Down SyndromeNCT05719662
Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training in Children With Down Syndrome.
A study testing Weight bearing exercises and Jaffrey's core stability exercises in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Down syndrome also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. There is no cure for Down syndrome. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Weight bearing exercises and Jaffrey's core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with medical diagnosis of DS
- Age ranging from 4 to 10 year
- Both male and female genders
- Children who was able to stand and walk.
Who cannot join
- Any orthopedic limitation to exercise such as hip, knee, foot or spinal deformity.
- Children with planned orthopedic surgery in 6 months.
- Children with significantly impaired cognition.
- Children with hearing impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province
Sana Shahzadi, MS
About this study
Official title: Effects of Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training on Dynamic Balance and Trunk Muscles Strength in Children With Down Syndrome.
Down syndrome also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. There is no cure for Down syndrome. Education and proper care have been shown to improve quality of life. Some children with Down syndrome are educated in typical school classes, while others require more specialized education. Those with Down syndrome nearly always have physical and intellectual disabilities. They also typically have poor immune function and generally reach developmental milestones at a later age. They have an increased risk of a number of other health problems, including congenital heart defect, epilepsy, leukemia, thyroid diseases, and mental disorders. This study will determine effects of weight bearing exercises with and without Jaffery's core stability exercise training on dynamic balance and trunk muscles strength in children with Down syndrome. Randomized controlled study will be conducted in which data will be collected from children with down syndrome with calculated sample size of 18 which will randomly assigned into group A and group B. Group A would receive weight bearing exercises (I.e.
standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam ).Group B would receive weight bearing exercises along with the jaffrey's core stability exercises (I.e.
contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc.).Frequency will be 5 sessions per week, of 1 hour and duration is of 5 months. Balance and trunk muscle strength will be pre assessed using pediatric balance scale and trunk control measurement scale respectively. The improvement will be measured with same tools. Data will be analyzed through SPSS 25.
- Conditions
- Down Syndrome
- Being tested
- Weight bearing exercises, Jaffrey's core stability exercises
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight bearing exercisesOther
Weight bearing exercises
Jaffrey's core stability exercisesOther
Jaffrey's core stability exercises
| Study group | Role | What they receive |
|---|---|---|
| Weight bearing exercises | Experimental | weight bearing exercises (I.e standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam). Receives: Other: Weight bearing exercises |
| Jaffrey's core stability exercises | Experimental | Jaffrey's core stability exercises (I.e contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc). Receives: Other: Jaffrey's core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric baalnce scale
Pediatric balance scale (PBS), is defined as the ability of a child to attain and maintain upright control. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: 4 weeks
Trunk Control Measurement Scale
Trunk Control Measurement Scale is a clinical tool to measure trunk control in children
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start10 Feb 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Khan, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719662
- Sponsor's protocol ID
- REC/RCR & AHS/22/0748
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training on Dynamic Balance and Trunk Muscles Strength in Children With Down Syndrome.
- ClinicalTrials.gov ID
- NCT05719662
- Acronym / sponsor ID
- REC/RCR & AHS/22/0748
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Feb 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 9 Feb 2023 (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 also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. There is no cure for Down syndrome. Education and proper care have been shown to improve quality of life. Some children with Down syndrome are educated in typical school classes, while others require more specialized education. Those with Down syndrome nearly always have physical and intellectual disabilities. They also typically have poor immune function and generally reach developmental milestones at a later age. They have an increased risk of a number of other health problems, including congenital heart defect, epilepsy, leukemia, thyroid diseases, and mental disorders. This study will determine effects of weight bearing exercises with and without Jaffery's core stability exercise training on dynamic balance and trunk muscles strength in children with Down syndrome. Randomized controlled study will be conducted in which data will be collected from children with down syndrome with calculated sample size of 18 which will randomly assigned into group A and group B. Group A would receive weight bearing exercises (I.e.
standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam ).Group B would receive weight bearing exercises along with the jaffrey's core stability exercises (I.e.
contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc.).Frequency will be 5 sessions per week, of 1 hour and duration is of 5 months. Balance and trunk muscle strength will be pre assessed using pediatric balance scale and trunk control measurement scale respectively. The improvement will be measured with same tools. Data will be analyzed through SPSS 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight bearing exercises | Experimental | Other: Weight bearing exercisesweight bearing exercises (I.e standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam). |
| Jaffrey's core stability exercises | Experimental | Other: Jaffrey's core stability exercisesJaffrey's core stability exercises (I.e contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc). |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with medical diagnosis of DS
- Age ranging from 4 to 10 year
- Both male and female genders
- Children who was able to stand and walk.
Key exclusion criteria (4 listed)
- Any orthopedic limitation to exercise such as hip, knee, foot or spinal deformity.
- Children with planned orthopedic surgery in 6 months.
- Children with significantly impaired cognition.
- Children with hearing impairment
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 |
|---|---|---|
| Weight bearing exercisesWeight bearing exercises | Other | Weight bearing exercises |
| Jaffrey's core stability exercisesJaffrey's core stability exercises | Other | Jaffrey's core stability exercises |
Primary outcome
Pediatric baalnce scale
Time frame: 4 weeks
Pediatric balance scale (PBS), is defined as the ability of a child to attain and maintain upright control. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Trunk Control Measurement Scale
Time frame: 4 weeks
Trunk Control Measurement Scale is a clinical tool to measure trunk control in children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- 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. This study is not recruiting at the moment.
Sara Khan, MS 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 Weight bearing exercises and Jaffrey's core stability exercises 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, phd (03324390125, 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?
Pediatric baalnce scale (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2023.