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CTRI Number  CTRI/2024/05/067155 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 09/03/2025
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   Involvement of parents along with physiotherapist for the treatment of children with cerebral palsy  
Scientific Title of Study   Effectiveness of Parent Integrated Physiotherapeutic Approach (PIPTA) on gross motor function and balance in children with spastic diplegia: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  Hiba Mariyam Azeem 
Designation  Post graduate student 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department no.20 Physiotherapy Department,Justice K.S Hegde Charitable Hospital,Medical Science Complex,University Road,Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8891634013  
Fax    
Email  hibazy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakesh Krishna Kovela 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department no.20 Physiotherapy Department,Justice K.S Hegde Charitable Hospital,Medical Science Complex,University Road,Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  rakesh.krishna@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Rakesh Krishna Kovela 
Designation  Associate Professor 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department no.20 Physiotherapy Department,Justice K.S Hegde Charitable Hospital,Medical Science Complex,University Road,Deralakatte, Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  rakesh.krishna@nitte.edu.in  
 
Source of Monetary or Material Support  
Department no.20 Physiotherapy Department,Justice K.S Hegde Charitable Hospital,Medical Science Complex,University Road,Deralakatte, Mangaluru 575018 
 
Primary Sponsor  
Name  NITTE Institute of Physiotherapy(NITTE Deemed to be University) 
Address  Department no.20 Physiotherapy Department,Justice K.S Hegde Charitable Hospital,Medical Science Complex,University Road,Deralakatte, Mangaluru 575018 
Type of Sponsor  Other [Constituent Physiotherapy Institute of NITTE Deemed to be University] 
 
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 
Hiba Mariyam Azeem  Justice K.S Hegde Charitable Hospital  Department of physiotherapy, Room number 20, second base division, Justice K S Hegde Charitable Hospital, Medical Science Complex, University Road, Deralakatte, Mangaluru 575018
Dakshina Kannada
KARNATAKA 
8891634013

hibazy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Nitte Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PARENT INTEGRATED PHYSIO THERAPEUTIC APPROACH (PIPTA) AND STANDARD CARE  The gross motor function measurement 88 and the paediatric balance scale will be used for the pre-intervention assessment. The intervention group will receive PIPTA intervention (extremity stretches and trunk control activities)  and standard care (stretching, range-of-motion exercises, positioning, and balance board activities) for thirty minutes each, five times a week (twice by the therapist and three times by the parents) for a duration of four weeks 
Comparator Agent  STANDARD CARE  The gross motor function measurement 88 and the paediatric balance scale will be used for the pre-intervention assessment.  The control group will receive standard care from a therapist for thirty minutes, five times a week for four weeks. It consists of exercises involving stretching, range of motion activities, positioning, and balancing boards activities  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children diagnosed with Spastic Diplegia.
2. Children with either gender or age ranging from 5 to 12 years.
3. Children with GMFCS level I II and III.
4. Children who can follow verbal command with MMSE score above 30. 
 
ExclusionCriteria 
Details  1. Children with history of recurrent seizures.
2. Children who are under medications such as anti-epileptic and anti hypertensive drugs.
3. Children who underwent recent spinal or pelvic surgery
4. Children who have fixed spinal and ankle deformities.
5. Children who have cardiac anomalies. 
 
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 
Gross motor function measurement 88 (GMFM 88)
Paediatric balance scale (PBS) 
Pre intervention (1st day) and post intervention (4th week)
Intervention period is 4 weeks followed by follow up after 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Depression, anxiety, stress scale 21 (DASS 21)-kannada version  Pre intervention (1st day) & post intervention (4th week)
Intervention period is 4 weeks 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/06/2024 
Date of Study Completion (India) 01/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Studies show that Parent-delivered therapy helps children achieve better motor outcomes. Interventions given in home environment enhances motivation and engagement, and balances the effectiveness and compliance of children and care givers. Implementing task-oriented programmes at home produced improvement in performance with functional balance and the improvement persisted even after the training is completed.

Studies also suggest that with improvements in self-care and mobility of a CP child, there is reduction in physical strain of caring in caregivers. Being actively involved  in their child’s therapy reduces the emotional strain of caregivers.

Parent coaching is the key element of such interventions. In order to properly execute the intervention and understand its goal, parents and medical professionals must receive the necessary training and instruction. Applying a successful parent-delivered intervention requires reciprocal trusting relationships between the child, caregiver, and health care provider. By increasing connection and bonding time, a well-delivered parent-delivered intervention can improve the parent-child relationship which in turn develops the motor improvements in the child. Though parent delivered therapy improves the motor outcome of child, it can’t replace the expert health care professional care .There is scarce of evidence supporting an integrated strategy in which a therapist treats the child and involves parents in the treatment plan. There is also a lack of evidences for detailed description of working mechanism of an intervention that involves parents.  Also, there are fewer evidence that home therapy improved gross motor functions and balance outcomes. Therefore, the study intends to evaluate the effectiveness of `Parent Integrated Physio Therapeutic Approach’(PIPTA) on motor functions and balance on Children with Spastic Diplegia .This approach will include professional treatment, parent delivered home based program and parent education for environmental enrichment of the child to improve his functions.

 
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