventionell

Inskrivning (Förväntat)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

25 år till 40 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Övrig: 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)
Övrig: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Walaa Abd Elaziem Abd Elaziz

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 april 2021

Primärt slutförande (Förväntat)

15 maj 2022

Avslutad studie (Förväntat)

30 maj 2022

Studieregistreringsdatum

Först inskickad

27 april 2021

Först inskickad som uppfyllde QC-kriterierna

30 april 2021

Första postat (Faktisk)

3 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 mars 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P.T.REC/012/002906

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera