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CTRI Number  CTRI/2024/04/065102 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Controlled trial on effect of TAKO Protocol on infants with Pneumonia having respiratory and oromotor complications. 
Scientific Title of Study   Effect of Multimodal Integrated Rehabilitation using TAKO Protocol on Oro-motor and Respiratory Complications in Infants with Pneumonia: A Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Desai  
Designation  PG Student 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU),Wardha 
Address  Room no.1,1st floor,Department Of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU)

Wardha
MAHARASHTRA
442001
India 
Phone  9967494549  
Fax    
Email  desaisakshi10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Neha Umale 
Designation  Assossciate Professor  
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU),Wardha 
Address  Room no.2,1st floor,Department Of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU)

Wardha
MAHARASHTRA
442001
India 
Phone  9665682103  
Fax    
Email  umale.neha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sakshi Desai  
Designation  PG Student 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU),Wardha 
Address  Room no.1,1st floor,Department Of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU)

Wardha
MAHARASHTRA
442001
India 
Phone  9967494549  
Fax    
Email  desaisakshi10@gmail.com  
 
Source of Monetary or Material Support  
Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU), Wardha 442001 
 
Primary Sponsor  
Name  Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research 
Address  Ravi Nair Physiotherapy College, Datta Meghe Institute Of Higher Education and Research(DU), Wardha 442001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharath Hullumani V  Acharya Vinoba Bhave Rural Hospital   Room no 19, 2nd floor, Department of Pediatric, Acharya Vinoba Bhave Rural Hospital, Sawangi(Meghe), Wardha-442001
Wardha
MAHARASHTRA 		 996406697

sharathhullumani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research (DU) Institutional Ethical Committe   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J188||Other pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Chest physiotherapy daily for 4 weeks  
Intervention  TAKO Protocol  Tactile stimulations, Airway Clearance Technique, Kinesthetic stimulations, Oro-motor stimulations daily for 4 weeks  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  6.00 Month(s)
Gender  Both 
Details  1. Infants aged between 1 day to 6 months
2. Clinical diagnosis of pneumonia based on established criteria.
3. Infants admitted to the neonatal intensive care unit (NICU) or Paediatric Intensive Care Unit (PICU) or Paediatric ward
4. Written informed consent obtained from parents or legal guardians  
 
ExclusionCriteria 
Details  Gestational age less than 37 weeks
2. Major congenital anomalies affecting oromotor or respiratory function.
3. Severe neurological impairment or congenital disorders affecting swallowing or breathing
4. Participation in concurrent interventions targeting oromotor or respiratory function. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
ABG Analysis
Oromotor Assessment Scale (OMAS)
 		 Baseline, 2nd week and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Infant Neurological International Battery (INFANIB)  Baseline, 2nd week and 4th 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   N/A 
Date of First Enrollment (India)   10/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharathhullumani@gmail.com].

  6. For how long will this data be available start date provided 18-03-2024 and end date provided 18-03-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The primary aim of the study is to investigate the impact of the TAKO protocol, a multimodal rehabilitation approach, on oro-motor and respiratory complications in infants with pneumonia. The study is crucial as it address a significant gap in the understanding of rehabilitation strategies for onfants with pneumonia, particularly focusing on oromotor  and respiratory complications. Infants are vulnerable to these complications and the TAKO protocol represents a novel approach that integrates multiple rehabilitation modalities. By conducting a randomized control trial, the research aims to provide robust evidence on the effectiveness of this protocol, contributing valuable insights to infants care practices. 
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