| CTRI Number |
CTRI/2025/03/082789 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving Muscular Control and Everyday Activities in Children with Spastic Diplegic Cerebral Palsy Using a Tailored Exercise Program that is an Experimental Study |
|
Scientific Title of Study
|
Improving motor control and functional activity in spastic diplegic cerebral palsy through a customized exercise program-An Experimental Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sakshi tinker |
| Designation |
MPT |
| Affiliation |
SGT University |
| Address |
SGT Hospital Department Of Physiotherapy Gurgaon Haryana
SGT Hospital Department Of Physiotherapy Gurgaon Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8387868875 |
| Fax |
|
| Email |
sadhnatinker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr saurabh kumar |
| Designation |
Associate professor |
| Affiliation |
SGT University |
| Address |
SGT University Department Of Physiotherapy Gurgaon Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9023245955 |
| Fax |
|
| Email |
saurabh04pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vinika chaudhary |
| Designation |
Assistant professor |
| Affiliation |
SGT University |
| Address |
SGT University Department Of Physiotherapy Gurgaon Haryana India
Gurgaon
HARYANA
122505
India |
| Phone |
9650922399 |
| Fax |
|
| Email |
vinika.chaudhary90@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University Gurgaon Haryana India 122505 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Sakshi Tinker |
SGT Hospital |
Physiotherapy department of SGT Hospital Gurugram Haryana
Gurgaon
HARYANA |
8387868875
sadhnatinker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty 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 |
A customized exercise program |
6 weeks study
Group A or experimental group will receive a customized exercise program involving motor control for trunk, neuromotor integration training, and task oriented training. |
| Comparator Agent |
Traditional exercises |
6 week study Group B or control group received functional training, balance exercise, passive stretching for hip flexors, hip adductors, hamstrings and calf muscles followed by strengthening of weak muscles |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Study included children with spastic diplegic cerebral palsy with grade 1 to 2 spasticity who can walk with or without assistive devices and able to follow orders and verbal commands.
|
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with any other neurological condition or history of unstable seizures.
Patients with contracture in limbs.
Unwillingness to continue the exercise session.
Patient has received any special treatment related to my study in last 6 months.
Children with ventriculoperitoneal shunt or cardiac stimulator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle tone
Balance
Disability
Gross motor function |
On day 1 and at the end of 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/03/2025 |
| 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 sample of 40 subjects will be selected from the population on the basis of inclusion and exclusion criteria and equally divided into two groups. The experimental group received a customized exercise program which involve motor control training for trunk, neuromotor integration training for balance and task oriented training to improve functional activities in children with spastic diplegic cerebral palsy. And control group will receive the exercise which include function training, balance exercise, and passive stretching exercise for the hip flexors, hip adductors, hamstrings, and calf muscle followed by strengthening exercises for weak muscles. |