Clinical trial NCT06977672: Effects of Down Dog Yoga on Pre-writing Skills in Children With Down Syndrome
Official title: Effects of Down Dog Yoga on Pre-writing Skills in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Down Dog yoga
JTHFT
BBT
pre-writing skills
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study involves two groups of children: an experimental group (Group A) and a control group (Group B), to compare the effects of a yoga-based intervention with standard educational activities. Group A will follow a 10-week program, including an initial and final assessment, with an 8-week intervention in between. They will participate in down dog yoga sessions four times a week-two expert-led (40-45 minutes) and two parent-led (20-25 minutes). Group B will attend regular writing sessions, four times a week for 20 minutes, in small groups. Their writing will be assessed across four developmental stages: pre-phonemic, semi-phonemic, phonemic, and conventional. The study aims to evaluate developmental differences between the two approaches.
Primary purpose: OTHER

Brief summary: Down syndrome is a genetic condition caused by an extra chromosome 21, affecting physical and cognitive development. This study will evaluate the effects of down dog yoga on prewriting skills in children with Down syndrome aged 4-8 years. A randomized controlled trial with 32 participants will be conducted at Bahawal Victoria Hospital over 10 months. Assessments will include JTHFT, BBT, and the Prewriting Skills Scale.

Detailed description: Down syndrome is a genetic condition where people are born with an extra chromosome. Most people have 23 pairs of chromosomes within each cell in their body, for a total of 46. A person diagnosed with Down syndrome has an extra copy of chromosome 21, which means their cells contain 47 total chromosomes instead of 46. This changes the way their brain and body develop. Down syndrome causes physical, cognitive and behavioral symptoms. Down syndrome occurs in approximately 1 in 1,000 to 1 in 1,100 live births globally. Each year, around 3,000 to 5,000 children are born with this genetic condition characterized by an extra chromosome. Children with Down syndrome may experience challenges with fine motor skills because of low muscle tone or hypermobility in their hands, wrists, or elbows. This instability in their hands can significantly hinder their ability to perform advanced fine motor tasks such as prewriting, using zippers and buttons, or cutting. Early intervention refers to a structured approach involving therapy, exercises, and activities aimed at addressing developmental delays in children with Down syndrome or other disabilities. For addressing pre writing skills in Down syndrome Down dog yoga will be provided.

The study design will be Randomized Controlled Trial and will be conducted in Bahawal Victoria Hospital with the sample size of 34, age ranging 4 to 8 years. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenient sampling technique will be used and participants will be recruited in study after randomization. The subjects will be divided into two groups i.e one being experimental group and the other control group. Inclusion criteria will be including both genders of age group 4 to 8 years of children with down syndrome and exclusion criteria will be any deformity, injury any previous 6 month surgery. Tools will be Jebsen-Taylor Hand Function Test (JTHFT) , box and block test (BBT) and pre writing skills scale.

Reliability of JTHFT is 0.9, BBT is \>0.95 and pre writing skills is 0.91 with high variability in writing performance.

Eligibility criteria: Inclusion Criteria:

* Children with age group 4-8years
* Both Genders (male female)
* Children who can do Independent standing and walking

Exclusion Criteria:

* Any deformity
* Pain and/or symptomatic neurologic/orthopedic dysfunction of upper or lower extremities
* Cervical injury and chest wall disorders
* Injury
* Fractures
* History of previous surgery
* Children with impaired Fun

Primary outcomes:
measure: Jebsen-Taylor hand function test:
timeFrame: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
Secondary outcomes:
measure: Box and block test
timeFrame: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
Other outcomes:
measure: Pre writing skills
timeFrame: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
Locations:
city: Lahore
country: Pakistan
facility: Rising Sun Institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Yusra Uzlifat, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shields N. Physiotherapy management of Down syndrome. J Physiother. 2021 Oct;67(4):243-251. doi: 10.1016/j.jphys.2021.08.016. Epub 2021 Sep 10. No abstract available.