| CTRI Number |
CTRI/2025/07/090977 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In Our Study We Will Be Including Patients With Post Operative Open Abdominal Surgery. We Will Be Giving Virtual Reality Training Along With Conventional Therapy For Promoting Early Mobility And Pain Reduction. |
|
Scientific Title of Study
|
Feasibility of virtual reality training in promoting early mobility in patients following abdominal surgery: a pilot randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charul Dandale |
| Designation |
Post Graduate Student |
| Affiliation |
MGM Institute of Physiotherapy ,Aurangabad |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, MGM Institute of Physiotherapy Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9130898471 |
| Fax |
|
| Email |
charuldandale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Dobhal |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy ,Aurangabad |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, MGM Institute of Physiotherapy Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
santoshdobhal@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Dobhal |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy ,Aurangabad |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, MGM Institute of Physiotherapy Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
santoshdobhal@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Physiotherapy N6 CIDCO Aurangabad 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy ,Aurangabad |
| Address |
N6 CIDCO Aurangabad 431003 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Charul Dandale |
MGM Medical College and Hospital |
Department of Cardiovascular and Respiratory Physiotherapy MGM Institute of Physiotherapy N6 CIDCO Aurangabad 431003
Aurangabad
MAHARASHTRA |
09130898471
charuldandale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Care |
1.Pain Management.
2.Breathing Exercises
3.Range of Motion Exercises.
4.Strengthening Exercises.
5.Functional Training Exercises.
20 mins for 1 Week per day
|
| Intervention |
Virtual Reality Training Group |
1.Maloka Game
Instructing the participants to inhale deeply through the nose and exhale slowly through the mouth. Then will highlight the goal of this activity is to reduce stress and improve breathing control.
2.First Steps Game
In this game the basic VR interactions, such as picking the objects, pressing buttons, and reaching for virtual elements.
20 mins for 1 Week per day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Aged 18 to 65 years undergoing open abdominal surgery.
2.Hemodynamically stable patient and cleared for early mobilization by the surgical team.
3.Willing to participate and provide informed consent.
4.Cognitive ability to follow Virtual Reality based rehabilitation instructions.
|
|
| ExclusionCriteria |
| Details |
1.Patients with neurological disorders affecting mobility (e.g. stroke, Parkinson’s).
2.Severe postoperative complications (e.g., sepsis, hemodynamically unstable).
3.Cognitive impairments or psychiatric conditions affecting VR interaction.
4.Visual or vestibular disorders that may interfere with VR training.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Perme ICU mobility scale
2.System Usability Scale |
Pre and Post Intervention (1 week) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Analog Scale (VAS)
2. Borg rating of perceived exertion |
Pre and Post Intervention (1 week) |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Our Study We Will Be Including Patients with Post Operative Open Abdominal Surgery. We Will Be Giving Virtual Reality Training Along with Conventional Therapy for Promoting Early Mobility and Pain Reduction. Patients with open abdominal surgery will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained. Demographic data will be noted. Baseline data which include PERME ICU mobility scale, Visual Analogue Scale, Borg rating of perceived exertion, System Usability Scale will be assessed. The patients will be randomly divided into two study groups intervention group and control group. The patients will receive intervention as per the group allocation for 1 week. The intervention group will receive Virtual Reality Training Exercises whereas the control group will receive conventional care physiotherapy only. VR Training involve games maloka and first step game will be given 7 session/week for 1 week. Conventional Physiotherapy Includes Pain Management, Breathing Exercises, Range of Motion (ROM) Exercises, Strengthening Exercises, Stretching Exercises, Functional Training will be given 7 sessions/week for 1 week. All participants will be receiving one session of 30-40 minutes per day. Outcome measures will be assessed pre and post intervention period. Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study.
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