NCT06977672

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 17, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

Down Dog yogaJTHFTBBTpre-writing skills

Outcome Measures

Primary Outcomes (1)

  • Jebsen-Taylor hand function test:

    The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized assessment used to evaluate hand function through tasks that simulate everyday activities such as writing, feeding, and object manipulation. Commonly used in rehabilitation for individuals with neurological or musculoskeletal conditions like stroke, spinal cord injury, or hand trauma, the test consists of timed subtests that measure the speed and efficiency of hand use. It provides objective data to monitor functional ability, compare hand performance, and track rehabilitation progress.

    preliminary assessment 1 week, intervention 8 week, final assessment 1 week

Secondary Outcomes (1)

  • Box and block test

    preliminary assessment 1 week, intervention 8 week, final assessment 1 week

Other Outcomes (1)

  • Pre writing skills

    preliminary assessment 1 week, intervention 8 week, final assessment 1 week

Study Arms (2)

Yoga exercise group

EXPERIMENTAL

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.

Other: Down Dog Yoga

routine therapy group

OTHER

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.

Other: Traditional

Interventions

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

Yoga exercise group

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

routine therapy group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute

Lahore, Punjab Province, 54900, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34511385BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Yusra Uzlifat, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 18, 2025

Study Start

April 15, 2025

Primary Completion

June 15, 2025

Study Completion

June 30, 2025

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations