| CTRI Number |
CTRI/2025/07/090883 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Core stability exercises and Task oriented training to improve balance and gross motor function in hemiplegic cerebral palsy |
|
Scientific Title of Study
|
EFFICACY OF TASK ORIENTED TRAINING AND CORE STABILITY EXERCISES TO IMPROVE BALANCE AND GROSS MOTOR FUNCTION FOR LOWER LIMB IN HEMIPLEGIC CEREBRAL PALSY CHILDREN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G RAHUL RAM |
| Designation |
Student (Master of Physiotherapy) |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Fourth floor, Department of physiotherapy,395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Fourth floor, Department of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9500985002 |
| Fax |
|
| Email |
rahulg141298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Porkodi. R |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Fourth floor, Departmrnt of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Fourth floor, Departmrnt of physiotherapy,395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9500985002 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Porkodi.R |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Fourth floor, Department of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Fourth floor, Department of physiotherapy,395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9500985002 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Hospital, 395, Sarojini naidu road, Sidhapudhur,Coimbatore 641044, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
GRAHULRAM |
| Address |
Department of neurology physiotherapy ,SRIPMS
395,sarojni naidu rd, siddhapudur,new siddhapudur, coimbatore,tamilnadu
Coimbatore
TAMIL NADU
1
India
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| GRAHUL RAM |
Sri Ramakrishna Multispeciality Hospital |
Fourth floor, Department of physiotherapy, 395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
395, Sarojini Naidu Road, Siddhapudur, Coimbatore - 641044
Coimbatore
TAMIL NADU |
9500985002
rahulg141298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hosptal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G802||Spastic hemiplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CORE STABILITY EXERCISES |
Core stability Exercises |
| Intervention |
TASK ORIENTED TRAINING |
Group A Task oriented training
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Hemiplegic cerebral palsy children Unilateral Right or Left
Age group between 6 to 12 years
Both male and female
Modified Ashworth scale MAS in lower limbs 1 and 2
Gross Motor Function Classification System GMFCS level I and II
The children who are able to follow instructions during evaluation and treatment procedures |
|
| ExclusionCriteria |
| Details |
Received botulinum toxin in the lower extremity musculature during the past 6 months
Visual and auditory or perceptual deficits
Uncontrollable seizures or epilepsy
Having hip and knee flexion contracture
Children with equinus and jumping gait
Fractures of upper and lower limbs Any recent surgical interference for the lower limb
Vertigo or dizziness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gross Motor Function Measure
|
Baseline
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Paediatric Berg Balance Scale |
Baseline
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/07/2025 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
This study focuses on improving balance and gross motor function especially in the lower limbs in children with hemiplegic cerebral palsy It compares the effectiveness of task-oriented training which involves practicing real-life activities and core stability exercises which strengthen the muscles around the trunk and pelvis The goal is to help these children improve their ability to move walk and perform daily activities more independently and safely |