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CTRI Number  CTRI/2025/10/095847 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Using Virtual Reality and Special Joint Exercises to Help Ease Pain and Tiredness, and Support Daily Life in People Receiving Chemotherapy: A Study with Randomly Selected Participants. 
Scientific Title of Study   Effect of Immersive Virtual Reality and Close Kinematic Chain Exercises on Pain, Fatigue and Quality of Life in Patients under going Chemotherapy: A Randomized Control 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  Rishabh Amit Shah 
Designation  Post Graduate  
Affiliation  KLE Institute of Physiotherapy 
Address  Room no 39 Advance physiotherapy center sagar floor Dr Prabhakar Kore hospital Nehru Nagar Belagavi Karnataka India

Belgaum
KARNATAKA
590010
India 
Phone  08149173711  
Fax    
Email  shahrishabh332@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjiv Kumar 
Designation  Principal and Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  Room no 39 Advance physiotherapy center sagar floor Dr Prabhakar Kore hospital Nehru Nagar Belagavi Karnataka India

Belgaum
KARNATAKA
590010
India 
Phone  09448745648  
Fax    
Email  sanjiv3303@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Sanjiv Kumar 
Designation  Principal and Professor 
Affiliation  KLE Institute of Physiotherapy 
Address  Room no 39 Advance physiotherapy center sagar floor Dr Prabhakar Kore hospital Nehru Nagar Belagavi Karnataka India

Belgaum
KARNATAKA
590010
India 
Phone  09448745648  
Fax    
Email  sanjiv3303@rediffmail.com  
 
Source of Monetary or Material Support  
KLEs Dr Prabhakar Kore Hospital and Medical Research Center, 590010 
 
Primary Sponsor  
Name  Rishabh Shah 
Address  Room no 39 Advance physiotherapy center sagar floor Dr Prabhakar Kore hospital Nehru Nagar Belagavi Karnataka India, 590010 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjiv Kumar  KLE Cancer Hospital  KLEs Dr Prabhakar Kore Hospital & Medical Research Centre NH Service Road Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA 
09448745648

sanjiv3303@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z511||Encounter for antineoplastic chemotherapy and immunotherapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Close Kinematic Exercises  15 sessions over 4 weeks of only close kinematic exercise Terminal knee extension exercise, lateral step-ups, wall squats, side stepping, standing heel raise - single leg for 10 repetition for 2 sets. 
Intervention  Virtual Reality + Close Kinematic Chain Exercise  15 sessions over 4 weeks of Virtual Reality via Head Mount for 20 minutes and Close kinematic chain exercise such Terminal knee extension exercise, lateral step-ups, wall squats, side stepping, standing heel raise - single leg for 10 repetition for 2 sets. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aging between 18-60 years including both Male and Female patients who are undergoing Chemotherapy. Karnofsky Performance Status Scale for functional mobility in patients undergoing chemotherapy 
 
ExclusionCriteria 
Details  Patient with Epilepsy
Addictions to contraband substances
Unstable Hypertension
Diagnosed cases of Cognitive impairment
Physical Impairment of Vision, Hearing
Bedridden Patients
Patients with Lower Limb Cancer  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
FACT - G Scale
 
15 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale
Brief Fatigue Inventory Scale 
20 minutes 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   N/A 
Date of First Enrollment (India)   20/11/2025 
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 Yet Recruiting 
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  

Chemotherapy is a medical treatment which aims to inhibit cell proliferation and tumor multiplication, thus avoiding invasion and metastasis via many ways of drug administration such as orally, intravenously, subcutaneously, intramuscularly, or intrathecal.Worldwide approximately 63% of patients diagnosed with cancer receive chemotherapy as a treatment approach which can further increase by 67% by the year 2040.Virtual Reality refers to a particular technological system, which includes a computer capable of providing interactive three-dimensional visualization, a controller for interaction with the animations, a position tracker, and a head-mounted display to deliver the visual output. Virtual reality mainly has 2 types: Immersive VR and Non-Immersive Virtual Reality. Immersive Virtual Reality is done by using head mounted set with help of mobile phone and plays different Audio and Video clip ,VR offers an immersive and interactive environment that fosters a sense of presence and transports individuals to a different reality, potentially reducing anxiety and pain perception.In Close Chain kinematic Exercise, the proximal component of the limb moves throughout the exercise, while the distal part remains stationary , CKC exercises improve overall functional mobility and lower the risk of falls, strengthens muscles, improves neuromuscular control & proprioception, and stabilizing joints and enhancing muscle coordination. So, with the help of the traditional close kinematic chain exercise we add the new Immersive Virtual Reality as treatment approach for relieving the pain and fatigue in patients.

 
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