Effects of Down Dog Yoga on Pre-writing Skills in Children With Down Syndrome

NCT ID: NCT06977672

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

Study Groups

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Yoga exercise group

This 10-week study includes assessments before and after an 8-week dog down yoga intervention. Sessions occur 3-4 times weekly, with expert-led (40-45 min) and parent-led (20-25 min) formats.

Group Type EXPERIMENTAL

Down Dog Yoga

Intervention Type OTHER

In this study, a period of 10 weeks, commencing with a preliminary assessment during the first week, followed by an 8-week intervention phase, and concluding with a final assessment in the last week of the study period. The frequency-intensity-time-type principle will be implemented as follows: sessions will occur 4 times per week, consisting of 2 sessions led by experts and 2 sessions involving parents. The intensity will be 40 to 45 minutes for expert-led sessions and 20 to 25 minutes for parent-led sessions. These sessions will take place 3 or 4 times per week over an 8-week period, focusing on a type of intervention known as dog down yoga

routine therapy group

Children attended 20-minute group sessions four days a week for 10 weeks. Writing assessment comprised across four stages: pre-phonemic, semi-phonemic, phonemic, and conventional.

Group Type OTHER

Traditional

Intervention Type OTHER

The children took part in group sessions four days a week over a span of 10 weeks, totaling 40 sessions. Each session, lasting around 20 minutes, involved small groups of four to seven children. The aim will be to evaluate the children's writing across four stages of development: pre-phonemic, semi-phonemic, phonemic, and conventional

Interventions

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Down Dog Yoga

In this study, a period of 10 weeks, commencing with a preliminary assessment during the first week, followed by an 8-week intervention phase, and concluding with a final assessment in the last week of the study period. The frequency-intensity-time-type principle will be implemented as follows: sessions will occur 4 times per week, consisting of 2 sessions led by experts and 2 sessions involving parents. The intensity will be 40 to 45 minutes for expert-led sessions and 20 to 25 minutes for parent-led sessions. These sessions will take place 3 or 4 times per week over an 8-week period, focusing on a type of intervention known as dog down yoga

Intervention Type OTHER

Traditional

The children took part in group sessions four days a week over a span of 10 weeks, totaling 40 sessions. Each session, lasting around 20 minutes, involved small groups of four to seven children. The aim will be to evaluate the children's writing across four stages of development: pre-phonemic, semi-phonemic, phonemic, and conventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yusra Uzlifat, MS-PPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Rising Sun Institute

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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IMRAN AMJAD, PhD

Role: CONTACT

9233224390125

Asif Javed, MS-PT

Role: CONTACT

923224209422

Facility Contacts

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Muhammad Asif Javed, MS-PT(Neuro)

Role: primary

923224209422

References

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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.

Reference Type BACKGROUND
PMID: 34511385 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/24/0734

Identifier Type: -

Identifier Source: org_study_id

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