| CTRI Number |
CTRI/2025/08/092589 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness Of Intensive Interventions In Children With Cerebral Palsy |
|
Scientific Title of Study
|
Effectiveness of Combined Intensive Interventional Approach In Improving
Motor Functions In Children With Cerebral Palsy: A Prospective 3 Arm
Parallel Single Blinded Randomized Controlled Trial |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranavari Bhagya Sri Bai |
| Designation |
Ph.D. Scholar |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No.13 Paeditric physiotherapy, SDM College of medical sciences and hospital, Manjushree nagar, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7981794991 |
| Fax |
|
| Email |
ranavari03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranavari Bhagya Sri Bai |
| Designation |
Ph.D. Scholar |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No.13 Paeditric physiotherapy, SDM College of medical sciences and hospital, Manjushree nagar, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7981794991 |
| Fax |
|
| Email |
ranavari03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Parmar |
| Designation |
Professor and Principal |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No.13 Paeditric physiotherapy, SDM College of medical sciences and hospital, Manjushree nagar, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9845340450 |
| Fax |
|
| Email |
sanjaytparmar777@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Ranavari Bhagya Sri Bai |
| Address |
SDM College of Physiotherapy, Manjushree nagar, Sattur, Dharwad |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Dr Ranavari Bhagya Sri Bai |
OPD no.13, Paediatric Physiotherapy department, SDM College of Medical Sciences and Hospital |
SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad
Dharwad
KARNATAKA |
7981794991
ranavari03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College of Medical Sciences and Hospital |
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 |
| Comparator Agent |
Active Comparator |
All the intervention groups are active comparator to each other |
| Intervention |
Intervention 1 for Group A |
Upper extremity and trunk:
CIMT: Constraint induced moment therapy for Upper extremity of lasts for an average of 30 minutes
HABIT: Hand and Bimanual intensive training for bimanual activities last for an average of 30 minutes
CGR: Computer game based rehabilitation for affected arm lasts for 30 minutes
AOT: Action observation therapy lasts for 30 minutes
Trunk specific targeted protocol: based on the child needs trunk specific exercises will be given for 30-45 minutes
Progressive strength and flexibility training: Lasts for 60-90 minutes.
Along with a proper resting period among the interventions along with appropriate home exercise programme
|
| Intervention |
Intervention 2 for Group B |
Lower extremity and trunk:
Treadmill training with or without body-weight support lasts for 60 minutes
Functional Electrical Stimulation (FES) for targeted muscle activation lasts for an average of 60 minutes
Trunk specific targeted protocol: based on the child needs trunk specific exercises will be given for 30-45 minutes
Progressive strength and flexibility training: Lasts for 60-90 minutes.
Along with a proper resting period among the interventions along with appropriate home exercise programme
|
| Intervention |
Intervention 3 for Group C |
Upper extremity, Lower extremity and Trunk:
CIMT: Constraint induced moment therapy for Upper extremity of lasts for an average of 30 minutes
HABIT: Hand and Bimanual intensive training for bimanual activities last for an average of 30 minutes
CGR: Computer game based rehabilitation for affected arm lasts for 30 minutes
AOT: Action observation therapy lasts for 30 minutes
Treadmill training with or without body-weight support lasts for 60 minutes
Functional Electrical Stimulation (FES) for targeted muscle activation lasts for an average of 60 minutes
Trunk specific targeted protocol: based on the child needs trunk specific exercises will be given for 30-45 minutes
Progressive strength and flexibility training: Lasts for 60-90 minutes
Along with a proper resting period among the interventions along with appropriate home exercise programme
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age 4-10 years of either gender
2. Children with cerebral palsy confirmed by medical practitioner or paediatric neurologist
3. Children with GMFCS levels II-III with minimum 25-30 percentage of impairment in the outcomes like GMFM 66, QUEST, PDFM raw scores
4. Children with score of greater than 24 on Mini-Mental State Examination for Children (MMC) to understand and follow the commands of therapist.
5. Children and parents who gave consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Children with genetic disorders (Downs syndrome) and other diagnoses than CP
2. Children with severe complications like uncontrolled seizures
3. Children who underwent botulinum toxin,
surgeries in the last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Quality of Upper Extremity Skills Test (QUEST),
2. Fine motor dimension of Peabody Developmental Motor Scale (PDMS-2)(PDFM),
3. ABILHAND,
4. Computer games-assisted Upper Extremity (CUE) assessment tool,
5. Trunk Control Measurement Scale (TCMS),
6. Temporal variables of gait step length, stride length and velocity,
7. Selective Control
Assessment Of Lower Extremity (SCALE),
8. Physiological Cost Index,
9. Gross Motor Function
Measure-66 (GMFM-66),
10. Child engagement in daily life measure version 2,
11. Pediatric Quality of Life Inventory 4.0 Cerebral Palsy Module (PedsQL 4.0 Cerebral
Palsy Module). |
At baseline, 4th week and 8th week (0,4 & 8) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
19/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Children with early brain injuries are frequently referred to physiotherapy only after developmental delays become evident. Even the therapy provided is often infrequent and lacks intensity. The most common of these developmental delays include cerebral palsy (CP), defined as a non progressive disorder which is a result of injury to a developing brain. The dosage of interventions that includes duration, intensity and frequency are considered to be one of the important aspects of physiotherapy interventions as it is directly effects the outcomes of the child. Only a few studies have proven the effectiveness of combination of different interventions aiming at multiple aspects of the body at the same time such as intervening both Upper extremity (UE) and Trunk or Trunk and Lower extremity (LE) or all the aspects like UE, LE and Trunk, where the most important period of timeline of development will be lost, and the caregivers concerns and expectations should also be taken into consideration. There is a need to know the effectiveness of combination of most of the proven targeted exercises, providing equal importance and interventions for all aspects of the body as a unit rather working on anyone aspect. The current study aims to check the effectiveness of combination of intensive targeted physiotherapy interventions on the motor functions in children with cerebral palsy. |