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
|
|
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
|
|
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. |