| 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
|
|
|
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
|
|
|
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. |
|
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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. |