| CTRI Number |
CTRI/2024/11/076482 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Video Game-Based Training on Balance and Coordination in Autism Children. |
|
Scientific Title of Study
|
Exploring the impact of video game based training on Balance and Coordination in children with Autism spectrum disorder: A randomized controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Baldha Radhika Gopalbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9723266746 |
| Fax |
|
| Email |
rbaldha974@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Solanki |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9714054600 |
| Fax |
|
| Email |
chirag.solanki@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Baldha Radhika Gopalbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Research Department, Room no.207, School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India.
Rajkot
GUJARAT
360020
India |
| Phone |
9723266746 |
| Fax |
|
| Email |
rbaldha974@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, Rajkot, Gujarat, India. 360020 |
|
|
Primary Sponsor
|
| Name |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
360020 |
| 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 |
| Baldha Radhika Gopalbhai |
School of Physiotherapy, RK University |
Research department,Room no. 7, School of Physiotherapy, RK University, Kasturbadham,
Rajkot-Bhavnagar Highway, Rajkot, Gujarat, India
360020
Rajkot
GUJARAT |
9723266746
rbaldha974@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, School of Physiotherapy, RK University |
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 |
| Comparator Agent |
Conservative treatment Protocol |
Control Group will be taken Conservative Physiotherapy Treatment for Balance and Coordination. 5 days per week for 3 weeks. Take post intervention Outcome. |
| Intervention |
Video game based training
|
Explanation of the study to the patient’s parents.
After taking the consent form,
Baseline assessment of the patient will be taken through Specialized sensbalance miniboard. Intervention Group in which Video game based Balance and Coordination training Will be given. 5 days per week for 3 weeks. Take post intervention Outcome.
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis by qualified Pediatric Neurologist or Neurophysician,
Both boys and girls,
Age group 5-12 year,
Minimum 45 Score in Pediatric Balance test |
|
| ExclusionCriteria |
| Details |
Presence of severe medical conditions or neurological disorders other than ASD.
Non-cooperation from the child or guardian
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static Balance
Dynamic Balance
|
At Baseline and after 3 week Intervention
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2024 |
| 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 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
|
Introduction: Children with Autism Spectrum Disorder (ASD) often face challenges with balance and coordination, affecting their motor development. Traditional therapies may not always be engaging or effective. Video game-based training, with its interactive nature, has emerged as a promising alternative to improve these motor skills in children with ASD. This approach provides real-time feedback and can adjust to the child’s skill level, potentially enhancing motivation and therapy outcomes. Aim and Objectives: - Aim: To assess the effectiveness of video game-based training in improving balance and coordination in children with ASD.
- Objectives: A randomized controlled trial will compare video game-based training to traditional therapy. Intergroup and intragroup differences in balance and coordination will be measured, and the impact will be evaluated using specialized tools.
Materials and Methods: - Materials: Consent forms, assessment forms, a laptop with Sensamove software, and specialized Sensbalance Miniboard.
- Study Design: Randomized controlled trial with 60 children with ASD, divided into two groups (Group A - video game-based training, Group B - traditional therapy).
- Duration: 6 months.
- Setting: School of Physiotherapy, RK University, and local pediatric physiotherapy centers.
- Outcome Measures: Static and dynamic balance and coordination using the Sensbalance Miniboard.
|