Effect of Pressure Biofeedback Training After Ventral Hernioplasty

NCT07642219 | Completed

• 1 other identifier: P.T.REC/012/006111
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia Repair

Keywords

pressure biofeedback; quality of life; abdominal muscles strength

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

study group

EXPERIMENTAL

Other: pressure biofeedback training; Other: conventional physical therapy program

control group

ACTIVE COMPARATOR

Other: conventional physical therapy program

Interventions

pressure biofeedback training OTHER

participants in study group will receive 30 mins and 3 sessions per week for 8 weeks

study group

conventional physical therapy program OTHER

A conventional physical therapy program will include abdominal muscle strengthening without pressure biofeedback device.

control group; study group

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start: October 6, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

EG (1)