| CTRI Number |
CTRI/2021/08/035501 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
15/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
to check the effectiveness of these 2 Dance movement and basic body awareness therapy treatment on autism child |
|
Scientific Title of Study
|
Body Awareness Therapy Versus Dance Movement Therapy In Children With Autism To Improve Body Awareness, Communication And Quality Of Movement. - A Comparative Study |
| Trial Acronym |
ARS 1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemang kumar jani |
| Designation |
Principal |
| Affiliation |
Saurashtra university |
| Address |
Harivandana physiotherapy college
saurshtra university campus Rajkot360005
Harivandana physiotherapy college
saurshtra university campus Rajkot360005
Rajkot
GUJARAT
360005
India |
| Phone |
9033762190 |
| Fax |
|
| Email |
hemangkumarjani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh M Solanki |
| Designation |
Physiotherapist |
| Affiliation |
Saurashtra university |
| Address |
Mangalmurti physiotherapy clinic
80 feet road
surendranagar
Rajkot
GUJARAT
363001
India |
| Phone |
8000940254 |
| Fax |
|
| Email |
rmsmyself6391@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemang kumar jani |
| Designation |
Principal |
| Affiliation |
Saurashtra university |
| Address |
Harivandana physiotherapy college
saurshtra university campus Rajkot360005
Harivandana physiotherapy college
saurshtra university campus Rajkot360005
Rajkot
GUJARAT
360005
India |
| Phone |
9033762190 |
| Fax |
|
| Email |
hemangkumarjani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jeevandeep health education trust kodinar gujarat |
| Sarva siksha abhiyana surendranagar gujarat |
| viklang trust and NGO Gujarat |
|
|
Primary Sponsor
|
| Name |
Maharshi Multispeciallity hospital |
| Address |
Near upasana circle, opp harikrishna restaurant Surendranagar |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aarifbhai |
Jeevandeep health education trust |
KOdinar
Junagadh
GUJARAT |
7984081010
rockysolankikgf1@gmail.com |
| Mahendrabhai |
Shree B D Barad Physitherapy college kodinar |
Ground floor, room no. 7,veraval bypass road, Kodinar
Junagadh
GUJARAT |
9624699231
ranusola6363@yahoo.com |
| Anandiben |
Shreeji viklang trust |
vanthli road, mendarada
Junagadh
GUJARAT |
9426146318
anandi1305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Safe Search Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F948||Other childhood disorders of social functioning, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Basic body awareness therapy |
Postural perturbation 10 rep,
Balance intervention 10 rep,
Diaphragmatic breathing 10 rep exercises,
Sensory motor processing for balance control 20 rep
Movement intervention 10 rep
communication intervention 5 min
5 min rest period between 2 exercise
Total period 1 hour session
|
| Intervention |
Dance movement therapy |
10 min warm up
20 min Dyadic Movement part
20 min Baum circle therapy
10 min verbal communication therapy
Protocol for 1 hour |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
• Autistic patients (patient’s diagnosis of CP confirmed by an expert pediatrician)
• Autism patients who are having problems affected of components in body awareness, communication and quality of movement.
|
|
| ExclusionCriteria |
| Details |
• Other than Autism patients
• Autism patients below 4year and above 18 year.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Childhood Autism rating scale |
•CARS-15 points for 15 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The Social Communication Questionnaire and body awareness rating scale |
scQ- 40 points within 40 min.
BARS- 12 points for 10 min |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not published still. continue process of research |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I am doing this trial to compare Basic boy awareness therapy and dance movement therapy in patients with autism to improve body awareness , communcation and quality of life in autism patients within 2 year of duration.
I am main investigator Dr. Rakesh Solanki who is doing this trial. and comparing this. I am physiotherapist an private practitioer |