| CTRI Number |
CTRI/2025/08/093770 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Cognition, and Behaviour in Children with Down Syndrome |
|
Scientific Title of Study
|
Impact of yoga intervention on sensory perception, cognitive abilities, and behaviour in children with Down Syndrome: A mixed-methods approach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishita Kulkarni |
| Designation |
PhD Research Scholar |
| Affiliation |
S-VYASA University |
| Address |
S-VYASA, Deemed to be University, Division of Yoga and Humanities, Jigani, Bengaluru, India
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
8983566704 |
| Fax |
|
| Email |
ishitakul15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Soubhagyalaxmi Mohanty |
| Designation |
Associate Professor |
| Affiliation |
S-VYASA University |
| Address |
S-VYASA, Deemed to be University, Division of Yoga and Humanities, Jigani, Bengaluru, India
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
9483852383 |
| Fax |
|
| Email |
soubhagyalaxmi.mohanthy@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ishita Kulkarni |
| Designation |
PhD Research Scholar |
| Affiliation |
S-VYASA University |
| Address |
S-VYASA, Deemed to be University, Division of Yoga and Humanities, Jigani, Bengaluru, India
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
8983566704 |
| Fax |
|
| Email |
ishitakul15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ishita Kulkarni |
| Address |
Prashanti Kutiram, S-VYASA University, Jigani, Bangalore, Karnataka-560105 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ishita Kulkarni |
Assisi Asha Niketan |
Fatherwadi, Padegaon road, Chhatrapati Sambhajinagar, 431 001
Aurangabad
MAHARASHTRA |
8983566704
ishitakul15@gmail.com |
| Ishita Kulkarni |
Chaitanya Kanifnath Niwasi Apang Vidyalaya |
Naregaon, Chikalthana, Chhatrapati Sambhajinagar, 431 006
Aurangabad
MAHARASHTRA |
8983566704
ishitakul15@gmail.com |
| Ishita Kulkarni |
Navjeevan School for Mentally retarded |
MIDC, Chikalthana, Chhatrapati Sambhajinagar- 431 006
Aurangabad
MAHARASHTRA |
8983566704
ishitakul15@gmail.com |
| Ishita Kulkarni |
Swayamsiddh Matimand Mulansathi Matrupalak Sanstha |
Cidco, Azad chowk, Chhatrapati Sambhajinagar, 110 032
Aurangabad
MAHARASHTRA |
8983566704
ishitakul15@gmail.com |
| Ishita Kulkarni |
Vihang Special School |
Beed bypass, Satara Parisar, Chhatrapati Sambhajinagar, 431 010
Aurangabad
MAHARASHTRA |
8983566704
ishitakul15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q909||Down syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
No intervention provided. Cognition, behavior, speech and hearing assessments will be checked pre and post intervention. |
| Intervention |
Yoga |
Validated Yoga module including Asana, Pranayama, Krida yoga, Relaxation. Duration- 4 months, Frequency-5 days/week |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of both genders studying in school.
2. Age ranged between 6 to 16 years.
3. Willing to follow study conditions.
4. The parent or caregiver is willing to provide a signed consent form.
5. Able to understand both English and regional Indian Languages (Hindi or Marathi). |
|
| ExclusionCriteria |
| Details |
1. IQ 20-35 (Severe and Profound)
2. Children with moderate-severe hearing loss (55db to 70 dB) to profound hearing loss (more than 91db).
3. Children who cannot perform the assessment task.
4. Any physical and motor impairments preventing participation in yoga.
5. If children are currently practising any mind-body practices. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensory perception, cognitive abilities, and behaviour |
Two (pre and post) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Qualitative data |
Two (pre and post) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/09/2025 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study
explores the impact of yoga on children with Down Syndrome aged 6–16 years, focusing on improving sensory perceptions, cognitive abilities, and behaviour. A specially designed 4-month yoga module will be conducted daily (Monday–Friday). The study employs a mixed-methods approach, utilising both quantitative and qualitative tools. Assessments will be conducted with the help of a psychologist and an audiologist. Parental interviews will provide deeper insights through thematic analysis. The aim is to establish yoga as a supportive intervention for children with
Down Syndrome. |