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CTRI Number  CTRI/2024/07/071426 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
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   a toy-based spirometer helping children with pneumonia. and its effect on chest expansion, breathlessness, cough, sputum, and measuring physical activity enjoyment  
Scientific Title of Study   Effectiveness of Toy based Spirometer on Chest expansion, Breathlessness, Cough and sputum Along with Physical activity Enjoyment in Pediatric Pneumonia Patients: 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  Dr.Chitra . P. Jha 
Designation  Post graduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Dept. of Cardio-respiratory Physiotherapy, OPD-4, MGM Institute of
Physiotherapy
Aurangabad
MAHARASHTRA
431003
India 
Phone  7039535672  
Fax    
Email  chitrajha22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Vaibhav Kapre 
Designation  Associate Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Dept of Cardio-respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy. Aurangabad MAHARASHTRA 431003 India

Aurangabad
MAHARASHTRA
431003
India 
Phone  9425346903  
Fax    
Email  vaibhavkapre@mgmiop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr.Chitra . P. Jha 
Designation  Post graduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Dept. of Cardio-respiratory Physiotherapy, OPD-4, MGM Institute of
Physiotherapy
Aurangabad
MAHARASHTRA
431003
India 
Phone  7039535672  
Fax    
Email  chitrajha22@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy N6-Cidco Aurangabad Maharashtra 431003 India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  N6-Cidco, Aurangabad Maharashtra 431003 India 
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 Chitra Jha  MGM medical Hospital  Cardiovascular respiratory Physiotherapy Department Medical Hospital, N-6 Cidco Aurangabad Maharashtra Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA 		 07039535672

chitrajha22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional physiotherapy  percussion, vibration, huffing, and coughing will be performed daily on patient  
Intervention  Toy-based spirometers in patients with pnuemonia   The Patient take a deep breath, blows into the mouthpiece, and holds the breath for 2–6 s. while this procedure secreation will be removed by huffing and coughing and should be repeated 10–12 times, twice a day. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Age group of 4–10 years

2. Both male and Female

3.Pneumonia children’s irrespective of Condition with different types of pneumonia
 
 
ExclusionCriteria 
Details  Congenital chest deformity.
Recent History (6 months) of pneumothorax or
Thoracic/Abdominal surgeries.
Pleural effusion with or without intercostal drain
Marked Respiratory Distress or hypoxia (oxygen saturation)
90 percent on oxygen support. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Measurement of Chest Expansion   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Breathlessness, cough and sputum scale (BCSS)
2. Physical Activity enjoyment scale (PACE)
 		 20 minutes 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   20/09/2024 
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="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-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 [chitrajha22@gmail.com].

  6. For how long will this data be available start date provided 10-12-2024 and end date provided 10-12-2028?
    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 - no
Brief Summary   Patients diagnosed with pneumonia of any age group between 4 and 10 years old will be taken. The participants that meet the inclusion criteria will be chosen for the study. Written and oral consent from the participants will be obtained, and all procedures will be explained. Demographic data and assessment data will be taken. Baseline data will be taken. Patients are randomly allocated and divided into two groups (Group A and Group B).  The Group A -experimental group and the Group B- control group, both groups will be given the intervention. The experiment group will give a conventional physiotherapy treatment along with measurements of chest expansion. The control group patients will receive routine physiotherapy, which includes positioning, deep breathing exercises (3-5 reps with a 10-second hold), Percussion and Vibration (As per required), Huffing and coughing, and coughing (After each session, 3-5 reps) Segmental expansion exercises: this session is given for around 15 to 20 minutes daily until the patient is admitted to the hospital. If the patient feels any type of discomfort, treatment should be stopped. And before the discharge of the patient, all outcomes will be checked to assess the progression of all the parameters. 
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