| CTRI Number |
CTRI/2024/12/077855 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| 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
|
Effect of doing cognitive and motor task on balance and motor functions on cerebral palsy population |
|
Scientific Title of Study
|
Effect Of Dual Task Training vs Task Oriented Training On Balance and Gross Motor Functions Of Children With 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 |
Krutika Surana |
| Designation |
Post Graduate Student ( Masters of Physiotherapy Neurology) |
| Affiliation |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Physical Medicine And Rehabilitation Department of Neurorehabilitation, 2nd floor, sector C, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9322955898 |
| Fax |
|
| Email |
krutikasurana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Garima Wadhwa |
| Designation |
Assistant Professor |
| Affiliation |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Physical Medicine And Rehabilitation Department of Neurorehabilitation, 2nd floor, sector C, Vasant Kunj, New Delhi
South West
DELHI
110070
India |
| Phone |
9650086472 |
| Fax |
|
| Email |
garimawdhw@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Garima Wadhwa |
| Designation |
Assistant Professor |
| Affiliation |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences |
| Address |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Physical Medicine And Rehabilitation Department of Neurorehabilitation, 2nd floor, sector C, Vasant Kunj, New Delhi
DELHI
110070
India |
| Phone |
9650086472 |
| Fax |
|
| Email |
garimawdhw@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Centre Institute of Rehabilitation Sciences, Physical Medicine And Rehabilitation Department of Neurorehabilitation, 2nd floor, sector C, Vasant Kunj, New Delhi 110070, India |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injuries Centre Institute of Rehabilitation Sciences |
| Address |
Physical Medicine And Rehabilitation Department of Neurorehabilitation, 2nd floor, sector C, Vasant Kunj, New Delhi 110070, India |
| 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 |
| Aalam |
Akshya Pratishan |
Chruch Rd Shanti kunj B block Pocket 3 Sector D Vasant Kunj New Delhi -110070
South
DELHI |
9810112179
akshayprati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, Indian Spinal Injury Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G808||Other cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
Individual in this group will receive dual task training that is two task one motor and cognitive simultaneously. Exercises like sitting on swiss ball and cushion maintaining balance and performing activities like drawing, writing
Standing on balance cushion to maintain balance and perform activities like counting backwards, somple addition |
| Comparator Agent |
NA |
NA |
| Intervention |
Task oriented training |
Individual in this group will receive task oriented training that is one task will be repeated till it reaches its functional goal. Activities like Kicking ball rolled by therapist while stand by alternate right/left foot, Sitting on table and reaching an object in different directions, Stepping forward, backward and sideways on to blocks of various height, Squatting, Sit to stand from various height chair, Walking in parallel bar crossing various obstacles, Walking over various surfaces like cushion, Play around by throwing and rolling a gym ball will be performed repeatedly
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Child should be diagnosed with spastic cerebral palsy.Ability to follow verbal instructions.Age group between 6 to 12 years.Consent given by their parents.
Child with GMFCS level I and II.
Spasticity grade 1 and 1+ according to Modified Ashworth scale
|
|
| ExclusionCriteria |
| Details |
Child having any recent neurological or orthopedic surgery(including botnulim injections) in last 6 months
Diagnosed with visual or auditory problems that might interfere with the intervention.
Child with IQ below 70.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance |
Baseline and 4 weeks after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gross motor functions |
Baseline & 4 weeks after the intervention |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
26/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Cerebral palsy is a non-progressive disorder of brain insult affecting motor functions, cognition, learning, speech, and independence. Individuals with cerebral palsy often face muscle tone abnormalities, making it difficult to perform gross motor functions in daily activities. Dual-task training and task-oriented training are two approaches to improving motor performance in children with cerebral palsy. Recent research supports dual-task training as more beneficial than conventional therapy, while task-oriented training has improved balance, muscle strength, and motor skills. Comparing dual-task and task-oriented training can help understand how different intervention strategies affect balance and motor function, as traditional rehabilitation methods may not adequately address the complexities of daily living tasks. Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. (Group 1) will receive Dual task training with conventional physiotherapy treatment 5 times a week for 4 weeks. (Group 2) will receive task oriented training along with conventional physiotherapy for the same duration. Pre and post-intervention test will be carried out using- • Pediatric Balance Scale for balance. • Gross Motor Function Measure 88 for gross motor functions |