| CTRI Number |
CTRI/2025/08/092164 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Testing of a game based exercise program for patients in ICU |
|
Scientific Title of Study
|
Implementation of Virtual Reality-based Mobilization Program for Critically-ill patients: A Feasibility Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Vaishanavi Shetty |
| Designation |
Post Graduate Student - MPT |
| Affiliation |
Manipal College of Health Professions, Manipal College of Higher Education Manipal |
| Address |
Department of Physiotherapy, Room 215, Manipal College of Health Professions, Manipal College of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6363292544 |
| Fax |
|
| Email |
vaishanavi.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Anup Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions, Manipal College of Higher Education Manipal |
| Address |
Department of Physiotherapy, Room 204, Manipal College of Health Professions, Manipal College of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9916820026 |
| Fax |
|
| Email |
anup.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abraham Samuel Babu |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions, Manipal College of Higher Education Manipal |
| Address |
Department of Physiotherapy, Room 209, Manipal College of Health Professions, Manipal College of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9742502838 |
| Fax |
|
| Email |
abraham.babu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, 2nd floor, room no. 215, Manipal College of Health Professions, Manipal College of Higher Education, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Vaishanavi Shetty |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal College of Higher Education, Manipal, Karnataka, India, 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Shanbhag |
Kasturba Hospital |
ICU1,ICU 2, ICU 3, MF3 HDU, D2HDU, Department of Critical Care Medicine, Udupi- Hebri road, Madhav Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
9914201838
vishal.shanbhag@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, (2) ICD-10 Condition: G729||Myopathy, unspecified, (3) ICD-10 Condition: R538||Other malaise and fatigue, (4) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
There is no comparator. it is a single group, pre-post, feasibility study |
| Intervention |
Virtual reality-based mobilization program |
The intervention is a virtual reality game based mobilization program. As a replacement to traditional mobilization program consisting of exercises, this game will be used to provide exercises. Patients will receive a minimum of two to a maximum of five sessions during their ICU stay(except Sundays) or HDU. During the initial session the patient will be given a trial session of 10-15 mins to get adjusted and comfortable with the device. The entire session will last for 5-15minutes (depending on patient’s hemodynamic stability). As the sessions progress, each session can go up to a maximum of 30 minutes. Therapy will be delivered in the presence of two physiotherapists trained in using the virtual reality system. Activities will initially be performed in bed and will then gradually progress, based on the patient’s hemodynamic stability, to the edge of bed and eventually out of bed. Adequate rest periods will be provided. All interventions will be titrated to ensure a moderate intensity. The device will be disinfected using antibacterial wipes before and after the use. Session will be terminated if: the patient asks to stop, drop in systolic blood pressure more than 10mmHg; heart rate less than 50 bpm or more than 140 bpm, Oxygen saturation level drop i.e. less than 90%, Altered level of consciousness, Increased pain or level of discomfort, Symptoms of nausea, distress, agitation, Patient exhibits extreme fatigue or inability of continue, Dislodgment of any drains or tubes, Technical issues: poor fit, VR system malfunction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Duration of stay in ICU: more than 48 hours
Breathing spontaneously with or without an advanced airway
Must follow 5 standardized questions for co-operation.
(Open and close your eyes, look at me, open your mouth and put out your tongue, nod your head, raise your eyebrow after I have counted to five)
Can functionally communicate
Muscle power of at least 3 in both upper limbs
Functional vision and hearing
|
|
| ExclusionCriteria |
| Details |
Known psychiatric disorders
Infectious skin conditions, non-healing pressure sores on occiput or sacrum
Patients with contact precautions
Hemodynamic instability
Non-Invasive ventilation
Nausea while travelling
Untreated DVT
Neurological conditions limiting movements of the upper or lower limb
History of seizures, Headache, Migraine
Uncontrolled hypertension
Pregnancy
Untreated or just treated (less than 14 days) fractures that prevent a person from moving upper limbs/using the VR controllers
Recent MI (less than 3 days) and not revascularized,
Unstable angina
Untreated arrythmias
Musculoskeletal Pain; NPRS more than 5
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Feasibility will be assessed using Bowen framework.
Acceptability will be assessed using Theoretical framework of acceptability scale on 5-point Likert scale.
Usability will be assessed using System usability scale on 5-point Likert scale .
|
On the day of shift from HDU To wards
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscle Strength will be assessed using Medical Research Council (MRC) sum score. It consists of grade 0 to 5.
Mobility will be assessed using John Hopkins Highest Level of Mobility scale. It has 8 Levels.
ICU Delirium will be assessed using The Confusion Method for the Intensive Care Unit (CAM-ICU). It is a 4 item scale
Physical function will be assessed using Physical function ICU test –scored (PFIT-s). It has 4 components.
|
Beginning of the study, before and after each session of intervention, and on the day of shift from HDU to wards |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This
will be an interventional study. This study will
evaluate the feasibility of using a virtual reality-based mobilization program
in critically ill patients admitted to ICU2, ICU3 and MF3 HDU.
Patients will be
assessed for muscle strength, ICU delirium and level of mobility using MRC sum
score, CAM-ICU and John Hopkins level of mobility scale respectively. Patients
will receive one session of the virtual reality intervention along with
standard care everyday till the day they are shifted to the wards. Patients
will be monitored to ensure safety throughout the procedure.
|