| 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
|
|
|
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
|
|
|
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. |