Down SyndromeNCT05460910
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
A study testing core stability exercises with treadmill and core stability exercise without treadmill in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- core stability exercises with treadmill and core stability exercise without treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 18 May 2022to 15 Nov 2022
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- able to stand and walk independently
- able to understand and follow a verbal command
- cutoff score less than 6 or 7 in functional balance in indicated
Who cannot join
- patients have any neurological issue,
- Instability of atlantoaxial joint
- Vision and hearing loss
- History of fall
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
International Therapy Services Center
Lahore, Punjab Province, 40050
wajiha shahid, phd, 03036088768, wajiha.shahid@riphah.edu.pk
maryam akram, MS (PPT)
About this study
To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome
- Conditions
- Down Syndrome
- Being tested
- core stability exercises with treadmill, core stability exercise without treadmill
- Keywords
- core stability exercises, balance, treadmill
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stability exercises with treadmillOther
swiss ball use patient is lying in supine position with 15 repitations and 3 sets.
core stability exercise without treadmillOther
technique used to improve stability
| Study group | Role | What they receive |
|---|---|---|
| core stability exercise, treadmill | Experimental | core stability exercises and treadmill training Receives: Other: core stability exercises with treadmill |
| core stability exercises | Experimental | core stability exercises without treadmill training Receives: Other: core stability exercise without treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
berg balance scale was used to measure the functional balance in children.
Measured: 8th week
Secondary outcomes (1)
Reach test
reach test is used to measure the stability in children
Measured: 8week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start18 May 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460910
- Sponsor's protocol ID
- REC/RCR & AHS/22/0712
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szafraniec R, Baranska J, Kuczynski M. Acute effects of core stability exercises on balance control. Acta Bioeng Biomech. 2018;20(4):145-151.
PubMed 30520448Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
PubMed 31301057Amini HA, Fazel Kalkhoran J, Salehi M, Jazini F. Effect of backward walking training on improves postural stability in children with down syndrome. International Journal of Pediatrics. 2016;4(7):2171-81.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05460910
- Acronym / sponsor ID
- REC/RCR & AHS/22/0712
- Conditions
- Down Syndrome
- Keywords
- core stability exercises, balance, treadmill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 15 Jul 2022 (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.
To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core stability exercise, treadmill | Experimental | Other: core stability exercises with treadmillcore stability exercises and treadmill training |
| core stability exercises | Experimental | Other: core stability exercise without treadmillcore stability exercises without treadmill training |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- able to stand and walk independently
- able to understand and follow a verbal command
- cutoff score less than 6 or 7 in functional balance in indicated
Key exclusion criteria (4 listed)
- patients have any neurological issue,
- Instability of atlantoaxial joint
- Vision and hearing loss
- History of fall
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 |
|---|---|---|
| core stability exercises with treadmillswiss ball use patient is lying in supine position with 15 repitations and 3 sets. | Other | core stability exercise, treadmill |
| core stability exercise without treadmilltechnique used to improve stability | Other | core stability exercises |
Primary outcome
Berg balance scale
Time frame: 8th week
berg balance scale was used to measure the functional balance in children.
1 secondary outcome
Reach test
Time frame: 8week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 30520448Szafraniec R, Baranska J, Kuczynski M. Acute effects of core stability exercises on balance control. Acta Bioeng Biomech. 2018;20(4):145-151.
- Background: PubMed 31301057Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
- BackgroundAmini HA, Fazel Kalkhoran J, Salehi M, Jazini F. Effect of backward walking training on improves postural stability in children with down syndrome. International Journal of Pediatrics. 2016;4(7):2171-81.
- Individual participant dataSharing planned: No
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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.
Wajiha Shahid, PhD 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 core stability exercises with treadmill and core stability exercise without treadmill 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 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 15 Jul 2022. 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 (+923324390125, 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?
Berg balance scale (time frame: 8th 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 NCT05460910, which also lists 3 linked publications.
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 15 Jul 2022.