| CTRI Number |
CTRI/2023/06/053670 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development & evaluation of a device for feeding & swallowing improvement in cerebral palsy children |
|
Scientific Title of Study
|
Development & Evaluation of Neuromuscular Electrical Stimulation & Vibrator Device in Improvement of Feeding and Swallowing and Reduction in Drooling among Cerebral Palsy children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Gurunathan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry ,Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Gurunathan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry ,Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Gurunathan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry ,Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
deepag@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Deepa Gurunathan |
| Address |
Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospital, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai 600077 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Deepa Gurunathan |
Saveetha Dental College and Hospital |
Clinic number 28, Department of Pediatric and Preventive Dentistry
Chennai
TAMIL NADU |
9994619386
deepag@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F809||Developmental disorder of speech and language, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle vibrator (Cro system) |
It is an electromechanical transducer with a particular mechanical support; used at a low amplitude rMV at a fixed frequency of 100Hz. To be used for 8 weeks |
| Intervention |
New device having vibrator and electric components |
The new device will have a regularised monitored discharge of electric stimulus and a mode to produce vibrations. Vibration and electric stimulus to be used on alternate days for a total period of 8 weeks. Route of administration is through the placement of electrodes (for electric stimulus) and through a electromechanical transducer (for the vibratory stimulus) |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
 Score below 10 in baseline The Oral Motor Assessment Scale (OMAS)
Willingness of participation of parents in more than 80% of the whole process
Have no experience of Stimulation therapy
Children without head and neck control problems
Children with no audible, visible perceptual deficiency. |
|
| ExclusionCriteria |
| Details |
Children with history of seizures.
Children on tube feeding and have a history of aspiration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| tone,strength & coordination of oro facial muscles |
pre treatment & post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| activity of orofacial muscles |
pre treatment & post treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cerebral palsy (CP) is the commonest neurodevelopmental disorder of childhood because of a non-progressive damage to the brain, which leads to various activity limitations caused by progressive postural and movement disturbances. Globally it is reported that the prevalence range of CP is from 1.5 to 4 per 1000 live births , however the prevalence range reported for India is higher ranging from 2.08 to 3.88 per 1000 live births.Parents and families of CP children experience an higher levels of stress and depression and, have a lower quality of life as compared to parents of healthy children. In addition ,CP also affects oral motor skills, leading to speech delay, drooling and difficulties with sucking, swallowing, and chewing.Inability to chew leads to retarded growth and development, while drooling becomes a major hindrance in social development. Children with CP also encounter dental caries, dental trauma, malocclusion, and compromised periodontal status due to their insufficient neuromuscular activity.Due to reduced neuromuscular control an higher incidence of sleep disorder breathing including obstructive sleep apnea is observed in children with Cerebral Palsy Aims & objective with reason Reason: Sensory application such as electric stimulation and high frequency vibrations have shown to improve the strength of oral and masticatory muscles aiding in reduction of drooling and improving swallowing and chewing.The need of the hour is for a device that is economical and which be used diligently by parents at home. Therefore this instrument will have an beneficial effect on functional independence level and improving the quality of life of children with Cerebral Palsy. Aim: To develop an unique indigenous device that gives electrical stimulation and vibration that will enhance the strength,coordination and activity of oro facial muscles in CP children. To compare the improvement in the tone, strength, coordination and activity of oro facial muscles with the existing professional equipment that is used for management of CP children Objective To develop a device to improve the tone, strength,coordination and activity of oro facial muscles among children with CP. To use the instrument in children with CP aged 3 to 6 year and evaluate the improvement in the tone, strength,coordination using surface electromyography and activity of oro facial muscles. To evaluate the improvement in the tone, strength,coordination using surface electromyography and activity of oro facial muscles with the existing professional equipment in children with CP aged 3 to 6 year To compare the effect of the newly developed device and existing one on the the tone, strength,coordination and activity of oro facial muscles and oral motor functions of CP children |