| CTRI Number |
CTRI/2024/12/077906 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Home Environment effect on Motor Development in Children with Special Needs |
|
Scientific Title of Study
|
Effect of Home Environment on Motor Development in Children with Special Needs: A cross sectional 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 |
Dr Vinuta Deshpande |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy , Belagavi |
| Address |
Advanced physiotherapy center, department of paediatric physiotherapy room no 39, sagar floor, KLE DR Prabhakar Kore Hospital & MRC , nehru nagar Belagavi, Karnataka 590010, India
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy , Belagavi |
| Address |
Advanced physiotherapy center, department of paediatric physiotherapy room no 39, sagar floor, KLE DR Prabhakar Kore Hospital & MRC , nehru nagar Belagavi, Karnataka 590010, India
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute of Physiotherapy , Belagavi |
| Address |
Advanced physiotherapy center, department of paediatric physiotherapy room no 39, sagar floor, KLE DR Prabhakar Kore Hospital & MRC , nehru nagar Belagavi, Karnataka 590010, India
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Research center, Nehru Nagar , Belagavi, Karanataka, India - 590010 |
|
|
Primary Sponsor
|
| Name |
KAHER Institue of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy , JNMC campus, Nehru Nagar , Belagavi, Karnataka, India-590010 |
| 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 Vinuta Deshpande |
KAHER Institute of Physiotherapy |
Advanced physiotherapy center, room no 39 sagar floor KLE Dr Prabhakar Kore Hospital & MRC , Nehru Nagar, Belagavi, Karnataka, India -590010
Belgaum
KARNATAKA |
8754466612
vinuta.gangavatikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee KAHER Institute of Physiotherapy |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children with special needs aged 5 months to 14 years,
both genders,
parents of the subject willing to participate
Children diagnosed with disabilities (eg: cerebral palsy, autism spectrum disorder, locomotor disability,intellectual disability) |
|
| ExclusionCriteria |
| Details |
Children with bedridden conditions
Children on ventilators or oxygen support
Children admitted to the hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Home Observation Measurement of the Environment- short form (HOME-SF)
Gross Motor Function Measure -88 (GMFM-88) |
BASELINE- T0 at the time of pre-assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/12/2024 |
| 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="0"
Months="6"
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
|
To determine the Effect of Home Environment on Motor Development in Children with Special Needs, 80 children with special needs will be recruited for the study, Parents will be contacted through special schools and by the hospital OPD, and HOME-SF will be used to evaluate home environment and GMFM-88 will be used to evaluate the motor development. Data will be collected and then analyzed. |