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Effect of Pressure Biofeedback Training After Ventral Hernioplasty

7. juni 2026 opdateret af: Mai Ayman Abdellatiff, Cairo University

EFFECT OF PRESSURE BIOFEEDBACK ON ABDOMINAL MUSCLES STRENGTH AND QUALITY OF LIFE POST VENTRAL HERNIOPLASTY

The goal of this clinical trial is to evaluate the effect of pressure biofeedback training on abdominal muscle strength and quality of life in adults following ventral hernioplasty. The main questions it aims to answer are:

  • Is there a significant effect of pressure biofeedback training on abdominal muscle strength in patients following ventral hernioplasty?
  • Is there a significant effect of pressure biofeedback training on quality of life in patients following ventral hernioplasty?

Researchers will compare the effect of adding pressure biofeedback training to a conventional physical therapy program versus a conventional physical therapy program alone to determine whether pressure biofeedback training provides additional benefits in improving abdominal muscle strength and quality of life following ventral hernioplasty.

Participants in the study group will receive pressure biofeedback training in addition to the conventional physical therapy program, while participants in the control group will receive the conventional physical therapy program only.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Egypten
      • Giza, Egypten
        • Faculty of Physical Therapy Cairo University

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

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Both males and females
  • Their ages ranged 35 to 50
  • Their BMI ranged from 18.5 to 27
  • All patients were suffering from muscles weakness post-ventral hernioplasty
  • All patients began the treatment program 8 weeks post-ventral hernioplasty
  • All patients received the same postoperative physical therapy program
  • Informed consent was obtained from every patient enrolled in the trial.

Exclusion Criteria:

  • Pregnancy
  • Postpartum less than 6 months.
  • Peritonitis
  • Bruising or swelling of the abdominal wall.
  • Infection
  • Musculoskeletal impairments that may hinder the treatment process.
  • Orthopedic impairment that may hinder the treatment process.
  • Lumbar surgery in the past year.
  • Spinal stenosis.
  • Neurological disease.
  • Trauma to the lumbar spine.
  • Nerve root entrapment.
  • Cancer.
  • Pre-existing impairment of cardiac function.
  • Bone metastasis.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: kontrolgruppe
Andet: conventional physical therapy program
A conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device.
Eksperimentel: studiegruppe
Andet: pressure biofeedback training
participants in study group will receive 30 mins and 3 sessions per week for 8 weeks
Andet: conventional physical therapy program
A conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
abdominal muscle strength
Tidsramme: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
  • Abdominal muscle strength assessment was performed using a pressure biofeedback unit (PBU) to evaluate the activation of the transversus abdominis (TrA) muscle.
  • Participants were positioned in a prone lying position on a firm surface, with their arms relaxed by their sides.
  • The PBU was placed under the abdomen such that the navel is centered on the device, and the distal edge is aligned with the right and left anterior superior iliac spines.
  • The cuff was inflated to 70 mmHg and allowed to stabilize. Normal breathing fluctuations (approximately ±2 mmHg) will be noted, after which participants will be instructed to perform the abdominal draw-in maneuver.
  • A pressure reduction of 6-10 mmHg is expected.
  • A reduction in pressure held for a minimum of 10 seconds is considered a successful activation of the TrA.
  • The procedure was repeated three times, and the average reduction of the three readings was used for analysis; higher scores indicate better abdominal muscle strength.
Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
Health-Related Quality of Life
Tidsramme: Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.
The Arabic version of the 12-Item Short Form Health Survey (SF-12) was used to assess health-related quality of life (HRQoL) before and after the intervention. The SF-12 consists of 12 items covering eight health domains: General Health, Physical Functioning, Role Physical, Bodily Pain, Mental Health, Social Functioning, Role Emotional, and Vitality. Responses were scored using the standard SF-12 scoring algorithm, which applies specific weights to each item according to its contribution to physical and mental health. Weighted scores were combined to generate the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12). Both scores are standardized on a 0-100 scale, with higher scores indicating better HRQoL. Changes in pre- and post-intervention scores were used to evaluate the intervention effect.
Measurements were taken at the baseline (pre-treatment), after 8 weeks (post-treatment), and after 14 weeks as a follow-up.

Samarbejdspartnere og efterforskere

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

Sponsor

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)

6. oktober 2025

Primær færdiggørelse (Faktiske)

30. april 2026

Studieafslutning (Faktiske)

30. april 2026

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • P.T.REC/012/006111

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Reparation af ventral brok

Kliniske forsøg med pressure biofeedback training

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