Effect of mobile app enabled facial muscle exercises and behaviour modification program on oral health status among children with Cerebral Palsy.
- Conditions
- 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,
- Registration Number
- CTRI/2021/03/031990
- Lead Sponsor
- Mihir Nayak
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 184
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improvement in oral motor functions in children with CP 6 months 2.Improvement in oral hygiene in children with CP 6 months
- Secondary Outcome Measures
Name Time Method Improvement in oral hygiene in children with CP Decreased stress and increased coping levels among parents/caretakers of children with CP 6 months
Trial Locations
- Locations (1)
Department of Pediatric and Preventive Dentistry
🇮🇳Bangalore, KARNATAKA, India
Department of Pediatric and Preventive Dentistry🇮🇳Bangalore, KARNATAKA, IndiaMihir NayakPrincipal investigator8951415097mihirnn7@hotmail.com