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CTRI Number  CTRI/2021/03/031990 [Registered on: 15/03/2021] Trial Registered Prospectively
Last Modified On: 11/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Screening
Dentistry
Behavioral
Other (Specify) [Oral Motor Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of mobile app enabled facial muscle exercises and behaviour modification program on oral health status among children with Cerebral Palsy. 
Scientific Title of Study   Evaluation of efficacy of app based oral motor therapy and behaviour therapy in improving functions of oral musculature and oral hygiene in children with Cerebral Palsy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mihir Nayak 
Designation  PhD Research Scholar 
Affiliation  Government Dental College and Research Institute Bengaluru 
Address  Department of Pediatric and Preventive Dentistry Government Dental College and Research Institute Victoria Hospital campus Near City Market Kalasipalyam Bengaluru Karnataka 560002
Dr Mihir Nayak Reader Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital Chola Nagar R T Nagar Post Hebbal Bengaluru Karnataka 560032
Bangalore
KARNATAKA
560002
India 
Phone  8951415097  
Fax    
Email  mihirnn7@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SK Srinath  
Designation  Professor and HOD 
Affiliation  Government Dental College and Research Institute Bengaluru 
Address  Department of Pediatric and Preventive Dentistry Government Dental College and Research Institute Victoria Hospital campus Near City Market Kalasipalyam Bengaluru Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9845592166  
Fax    
Email  srinath.krishnappa@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Mihir Nayak 
Designation  PhD Research Scholar 
Affiliation  Government Dental College and Research Institute Bengaluru 
Address  Department of Pediatric and Preventive Dentistry Government Dental College and Research Institute Victoria Hospital campus Near City Market Kalasipalyam Bengaluru Karnataka 560002
Dr Mihir Nayak Reader Department of Pediatric and Preventive Dentistry Sri Rajiv Gandhi College of Dental Sciences and Hospital Chola Nagar R T Nagar Post Hebbal Bengaluru Karnataka 560032
Bangalore
KARNATAKA
560002
India 
Phone  8951415097  
Fax    
Email  mihirnn7@hotmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry Government Dental College and Research Institute Bengaluru 
 
Primary Sponsor  
Name  Mihir Nayak 
Address  Department of Pediatric and Preventive Dentistry Government Dental College and Research Institute Victoria Hospital campus Near City Market Kalasipalyam Bengaluru Karnataka 560002  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mihir Nayak  Department of Pediatric and Preventive Dentistry  Government Dental College and Research Institute Bengaluru
Bangalore
KARNATAKA 
8951415097

mihirnn7@hotmail.com 
Mihir Nayak  Department of Pediatric and Preventive Dentistry  Sri Rajiv Gandhi College of Dental Sciences and Hospital Bengaluru
Bangalore
KARNATAKA 
8951415097

mihirnn7@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethical Committee Sri Rajiv Gandhi College of Dental Sciences and Hospital Bengaluru  Approved 
Institutional Ethical Committee Government Dental College and Research Institute Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G800||Spastic quadriplegic cerebral palsy, (2) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, (3) ICD-10 Condition: G808||Other cerebral palsy, (4) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, (5) ICD-10 Condition: G803||Athetoid cerebral palsy, (6) ICD-10 Condition: G804||Ataxic cerebral palsy, (7) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  App based Oral Motor Therapy  Oral Motor exercises would be delivered for a period of six months using a mobile app developed for the purpose. Oral motor exercises would be delivered by a trained and certified oral motor/oral placement therapist/speech therapist. Parents or caretakers would assist their children diagnosed with Cerebral Palsy (with oro-motor problems) in following the exercises. Oro-motor tools may or may not be used while enabling the exercise sessions. 
Comparator Agent  Behaviour Therapy(Behaviour modification program)  Behaviour Therapy would be delivered for a period of six months by a trained behaviour therapist. Parents or caretakers would assist their children diagnosed with Cerebral Palsy (with oro-motor problems) in following the behaviour modification program schedules/instructions.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1.Patients/children certified by physician or specialist doctor of having Cerebral Palsy (with oral motor problems)
2.Those children whose parents/caretakers provide a written informed consent (and assent from children when possible)
3.Those who answer positively of having at least one or more problems of oral motor functions such as drooling or swallowing or feeding
 
 
ExclusionCriteria 
Details  1. Non participation for more than two sessions
2. Children who might have seizures or any medical conditions that prevents daily activity and oral motor therapy
3. Children who are on medications for drooling
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in oral motor functions in children with CP
2.Improvement in oral hygiene in children with CP
 
6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in oral hygiene in children with CP
 
6 months 
Decreased stress and increased coping levels among parents/caretakers of children with CP  6 months 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2021 
Date of Study Completion (India) 27/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This study is a randomized, double blinded, parallel group, multicentre trial evaluating the efficacy of app based oral motor therapy and behaviour therapy in improving functions of oral musculature and oral hygiene in children with Cerebral Palsy(CP). Written informed consent from parents/caretakers (and assent whenever possible) would be taken. The children with CP aged 4 to 14 years would be recruited from the different special child care schools and centres providing care for special health care needs children in Bengaluru. They will also be recruited from among the patients who visit the Department of Pediatric and Preventive Dentistry of the dental college in Bengaluru where the ethical clearance has been procured. The mobile app meant for the study would be developed with the help of software professionals. The children would be randomly allocated to the two groups, one group being the app based oral motor therapy; the other group being the behaviour therapy. App based oral motor therapy and behaviour therapy (behaviour modification program) would be delivered over a period of 6 months, through trained respective therapists. Baseline and 6 month evaluation of oral motor dysfunctions, oral hygiene status, stress and coping levels of parents/caretakers would be performed. If feasible, the same children can be followed up till end of one year from the commencement of intervention, to observe the benefits rendered. The primary outcome measures would be improvement in oral motor functions and oral hygiene among children with Cerebral Palsy. Secondary outcome measures would be decreased stress and increased coping levels among parents/caretakers of children with Cerebral Palsy.
 
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