| 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
|
|
|
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
|
|
|
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. |