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CTRI Number  CTRI/2024/03/063762 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 10/08/2024
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   Virtual Reality and Balance: Helping Kids with Cerebral Palsy 
Scientific Title of Study   Development of a Customized Non-Immersive Virtual Reality System as a Therapeutic Tool for Children with Cerebral Palsy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Agrawal Luckykumar Dwarkadas  
Designation  Research Scholar 
Affiliation  National Institute of Teachers Training and Research, Chandigarh 
Address  National Institute of Technical Teachers Training and Research, Sector 26, Chandigarh, 160019, India.

Chandigarh
CHANDIGARH
160019
India 
Phone  9890797601  
Fax    
Email  luckykumar.cse21@nitttrchd.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Krishna Challa 
Designation  Professor & Head  
Affiliation  National Institute of Teachers Training and Research, Chandigarh 
Address  National Institute of Technical Teachers Training and Research, Sector 26, Chandigarh, 160019, India.

Chandigarh
CHANDIGARH
160019
India 
Phone  9417494811  
Fax    
Email  rkc@nitttrchd.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Nishad Kassim  
Designation  Physiotherapist, Director, Health and Rehabilitation  
Affiliation  The Association of People with Disability (APD), Bangalore 
Address  The Association of People with Disability (APD), 6th Cross Hutchins Road, Off Hennur Road, Lingarajapuram, St Thomas Town Post, Bangalore-Karnataka 560084

Chandigarh
CHANDIGARH
160019
India 
Phone  9633739775  
Fax    
Email  nishadk@apd-india.org  
 
Source of Monetary or Material Support  
No Funding 
 
Primary Sponsor  
Name  Dr Rama Krishna Challa 
Address  National Institute of Technical Teachers Training and Research, Sector 26, Chandigarh, 160019, India. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Nishad Kassim  Association of People with Disability (APD), 6th Cross Hutchins Road, Off Hennur Road, Lingarajapuram, St Thomas Town Post, Bangalore-Karnataka 560084. 
Dr Viswanath Talasila  Ramaiah Institute of Technology, MSR Nagar, Bengaluru, 560054, India. 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Agrawal Luckykumar Dwarkadas  National Institute of Technical Teachers Training and Research  National Institute of Technical Teachers Training and Research, Sector 26, Chandigarh, 160019, India
Chandigarh
CHANDIGARH 		 9890797601
91-172-2792369
luckykumar.cse21@nitttrchd.ac.in 
Dr Nishad Kassim  The Association of People With Disability (APD)  The Association of People with Disability (APD), 6th Cross Hutchins Road, Off Hennur Road, Lingarajapuram, St Thomas Town Post, Bangalore-Karnataka 560084.
Bangalore
KARNATAKA 		 9633739775
080-25470390
nishadk@apd-india.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Panjab University (PUIEC)  Approved 
The Association of People with Disability   No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Activity-Oriented Virtual Reality Training Along with Standard Physiotherapy  Virtual Reality Training Through Wearable IMU Sensors for Balance and Stepping, Speaker, Projector. Functional-Based Balance Training, Such as Trunk Control, Balance Reaction, and Bilateral Integration. Total Duration: Three 90-Minute Sessions Per Week for a Total of 8 Weeks. 
Comparator Agent  Standard Physiotherapy  Functional-Based Balance Training: Trunk Control - Swiss Ball/Bolster Hip Strategies, Trunk Strengthening. Balance Reaction - Perturbations, Balance Disc Activities, Stepping Strategies. Bilateral Integration - Bimanual Tasks with Balancing Reactions. Total Duration: Three 90-Minute Sessions Per Week for a Total of 8 Weeks. 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1) 7 to 15 years of cerebral palsy (CP) kids, male or female, with spastic diplegia. 2) GMFC level 2 classification. 3) Able to understand verbal instructions and cooperate while playing the game. 4) Ability to stand and walk. 5) Kids whose parents and guardians sign the consent form. 
 
ExclusionCriteria 
Details  1) Participants who do not wish to play the virtual reality game. 2) Any orthopedic surgery in the last 3 – 6 months. 3) Treated with Botox in the last 3/6 months. 4) Any other co-morbidities 5) Unable to follow 2-step instructions. 6) Any associated behavioral problems. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pediatric Balance Scale, Dyanamic balance, Intrinsic Motivation Inventory (IMI), Inertial Measurement Unit (IMU) Sensor data   0 Week, End of 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Functional independence  0 Week, End of 8th week 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/03/2024 
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="3"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [luckykumar.cse21@nitttrchd.ac.in].

  6. For how long will this data be available start date provided 15-09-2024 and end date provided 15-09-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This research study is a single-blinded, randomized, controlled trial conducted to compare the effects of conventional therapy and VR training on functional mobility and balance in children with cerebral palsy who are reported with walking and balancing difficulties. The study will involve 32 participants utilizing wearable sensors to interact with VR games during 45-minute sessions three times a week for up to 8 weeks. The primary outcome measures will be the Pediatric Balance Scale (PBS), Intrinsic Motivation Inventory (IMI), and sensor data. The secondary outcome will be the functional independence of children. The assessment scales will be performed on the first day and at the end of total therapy sessions. This research will help understand the children’s current balance and coordination abilities. Further, training the child using this device will enhance the children’s balance, coordination, and motivation. The results of this study will benefit children with cerebral palsy by improving ambulation, motivation to sustain activities, and functional balance.
 
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