| CTRI Number |
CTRI/2025/06/088195 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Interactive gaming and voice commands on childrens attention and coordination in the age group of 5 to 7 years |
|
Scientific Title of Study
|
Effect of Interactive Games with Voice Assistant-Activated Commands on Attention Coordination and Hand-eye Coordination in Children aged 5 to 7 years. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanya Kundra |
| Designation |
PG Student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Delhi Pharmaceutical Sciences and Research University Sector 3 Pushp Vihar New Delhi 110017
South
DELHI
110017
India |
| Phone |
7838024311 |
| Fax |
|
| Email |
sanyakundra5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sapna Dhiman (PT) |
| Designation |
Assistant Professor |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room No 602 6th Floor School of Physiotherapy DPSRU
South
DELHI
110017
India |
| Phone |
8588055147 |
| Fax |
|
| Email |
sapnaphysio@dpsru.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanya Kundra |
| Designation |
PG Student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Delhi Pharmaceutical Sciences and Research University Sector 3 Pushp Vihar New Delhi 110017
South
DELHI
110017
India |
| Phone |
7838024311 |
| Fax |
|
| Email |
sanyakundra5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Delhi Pharmaceutical Sciences and Research University Sector 3 Pushp vihar New Delhi 110017 |
|
|
Primary Sponsor
|
| Name |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Delhi Pharmaceutical Sciences and Research University Sector 3 New DElhi 110017 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| SANYA KUNDRA |
Pediatric OPD |
Ground floor School of Physiotherapy Delhi Pharmaceutical Sciences and Research University Sector 3 Pushp Vihar New Delhi 110017
South
DELHI |
07838024311
sanyakundra5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITEE, DPSRU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interactive games with Voice assistant-activated Commands |
GROUP A- Interactive games with two interactive games and physical taks and activities along with voice commands generated by a voice assistant (6 weeks and duration 30-45 minutes) |
| Comparator Agent |
Regular daily activities |
GROUP B- Regular daily activities and routines (6 weeks for daily basis no restricted duration) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Typical children aged 5-7 years.
Speaking and understanding Hindi or
English language. |
|
| ExclusionCriteria |
| Details |
Children with delayed development.
Children with any neurological conditions
(cerebral palsy, seizures, GBS, etc).
Children with any orthopedic conditions.
Children with any congenital conditions.
Children with any sensory seeking or
avoiding behavior |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Attention
Coordination
Hand-eye Coordination |
At baseline and end of 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Upper limb Coordination
Lower limb Coordination |
At baseline and end of 6th week |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
16/06/2025 |
| 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="4"
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
|
The study titled "Effect of Interactive Games with Voice assistant-activated Commands on children’s
attention, coordination, and hand-eye coordination. The study will be conducted to determine the effect of interactive games and
voice assistant-generated commands on attention, coordination, and hand-eye coordination.
Initially, 68 children will be recruited and then randomly allocated into two groups, each group with 34 participants. The assessment of attention, coordination- for upper and lower extremity coordination respectively, and hand-eye coordination will be done at baseline. One group will undergo the intervention while the other will follow regular daily activities. Assessments of all the outcomes will be done after 6 weeks for both groups. Statistical analysis will utilize descriptive statistics and independent and paired t-tests for normally distributed data. |