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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06301126
Other study ID # P.T.REC/012/004985
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 1, 2025

Study information

Verified date March 2024
Source Cairo University
Contact Nesma M Allam, PhD
Phone +201281968332
Email dr.nesma2011@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Other:
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.
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.

Locations

Country Name City State
Egypt Faculty of Physical Therapy Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced vital capacity (FVC) FVC will be measured by using spirometer. 8 weeks
Secondary Forced expiratory volume in 1 second (FEV1) FEV1 will be measured by using spirometer. 8 weeks
Secondary Peak expiratory flow (PEF) PEF will be measured by using spirometer. 8 weeks
Secondary Respiratory muscle strength The inspiratory muscle strength will be verified by means of the maximum inspiratory pressure (MIP) and the expiratory muscular strength by means of maximum expiratory pressure (MEP) by using the digital Manovacuometer. 8 weeks
Secondary diaphragmatic mobility Diaphragmatic mobility will be assessed using a high resolution ultrasound machine with a convex probe of 3.5 MHz on the right subcostal area in perpendicular incidence to craniocaudal axis in the assessment. 8 weeks
Secondary Functional capacity Functional capacity will be measured by using 6-Minute Walk Test (6-MWT) that measures the maximum distance walked in a period of 6 min to assess the submaximal level of the functional capacity of the participants. 8 weeks
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