| CTRI Number |
CTRI/2024/04/065926 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of fine motor activity during sitting in chair and therapy ball in autistic children |
|
Scientific Title of Study
|
Efficacy of Dynamic and Static sitting posture in improving fine motor skills in Autism Spectrum Disorder
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRISTI SHIKHA |
| Designation |
Research scholar |
| Affiliation |
Manav Rachna International Institute Research & Studies |
| Address |
QG07 Department of Physiotherapy School of Allied Health Sciences
Manav Rachna International Institute Research & Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India
Faridabad
HARYANA
121004
India |
| Phone |
9304857438 |
| Fax |
|
| Email |
shristishikha104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Aggarwal |
| Designation |
assistant professor |
| Affiliation |
manav rachna international institute of research and studies |
| Address |
QG07 Department of Physiotherapy School of Allied Health Sciences
Manav Rachna International Institute Research & Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India
Faridabad
HARYANA
121004
India |
| Phone |
9999597755 |
| Fax |
|
| Email |
divyaaggarwal.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Aggarwal |
| Designation |
assistant professor |
| Affiliation |
manav rachna international institute of research and studies |
| Address |
QG07 Department of Physiotherapy School of Allied Health Sciences
Manav Rachna International Institute Research & Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India
Faridabad
HARYANA
121004
India |
| Phone |
9999597755 |
| Fax |
|
| Email |
divyaaggarwal.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Q Block Department of Physiotherapy, SAHS, Manav Rachna International Institute of Research and Studies Sector – 43, Delhi–Surajkund Road Faridabad – 121004 Haryana, India |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [none] |
|
|
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 |
| SHRISTI SHIKHA |
Physiotherapy Department OPD & Neurology Lab |
Q Block Department of
Physiotherapy, MRIIRS,
Room No: QG 07, QG
08
Faridabad
HARYANA
Faridabad
HARYANA |
9304857438
shristishikha104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee at School of Allied Health Sciences, Manav Rachna International Institute of Research & Studies, Faridabad, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A- 15 subjects with ASD in chair sitting. |
Fine motor skill activity(4 weeks for 3 days a week).
Review every week and reassessment after 4 weeks. |
| Intervention |
GROUP B- 15 subjects with ASD on therapy ball sitting. |
Fine motor skill activity(4 weeks for 3 days a week).
Review every week and reassessment after 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Indian scale for assessment of autism
Children diagnosed with Autism Spectrum disorder
Higher function children with Autism
IQ level 60-75
|
|
| ExclusionCriteria |
| Details |
Upper limb musculoskeletal injuries
Visual impairment
Auditory impairments
Attention deficits
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 fine motor skills
2 Sensory profile |
pre interventional assessment and post interventional assessment will be taken of the outcome measures between the time period of 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sitting tolerance |
pre interventional assessment and post interventional assessment will be taken of the outcome measures between the time period of 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/04/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aim of
this study is to improve fine motor
skills in autism spectrum disorder in dynamic and static sitting posture. Patient will be recruited from physiotherapy out patient department of manav rachna university. A study of 30 participants will be selected on the basis of inclusion and exclusion criteria. The subjects will be randomly divided into 2 groups Group A 15 subjects with ASD in chair sitting Group B 15 subjects with ASD in therapy ball sitting both will be given fine motor skill activity. A written consent form will be given to the participants after explaining them the treatment protocol, associated risks and benefits. Outcome measures will be measured at baseline and after termination of 4 week will be compared. |