| CTRI Number |
CTRI/2026/02/103358 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| 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
|
IMPROVING BALANCE AND TRUNK STABILITY IN CHILDREN WITH SPASTIC CEREBRAL PALSY THROUGH TARGETED TRUNK EXERCISES |
|
Scientific Title of Study
|
EFFECTIVENESS OF TRUNK TARGETED TRAINING ON TRUNK CONTROL AND BALANCE IN CHILDREN WITH SPASTIC CEREBRAL PALSY |
| 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 KAMALLA SUPRATHEEKA |
| Designation |
Postgraduate Student |
| Affiliation |
Durgabai Deshmukh College Of Physiotherapy |
| Address |
Physiotherapy OutPatient Department Ground Floor Excercise Therapy Room DDH Campus Durgabai Deshmukh Hospital and Research Centre Vidya Nagar Adikmet Osmania University Road Hyderabad Telangana 500044
Hyderabad
TELANGANA
500044
India |
| Phone |
8179899538 |
| Fax |
|
| Email |
supratheekakamalla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M SWAPNA |
| Designation |
Associate Professor |
| Affiliation |
Durgabai Deshmukh College Of Physiotherapy |
| Address |
Physiotherapy OutPatient Department Ground Floor Excercise Therapy Room DDH Campus Durgabai Deshmukh Hospital and Research Centre Vidya Nagar Adikmet Osmania University Road Hyderabad Telangana 500044
Hyderabad
TELANGANA
500044
India |
| Phone |
9966182950 |
| Fax |
|
| Email |
bachuswapna1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M SWAPNA |
| Designation |
Associate Professor |
| Affiliation |
Durgabai Deshmukh College Of Physiotherapy |
| Address |
Physiotherapy OutPatient Department Ground Floor Excercise Therapy Room DDH Campus Durgabai Deshmukh Hospital and Research Centre Vidya Nagar Adikmet Osmania University Road Hyderabad Telangana 500044
Hyderabad
TELANGANA
500044
India |
| Phone |
9966182950 |
| Fax |
|
| Email |
bachuswapna1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy OutPatient Department Ground Floor Excercise Therapy Room DDH Campus Durgabai Deshmukh Hospital and Research Centre Vidya Nagar Adikmet Osmania University Road Hyderabad Telangana INDIA 500044 |
|
|
Primary Sponsor
|
| Name |
DR KAMALLA SUPRATHEEKA |
| Address |
Physiotherapy OutPatient Department Ground Floor Excercise Therapy Room DDH Campus Durgabai Deshmukh Hospital and Research Centre Vidya Nagar Adikmet Osmania University Road Hyderabad Telangana INDIA 500044 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KAMALLA SUPRATHEEKA |
Durgabai Deshmukh Hospital And Research Centre |
Physiotherapy OutPatient Department Ground Floor Excercise Therapy Room DDH Campus Vidya Nagar Adikmet Osmania University Road Hyderabad Telangana 500044
Hyderabad
TELANGANA |
8179899538
supratheekakamalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Durgabai Deshmukh Hospital And Research Centre |
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 |
CONVENTIONAL PHYSIOTHERAPY TREATMENT |
Conventional Physiotherapy Treatment Is Given
Week 1 Limb Approximation Upper And Lower Stretching And Reflex Inhibiting Patterns.
Week 2 Weight Shifting Training Affected Side And Upper Or Lower Limb Stretching And Strengthening.
Week 3 Floor Mat Transitions Moving Between Side Sitting And Quadruped Positions.
Week 4 Long Sitting With Dynamic Sideways Reaching.
Week 5 Stool Seated Reaching Sideways And Overhead And Standing Ball Toss Or Catch.
Week 6 Sitting To Forward Bend Picking Up A Ball Sitting To Throw And Intensive Gait Training. |
| Intervention |
TRUNK TARGETEG TRAINING |
Trunk Targeted Training Exercises Along With Conventional Physiotherapy Treatment.
Week 1 Anterior Posterior And Lateral Pelvic Tilts Trunk Flexion Extension And Rotation And Single Leg Stance With Support.
Week 2 Pelvic Bridging On A Stable Surface And Lower Trunk Rotations From A Crook Lying Position.
Week 3 Single Leg Standing Without Support Sitting And Reaching sideways And Overhead On A Stable Surface And Partial Squats With Support.
Week 4 Pelvic Bridging On An Unstable Surface And Sitting And Reaching Sideways And Overhead On A Swiss Ball.
Week 5 Unilateral Leg Raises While Bridging And Upper Trunk Rotations While Bridging With Hands Clasped.
Week 6 Modified Prone Bridge Exercise. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed Diagnosis of Spastic Cerebral Palsy By Pediatric Neurologist
Children With Level 1 2 And3 In Gross Motor Function Classification System GMFCS
Children With A Minimum Score Of Morethan Or Equal To 30 Out Of 58 Points In Trunk Control Measurement Scale
Children Who Are Able To Sit With Support According To Gross Motor Function Measure-88
Children Who Can Understand And Follow Instructions
|
|
| ExclusionCriteria |
| Details |
Children Who Are Uncooperative.
Any Orthopedic Surgery Or Spasticity Altering Procedures In The Previous 12 Months
Children Who Are Not Having The Minimum Score Of 30 Out Of 58 Points In Trunk Control Measurement Scale
Children With Associated Visual Auditory Or Perceptual Deficit
Children With Associated Cardiac Anomalies Affecting Exercise Tolerance |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TRUNK CONTROL
TCMS Trunk Control measurement Scale
GMFM-88 Gross Motor Function Measure-88 Sitting
|
Baseline Pre Intervention Assessment And After Six Weeks Of Treatment Post Intervention Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BALANCE
PBBS Pediatric Berg Balance Scale |
Baseline Pre Intervention Assessment And After Six Weeks Of Treatment Post Intervention Assessment |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
20/02/2026 |
| 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 - NO
|
|
Brief Summary
|
The purpose of this study is to evaluate whether the Trunk Targeted Training will improve Trunk Control and Balance in Spastic Cerebral Palsy Children compared to conventional physiotherapy Treatment .To study this A Randomized controlled trial will be conducted where children of age 6–14 years both male and females will be recruited and randomized into Intervention Group and Control Group .Each Group will have 23 Participants. The Data will be collected from both group at Baseline Pre-intervention Assessment and after six weeks Post-intervention Assessment.They were assessed for Trunk control using the Trunk Control Measurement Scale TCMS, Gross Motor Function Measure-88 GMFM-88, and for Balance using Pediatric Berg Balance Scale PBBS .After the Baseline Assessment Intervention Group will be given 50 minutes of therapy consisting of the 30 minutes of Conventional Physiotherapy Treatment along with 20 minutes of Trunk Targeted Training which includes pelvic tilts, bridging, and core stability on Swiss ball and Control Group will be given 30 minutes of Conventional Physiotherapy Treatment which includes stretching, weight shifting, and functional reaching both Groups will receive treatment for 5 days a week for 6 weeks. The Data will be statistically analyzed within and between the groups after Six weeks of Treatment and based on the Results obtained the benefit of addition of Trunk Targeted Training over the Conventional Physiotherapy Treatment in Treating Children with Spastic Cerebral Palsy can be Analyzed.
|