| CTRI Number |
CTRI/2026/03/106629 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“How Mind–body training Helps Improve Balance and Thinking Skills in Children with Cerebral Palsy” |
|
Scientific Title of Study
|
Effect of Psychomotor Rehabilitation
on balance and cognition in children with cerebral palsy: A Randomized
Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revati Surve |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement department of physiotherapy Manipal hospital no 98 Rustam Bagh old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
7083930759 |
| Fax |
|
| Email |
revati.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArunima Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement department of physiotherapy Manipal hospital no 98 Rustam Bagh old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9987194977 |
| Fax |
|
| Email |
arunima.biswas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrArunima Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement department of physiotherapy Manipal hospital no 98 Rustam Bagh old airport road Bangalore Karnataka
Bangalore
KARNATAKA
560017
India |
| Phone |
9987194977 |
| Fax |
|
| Email |
arunima.biswas@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy Manipal college of health professionals Manipal academy of higher education no 98 old airport road Bangalore Karnataka 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher education |
| Address |
Department of physiotherapy Manipal college of health professionals Manipal academy of higher education no 98 old airport road Bangalore Karnataka 560017 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Revati Surve |
Association of people with disability |
6th cross road horamavu agara road off hutchins rd st thomas town lingarajapuram banglore karnataka 560084
Bangalore
KARNATAKA |
7083930759
revati.mhsblr2024@learner.manipal.edu |
| Revati Surve |
Spastic society of karnataka |
8th main road Indiranagar 1st stage Bangalore Karnataka 560038
Bangalore
KARNATAKA |
7083930759
revati.mhsblr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Manipal Hospitals Bangalore |
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 |
Tandem standing
Standing heel raises
Single leg reaches
Balancing on a Bosu ball
Walking on uneven surfaces
Memory cue exercises
Repeating numbers
Matching numbers or shapes
Task switching and changing commands |
| Intervention |
Psychomotor Rehabilitation |
Psychomotor rehabilitation is a therapy that combines motor and cognitive training to improve functional abilities in children with Cerebral Palsy.It enhances coordination, balance, posture, motor skills, and cognitive development by integrating sensory, cognitive, and motor functions.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Children Diagnosed with cerebral palsy.
2. All Types of spastic diplegic CP
3. Children under GMFCS Level 1,2 and 3.
4. age group 4 to 17 both male and female.
5. cognitive impairment. WHO ICD 11 for ID. |
|
| ExclusionCriteria |
| Details |
1.Exercise induced reflex seizures.
2.Recent Surgical Intervention ( 6 month depend upon severity of surgery)
3.Sever visual and auditory Impairment. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pediatric Balance Scale
Posture and posture ability scale |
Pre-post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Communication function classification scale
Pediatric mmse |
pre-post |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
30/03/2026 |
| 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) |
Open to Recruitment |
|
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
|
Psychomotor rehabilitation is a therapeutic approach that integrates motor, cognitive, and sensory training to improve functional abilities in children with Cerebral Palsy. By targeting both motor deficits and cognitive impairments together, it helps improve balance, coordination, posture, cognitive development, daily activities, and social participation, leading to better overall quality of life. |