| CTRI Number |
CTRI/2025/11/097550 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| 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
|
Use of virtual reality with physiotherapy to improve memory and thinking in cancer patients receiving chemotherapy |
|
Scientific Title of Study
|
Effectiveness of virtual reality as an adjunct to conventional physiotherapy for cognitive impairments in patients undergoing chemotherapy: A 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 Renuka Bhavsar |
| Designation |
PG Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy center, Department of Neurophysiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8180097826 |
| Fax |
|
| Email |
renukabhavsar0092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renuka Bhavsar |
| Designation |
PG Student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy center, Department of Neurophysiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8180097826 |
| Fax |
|
| Email |
renukabhavsar0092@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical research Center, Room no. 39, Sagar Floor, Advanced Physiotherapy center, Department of Neurophysiotherapy, Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Nehru nagar, Belagavi - 590010, Karnataka India |
|
|
Primary Sponsor
|
| Name |
Renuka Bhavsar |
| Address |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherpy, Belgaum 590010, Karnataka, India |
| 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 Renuka Bhavsar |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Bekagavi |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Center, Room
no. 39, Sagar Floor, Advanced physiotherapy center, Department of
Neurophysiotherpy, Belgaum, Karnataka
Belgaum
KARNATAKA |
8180097826
renukabhavsar0092@gmail.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: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Training frequency- 5 sessions a week Training duration- 30 minutes Number of weeks- 2 weeks Exercises- 30 mins per sessions
Total duration: 30 mins |
| Intervention |
Virtual reality + conventional physiotherapy |
Training frequency- 5 sessions a week
Training duration of virtual reality- 30 minutes
Number of weeks- 2 weeks
Exercises- 30 mins per sessions
total duration 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with cancer for the first time undergoing chemotherapy in the age group of 18-75 years of both genders, willing to participate.
2. Medically stable individuals.
3. Cognitive impairment score ranging from 10-24 according to MMSE.
|
|
| ExclusionCriteria |
| Details |
1. Patients receiving other forms of psychotherapy.
2. Patients having the following conditions- apraxia, neglect, aphasia or any visual impairments.
|
|
|
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 |
1.Distress thermometer
2.FACT – Cog
3.Mini-Mental State Examination
4.EORTC QOQ C30 |
Baseline and post intervention [ after 2 weeks] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2025 |
| Date of Study Completion (India) |
08/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 randomized controlled trial will evaluate the effectiveness of virtual reality (VR) as an adjunct to conventional physiotherapy in reducing chemotherapy-related cognitive impairment (CRCI) among cancer patients. CRCI, also known as “chemo brain,” affects memory, attention, and executive function, leading to reduced quality of life. A total of 26 participants aged 18–75 years with MMSE scores between 10–24 will be randomly assigned to receive either conventional physiotherapy alone or physiotherapy combined with VR-based training for two weeks. Outcome measures including Mini-Mental State Examination (MMSE), Functional Assessment of Cancer Therapy–Cognitive Function (FACT-COG v3), Distress Thermometer, and EORTC QLQ-C30 will be assessed at baseline and post-intervention. The study aims to generate evidence on whether VR combined with physiotherapy provides superior improvements in cognition, psychological well-being, and quality of life compared to physiotherapy alone. |