| CTRI Number |
CTRI/2025/02/080859 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Enhancing Speech and Reducing Drooling in Children with Cerebral Palsy: The impact of PNF and Oromotor Rehabilitation. |
|
Scientific Title of Study
|
Effect of Proprioceptive Neuromuscular Facilitation (PNF) with Oromotor Rehabilitation on Drooling Severity, Frequency and Speech Efficiency among Cerebral Palsy Children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joram Yami |
| Designation |
PG Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301 Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
6003131820 |
| Fax |
|
| Email |
joram.yami@s.amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Jain |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301 Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchika Kalra |
| Designation |
Teaching Associate |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301 Gautam Buddha Nagar
UTTAR PRADESH
201301
India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9718417185 |
| Fax |
|
| Email |
rkalra1@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301 Gautam Buddha Nagar UTTAR PRADESH 201301 India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
|
|
Primary Sponsor
|
| Name |
Joram Yami |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences, Amity University Sector 125 Noida 201301 Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Joram Yami |
Reborn Physiotherapy And Neuro Rehabilitation clinic |
Plot No. 649, Ground Floor, Shakti Khand-4, Near Kailash Mansarovar Bhawan, Indirapuram, Ghaziabad
201014
Ghaziabad
UTTAR PRADESH |
6003131820
joram.yami@s.amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar pardesh |
Approved |
| Reborn Physiotherapy and Neuro Rehab Clinic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oromotor rehabilitation |
It is also known as oral motor therapy(OMT) is a treatment that uses exercises to improve the strength, coordination and control of muscles in the mouth and face.
Exercises should be performed at least 2- 3 times a day for 5-10 mins depending upon the severity |
| Comparator Agent |
Proprioceptive Neuromuscular Facilitation (PNF) |
PNF approaches are used in treatment to enhance bodily processes or activities. They aim to facilitate, inhibit, strengthen and relax muscle groups to achieve a specific goal for functional mobility.
Starting with passive motion and progressing to actively resisted movement.
Stretching sessions typically last 15-30 minutes, depending upon individual goals and needs. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of cerebral palsy with drooling
Confirmed diagnosis of neuromuscular disorders
Informed consent obtained by their parents/caregivers
|
|
| ExclusionCriteria |
| Details |
Confirmed diagnosis of congenital problems as cleft lip and palate
Previous surgical interventions for saliva control
Involvement in other medical studies
Parents declined to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oromotor Skills
|
Baseline assessment- before intervention
Follow up assessment- after intervention 2 week, 4 week, 6 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proprioceptive Neuromuscular Facilitation(PNF) |
Baseline assessment- before intervention
Follow up assessment- after intervention 2 week, 4 week, 6 week |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 3 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="3"
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
|
To know the effect the of Proprioceptive Neuromuscular Facilitation(PNF) with Oromotor Rehabilitation in controlling drooling and speech. |