| CTRI Number |
CTRI/2024/11/076812 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Brain Gym Exercises on sensory behavior in children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Effect of Brain Gym Exercises on sensory behavior 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 |
Pratibha |
| Designation |
Postgraduate student (Master in occupational therapy Neurology) |
| Affiliation |
Indian spinal injuries center, institute of rehabilitation sciences |
| Address |
Indian spinal injuries center, institute of rehabilitation sciences, Rehabilitation Department 2nd floor, sector C, Vasant Kunj, South Delhi- 110070 New Delhi 110070 India
South
DELHI
110070
India |
| Phone |
8745872125 |
| Fax |
|
| Email |
pratibha.kharayat30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ashish Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Indian spinal injuries center, institute of rehabilitation sciences |
| Address |
Indian spinal injuries center, institute of rehabilitation sciences, Rehabilitation Department 2nd floor, sector C, Vasant Kunj, South Delhi- 110070 New Delhi 110070 India
South
DELHI
110070
India |
| Phone |
8851194635 |
| Fax |
|
| Email |
ashishjha2712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish Kumar Jha |
| Designation |
Assistant Professor |
| Affiliation |
Indian spinal injuries center, institute of rehabilitation sciences |
| Address |
Indian spinal injuries center, institute of rehabilitation sciences, Rehabilitation Department 2nd floor, sector C, Vasant Kunj, South Delhi- 110070 New Delhi 110070 India
South
DELHI
110070
India |
| Phone |
8851194635 |
| Fax |
|
| Email |
ashishjha2712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Spinal Injuries Center Institute of rehabilitation sciences |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Pratibha |
Indian Spinal Injuries Center |
Institute of Rehabilitation Sciences, Rehabilitation Department 2nd Floor, Sector C, Vasant Kunj south Delhi- 110070, delhi
South
DELHI |
8745872125
pratibha.kharayat30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indian Spinal Injuries Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercises |
Out of 26 brain gym exercises only 4 exercises will be given to children by randomization for 20 mins and sensory integration therapy for 30 mins and it will be given for 3 sessions over a course of 8 weeks |
| Comparator Agent |
Sensory integration therapy |
It includes these activities Swings, scooters, jump ropes
Varying flavors of food and beverages
Massage balls, tactile balance platform
Resistance bags , punching bags
Sounds of different types & intensities for 30 mins and for 20 mins fine motor activities will be given for 3 sessions over a course of 8 weeks
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. able to follow simple verbal commands.
2. children with mild autism (according to ISSA scale i.e, 70-106) |
|
| ExclusionCriteria |
| Details |
1. children with epilepsy/seizures.
2. known case of any cardiorespiratory problems.
3. children diagnosed with neurological conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short Sensory Profile |
baseline and after 8 weeks of intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
25/11/2024 |
| 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="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
|
Sensory abnormalities are a very frequent feature that often go unnoticed due to the communication difficulties of these patients. The impact of sensory abnormalities of children with ASD on their daily lives is considerable. Sensory functioning is an area of concern for individuals with autism spectrum disorders. These sensory differences may manifest themselves in unusual, rigid, and routinized behaviors, and contribute to difficulties in social communication. Brain gym is an intervention planned to improve various outcomes along with attention, memory and academic skills by stimulating both hemispheres of brain through neurological re-patterning to boost whole brain learning. There are many studies which have investigated an effect of brain gym exercises on many areas such as intelligence, knowledge, balance, postural instability in autism, Down’s syndrome, and many other developmental disability and authors found it very useful in all these areas. The available literature regarding the effect of brain gym exercises has been explored knowledge skills, intelligence, and motor performance in autism spectrum disorder but to the best of my knowledge study related to addressing effect of brain gym exercises on sensory behavior is yet to be explored. children will be screened based on inclusion and exclusion criteria and then they will be enrolled into 2 groups with the help of random allocation software. (Group1) will receive brain gym exercises with conventional therapy and (Group 2) will receive conventional therapy for 3 sessions in course of 8 weeks. The outcome measurement will be done by using Short Sensory Profile. variations in pre and post outcome measure will help us to find out effect of brain gym exercises on sensory behavior in autism. |