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CTRI Number  CTRI/2024/07/071345 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
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   Enhancing Balance in Children with Spastic Cerebral Palsy Integrating Virtual Reality Therapy with Physiotherapy 
Scientific Title of Study   Added Effect of Virtual Reality Therapy along with Conventional Physiotherapy on Static and Dynamic Balance in children with Spastic 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  Rituja Malkhede 
Designation  PG student  
Affiliation  Maeers Physiotherapy College Talegaon Dabhade 
Address  MAEERS college of Physiotherapy OPD building 2nd floor Neurophysiotherapy department OPD no A 230 Talegaon Dabhade Pune , maval MAHARASHTRA 410507

Pune
MAHARASHTRA
410507
India 
Phone  9834375384  
Fax    
Email  rmalkhede99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sayli Paldhikar 
Designation  Professor 
Affiliation  Maeers Physiotherapy College talegaon dabhade 
Address  MAEERS college of Physiotherapy OPD building 2nd floor Neurophysiotherapy department OPD no A 230 Talegaon Dabhade Pune , maval

Pune
MAHARASHTRA
410506
India 
Phone  8805174616  
Fax    
Email  saylithuse@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sayli Paldhikar 
Designation  Professor 
Affiliation  Maeers Physiotherapy College talegaon dabhade 
Address  MAEERS college of Physiotherapy OPD building 2nd floor Neurophysiotherapy department OPD no A 230 Talegaon Dabhade Pune , maval


MAHARASHTRA
410506
India 
Phone  8805174616  
Fax    
Email  saylithuse@gmail.com  
 
Source of Monetary or Material Support  
MAEERS college of Physiotherapy OPD building 2nd floor Neurophysiotherapy department OPD no A 230 Talegaon Dabhade Pune , maval 
 
Primary Sponsor  
Name  Rituja Malkhede 
Address  Maeers Physiotherapy College Near Railway station 2nd floor neuro physiotherapy department cabin no A-230 Talegaon Dabhade 
Type of Sponsor  Private medical college 
 
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 Sayli Paldhikar   MAEERS COLLEGE OF PHYSIOTHERAPY TALEGOAN DABHADE PUNE   MAEERS college of Physiotherapy OPD building 2nd floor Neurophysiotherapy department OPD no A 230 Talegaon Dabhade Pune , maval
Pune
MAHARASHTRA 
8805174616

saylithuse@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maeers college of physiotherapy ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional balance exercise   Conventional protocol will be given stretching , for hamstring and tendoachilles. Functional training may exercises will be given . Positional transitions and proprioceptive exercises will be given . Vestibular gaze stability exercises will be given . Protocol will be given for 6 weeks 3times per week .  
Intervention  virtual reality  intervention name virtual reality virtual Reality is a sole program improves the static balance and dynamic balance in pediatric population virtual reality intervention has different games based on the type of balance we want to train for example to train static balance there is limits of stability drawn in which child has to stand and within his limits he has to play the game and if the child crosses his limits of stability then the game will pause there are different levels of game which can be progressed according their own progress similarly dynamic balance has also specific games which include running ,jumping has obstacle walking this will be incorporated with normal conventional balance training Protocol will be given for 6 weeks 3times per week . 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Spastic cerebral palsy Children having Gross Motor Function Classification Scale (GMFCS) level 2 to 3
2. Children with no hearing and vision loss. 
 
ExclusionCriteria 
Details  1. Children who are diagnosed with Choreoathetoid Cerebral
Palsy, Athetoid Cerebral Palsy, Ataxic Cerebral Palsy
2. Children who have cognitive impairment.
3. Children who are claustrophobic to Virtual Reality box even after the initial training period.
4. Children with fixed deformities in the lower extremities.
5. Children who have undergone any
musculoskeletal surgeries in the last 6
months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
static balance (limits of stability)neurocom balance master  pre and post intervention of 1.5 months 
 
Secondary Outcome  
Outcome  TimePoints 
dynamic balance (pediatric dynamic gait index scale)  pre and post intervention of 1.5 months 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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)   15/08/2024 
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 Applicable 
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  
Virtual Reality (VR) therapy is a recently popular assistive technology in the rehabilitation of children with Cerebral Palsy.It’s characteristic is that people can immerse themselves in a non-physical world through 3D displays at home. This immersive experience is in a safe and enjoyable environment, which may appeal to children, those with Cerebral Palsy. When children play games ,the actions involved,such as laughing, gesticulating and screaming, could enhance bioelectrical signals in the brain.The children will wear their usual footwear and orthoses during training.  Participants will be divided into two groups A and B by purposive  sampling and children will be treated with virtual reality therapy along with conventional physiotherapy. Group A - will be given Virtual Reality games along with conventional physiotherapy 3 times a week for 6 weeks (30 mins) Group B - will be given conventional physiotherapy 3 times a week for 6 weeks (30 - 45 mins)Progression in the Virtual Reality Therapy will be given according to the child’s improvement based on pre-interventional and post-interventional outcome scores, Limits of stability and Pediatric DGI for static balance and dynamic balance respectively, statistical analysis and results will be calculated. These treatment will be given for 3 sessions a week, each session of 30 minutes for 6 weeks Conventional protocol Conventional Physiotherapy :Treatment Method for control group and the experimental group :  Stretching techniques: Hamstrings,Tendoachilis,hip adductor. Functional training: (Mat exercises) Curl up,diagonal curl up ,bridging, prone on hands and elbows,quadruped positioN. Positional transitions  Proprioceptive training  with eyes opened  and closed - weight shifts   - forward reach, lateral reach ,diagonal reach. ‌Vestibular and gaze stability training - vestibulo -ocular reflex control Anticipatory and reactive postural control training  ‌Weight shifts training starts on floor, trampoline, balance disc, etc  ‌Perturbation training. Spot marching.
 
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