Down SyndromeNCT06977672
Effects of Down Dog Yoga on Pre-writing Skills in Children With Down Syndrome
A study testing Down Dog Yoga and Traditional in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Down Dog Yoga and Traditional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with age group 4-8years
- Both Genders (male female)
- Children who can do Independent standing and walking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rising Sun Institute
Lahore, Punjab Province, 54900
Muhammad Asif Javed, MS-PT(Neuro), 923224209422, a.javed@riphah.edu.pk
About this study
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Down Dog Yoga, Traditional
- Keywords
- Down Dog yoga, JTHFT, BBT, pre-writing skills
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Down Dog YogaOther
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
TraditionalOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
Secondary outcomes (1)
Box and block test
The Box and Block Test (BBT) is a quick, standardized test that measures gross manual dexterity. It involves moving as many blocks as possible from one side of a box to the other in 60 seconds, one hand at a time. It's commonly used in rehab to assess hand function in individuals with neurological conditions.
The Box and Block Test (BBT) is a quick, standardized test that measures gross manual dexterity. It involves moving as many blocks as possible from one side of a box to the other in 60 seconds, one hand at a time. It's commonly used in rehab to assess hand function in individuals with neurological conditions.
Measured: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start15 Apr 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yusra Uzlifat, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977672
- Sponsor's protocol ID
- REC/RCR & AHS/24/0734
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34511385
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Down Dog Yoga on Pre-writing Skills in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06977672
- Acronym / sponsor ID
- REC/RCR & AHS/24/0734
- Conditions
- Down Syndrome
- Keywords
- Down Dog yoga, JTHFT, BBT, pre-writing skills
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yoga exercise group | Experimental | Other: Down Dog YogaThis 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. |
| routine therapy group | Other | Other: TraditionalChildren 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. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with age group 4-8years
- Both Genders (male female)
- Children who can do Independent standing and walking
Key exclusion criteria (7 listed)
- Any deformity
- Pain and/or symptomatic neurologic/orthopedic dysfunction of upper or lower extremities
- Cervical injury and chest wall disorders
- Injury
- Fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Down Dog YogaIn 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 | Other | Yoga exercise group |
| TraditionalThe 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 | Other | routine therapy group |
Primary outcome
Jebsen-Taylor hand function test:
Time frame: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
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.
1 secondary outcome
Box and block test
Time frame: preliminary assessment 1 week, intervention 8 week, final assessment 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 34511385Shields 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.
- Individual participant dataSharing planned: No
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yusra Uzlifat, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Down Dog Yoga and Traditional in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jebsen-Taylor hand function test: (time frame: preliminary assessment 1 week, intervention 8 week, final assessment 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06977672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.