- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04870528
Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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:
Measurements tools:
Isokinetic dynamometer : to measure the quadriceps muscle peak torque before the treatment and after 8 weeks of treatment for both groups.
- Therapeutic tools:
Pulsed Electromagnetic Field therapy device and free weights for strengthening of quadriceps muscle.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Walaa A Abd Elaziz, master
- Telefonnummer: 020 01099386825
- E-post: walaaamr106@gmail.com
Studiesteder
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-
Giza
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Dokki, Giza, Egypt, 12613
- Rekruttering
- Cairo University
-
Ta kontakt med:
- Walaa A Abd Elaziz, master
- Telefonnummer: 020 01099386825
- E-post: walaaamr106@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
the pulsed electromagnetic field device treatment parameters will be set as 15 Hz frequency, 20 gauss amplitude, and 20 minutes as total treatment duration.
• 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)
|
• 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Isokinetic dynamometer for measuring The peak torque of the quadriceps muscle
Tidsramme: 8 weeks
|
|
8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Walaa A Elaziz, master, lecturer assistant at faculty of physical therapy, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P.T.REC/012/002906
Plan for individuelle deltakerdata (IPD)
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