Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

NCT ID: NCT06301126

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-07-01

Brief Summary

After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain.

Detailed Description

Virtual reality (VR) encourages an environment that attempts to create a moment of entertainment, motivation, and enjoyment with a variety of stimuli, with movements that stimulate physical and cognitive development, as well as the patient's active participation in the rehabilitation process. It is possible to assist in the alleviation of pain using the platform, at a low cost, through the playfulness given during rehabilitation, with an effective consumption of oxygen, range of motion, and use of the respiratory muscles more efficiently.

Participants with upper abdominal surgery will be randomly distributed into Group A (VR Group) which will receive VR for plus conventional physical therapy program and Group B (Control Group) which will receive conventional physical therapy program.

Conditions

Abdomen Hernia; Respiratory Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual reality

Participants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

The system included an Xbox 360® console, a sensor that detects motion (Kinect®), and a projector device with loudspeakers. The console, which was mounted on a table, reached 1 m tall. The Kinect® motion sensor was attached to the projector, which showed images onto a wall 2.5 metres distant from the playing field. The playing field was at least 1.8 m wide and 1.8 m long, with the Kinect® sensor situated 1.2 m away. The device was calibrated before each training session to accurately follow the motions of each subject.

conventional physical therapy exercise program

Intervention Type: OTHER

Participants will receive conventional physical therapy exercise program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

Control

Participants will receive conventional physical therapy program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

Group Type: ACTIVE_COMPARATOR

conventional physical therapy exercise program

Intervention Type: OTHER

Participants will receive conventional physical therapy exercise program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

Interventions

Virtual reality

The system included an Xbox 360® console, a sensor that detects motion (Kinect®), and a projector device with loudspeakers. The console, which was mounted on a table, reached 1 m tall. The Kinect® motion sensor was attached to the projector, which showed images onto a wall 2.5 metres distant from the playing field. The playing field was at least 1.8 m wide and 1.8 m long, with the Kinect® sensor situated 1.2 m away. The device was calibrated before each training session to accurately follow the motions of each subject.

Intervention Type: OTHER

conventional physical therapy exercise program

Participants will receive conventional physical therapy exercise program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients undergone open upper abdominal surgery (hernia repair, cholecystectomy, large bowel removal, conventional laparotomy)

2. no prior surgical intervention for esophageal, gastric, or biliary tract resection

3. age 18-60 years

4. acceptable physical condition (permitting pulmonary function and functional capacity test).

Exclusion Criteria

1. Cerebrovascular disease

2. use of immunosuppressants within 30 days of surgery

3. cardiovascular instability

4. chest physical therapy within the 8 weeks preceding study enrollment

5. visual impairment or hearing impairment;

6. bed-ridden patients;

7. any lung disorders

8. insulin-dependent diabetes mellitus

9. less than 6-months post thoracic or cardiac surgery

10. musculoskeletal impairment

11. cognitive disorders

12. Patients undergoing laparoscopic surgery as this induces smaller changes in the postoperative breathing mechanics than laparotomy does

13. heavy smokers or alcoholism

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadaya M Eladl, PhD

Role: STUDY_CHAIR

Assistant professor of physical therapy for surgery, Faculty of physical therapy

Nabil M Abdel-Aal, PhD

Role: STUDY_DIRECTOR

Assistant professor of physical therapy for basic sciences, Faculty of physical therapy

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004985

Identifier Type: -

Identifier Source: org_study_id