Effect of Pressure Biofeedback Training After Ventral Hernioplasty

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia Repair
• Intervention / Treatment: Other: pressure biofeedback training; Other: conventional physical therapy program

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Other: conventional physical therapy program; A conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device.
Experimental: study group	Other: pressure biofeedback training; participants in study group will receive 30 mins and 3 sessions per week for 8 weeks; Other: conventional physical therapy program; A conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abdominal muscle strength	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	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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; pressure biofeedback; abdominal muscles strength
• Other Study ID Numbers: P.T.REC/012/006111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No