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CTRI Number  CTRI/2024/02/063303 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment for improving stability in brain injured children  
Scientific Title of Study   Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation Techniques along with Virtual Game-based rehabilitation on overall balance in children with Spastic Diplegia-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 Rakesh Krishna Kovela 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy, NITTE(Deemed to be University). 
Address  Counter number 20, Basement Second Floor, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  rakesh.krishna@nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Krishna Kovela 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy, NITTE(Deemed to be University). 
Address  Counter number 20, Basement Second Floor, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  rakesh.krishna@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Krishna Kovela 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy, NITTE(Deemed to be University). 
Address  Counter number 20, Basement Second Floor, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  rakesh.krishna@nitte.edu.in  
 
Source of Monetary or Material Support  
Monetory and Material Support by NITTE(DEEMED TO BE UNIVERSITY), Deralakatte, Mangaluru, Karnataka, India 
 
Primary Sponsor  
Name  NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India 
Address  NITTE (Deemed to be University), 6th floor, University complex, Deralakatte, Mangaluru, Karnataka, India 
Type of Sponsor  Other [Constituent Physiotherapy Institute of NITTE(Deemed to be University)] 
 
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 Rakesh Krishna Kovela  Justice K S Hegde Charitable Hospital, NITTE(Deemed to be University)  Department of Physiotherapy, Counter Number 20, Basement second Floor, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA 		 7204346274

rakesh.krishna@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nitte Institute of Physiotherapy, Institutional Ethics Committee  Approved 
 
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 
Comparator Agent  Conventional Physiotherapy Program   Control group will be receiving conventional physiotherapy program for 45 minutes a day for 5 days a week for 6 weeks. The conventional physiotherapy includes stretching of tightened musculature and strengthening of weak musculature 
Intervention  Pelvic PNF, Virtual Game based rehabilitation and Conventional Physiotherapy   Intervention group will be receiving Pelvic PNF, Rhythmic initiation, Slow reversal and Stabilizing reversal14 10 repetitions each, for 15 minutes (bilaterally) along with 15 minutes of game-based rehabilitation using Nintendo wii fit and also 15 minutes of conventional physiotherapy for a total of 45 minutes a day, 5 days per week for 6 weeks  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1) Children diagnosed with Spastic CP of either gender
2) Children from 4 to 9 years of age
3) Children with pelvic asymmetry
4) Children with Gross Motor Functional Classification System level I to III
5) Children who can and cannot Sit Independently
6) Children who are able to follow commands (Pediatric MMSE greater than or equal to 22)
 
 
ExclusionCriteria 
Details  1) Children under botox medication in the last 6 months
2) Children who underwent any surgery involving spine and in past 6 months
3) Children having uncontrolled seizures since past 6 months
4) Children with fixed deformities or contractures in spine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Pelvic asymmetry through Palpation Meter Device (PALM)
2. Balance through Pediatric Balance Scale
3. trunk control through Segmental assessment of trunk control
4. Gross motor function through Gross Motor Function Measure GMFM-88
 		 On the day 1 and at the end of 6 weeks(Last day of 6th week)
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   Phase 1 
Date of First Enrollment (India)   01/04/2024 
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="2"
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   Aim of the study is to evaluate the effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation Techniques along with Exergaming based rehabilitation on static active and reactive sitting balance in children with Spastic CP. Primary Objective is to evaluate the effect of Pelvic Proprioceptive Neuromuscular Facilitation along with exergaming-based rehabilitation through Wii Fit on overall sitting balance in children with Spastic CP. To compare the effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation along with exergaming-based rehabilitation with conventional therapy on overall sitting balance in children with Spastic CP. Secondary Objective is to evaluate the effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation on pelvic asymmetry in children with Spastic CP. Scope of the study is Pelvic Proprioceptive Neuromuscular Facilitation along with game based rehabilitation can be an effective technique of rehabilitation in spastic CP children to improve their balance by targeting trunk control by effective Pelvic PNF and also game based rehabilitation in static, active and reactive balance training. Clinical implication of the study is, if the study is proved to be effective then training of pelvic control will become an active ingredient in treatment of children with cerebral palsy to improve static, active and reactive balance. 

Novelty:

Game based rehabilitation along with pelvic PNF will add additional benefits in Paediatric physiotherapy OPD and also in community rehabilitation setup. It adds to quality time spend by children in physiotherapy. 

 

 
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