| CTRI Number |
CTRI/2024/11/076116 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Link between movement imagination and body movement function in Children with Cerebral Palsy aged 7-16 years |
|
Scientific Title of Study
|
Correlation between Motor Imagery and Gross Motor Function in Children with Cerebral Palsy aged 7-16 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanisha Goyal |
| 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-560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
7888233008 |
| Fax |
|
| Email |
tanisha.mhsblr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No. 98, Rustam Bagh, Old Airport Road, Bangalore
Karnataka-560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement, Department of Physiotherapy, Manipal Hospital, No. 98, Rustam Bagh, Old Airport Road, Bangalore
Karnataka-560017
India
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL Old Airport Road, Bangalore,
Karnataka-560017
India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL Old Airport Road, Bangalore,
Karnataka-560017
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 |
| Dr Santosh Kumari |
Association of People with Disability |
room 8, 6th cross road, Horamavu Agara Road, off, Hutchins RD, St Thomas Town, Lingrajpuram, Bengaluru
Karnataka-560084
India
Bangalore
KARNATAKA |
9591351441
santhoshkumaris@apd-india.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal hospital,Bangalore |
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 |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
GMFCS I, II, III
Children who can understand and follow commands |
|
| ExclusionCriteria |
| Details |
Children whose parents don;t provide consent
Children who are unwilling to participate
Children undergone any surgical procedure in the last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gross Motor Function
Motor Imagery |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
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)
|
15/11/2024 |
| 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 Yet Recruiting |
| 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
|
Children with CP suffer majorly with motor impairments. Gross motor functions are affected through a greater percentage among the many motor difficulties. Motor Imagery is a process of simulation of motor actions without actually giving a motor output. Motor Imagery plays a vital role in motor function by facilitating motor planning and execution. Children with cerebral palsy have been treated using concepts of motor imagery to improve functional ability, gross motor function, grasping actions. Use of motor imagery as a physical therapy intervention has shown to have benefits in these individuals. |