Down SyndromeNCT04156607
The Effects of Kinesiotaping on Balance in Children With Down Syndrome.
A study testing Kinesio taping in people with Down Syndrome and Balance, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to explore the effects of Kinesio tape applied to plantar soles on balance in children with Down Syndrome (DS). Two groups including children with DS and a group with their typically developing peers evaluated. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Balance
- What is being tested?
- Kinesio taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2018to 15 May 2018
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Auditory and visual problems (not using glasses)
- Operated in last 6 months prior to he study
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to explore the effects of Kinesio tape applied to plantar soles on balance in children with Down Syndrome (DS). Two groups including children with DS and a group with their typically developing peers evaluated. Half of the children with DS took Kinesio tape application to the plantar soles and the other half took sham taping application. All children evaluated with dynamic and static balance measurements and DS children evaluated immediately after taping and 45 minutes after taping again with the same measurements.
Read the detailed description
Balance is one of the most problematic issues in children with DS. Mechanoreceptors of plantar region of the foot helps to regulate human erect posture and balance. Studies shows that inputs from foot sole give a positive effect in improving balance both in healthy and neurologically demaged subjects. Kinesio tape is a supportive method in physiotherapy with it's proprioceptive input giving effects. It is aimed to show the acute effects of Kinesio tape on balance parameters in children with DS.
- Conditions
- Down Syndrome, Balance
- Being tested
- Kinesio taping, Sham taping
- Keywords
- Down Syndrome, Postural Balance, Kinesio Taping
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
For the fascia technique, one part of the band which were divided by 4 fans is adhered on Achilles tendon to the heel with a 0% stretch. Then the plantar fascia was stretched by the examiner and the toes were extended (ankle dorsiflexion, toe extension) and the divided part of the band was applied toward the metatarsal heads with paper-off technique (5-15%).
Sham tapingOther
''I'' bant were cut from the middle point of the Achilles tendon to the metatarsal heads. The band was applied from the Achilles tendon to the metatarsal heads without any stretching of plantar fascia and band.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping group (KT) | Experimental | Kinesio taping applied to plantar soles of these children with Down Syndrome. Epidermis-Dermis-Fascia technique was used for providing sensory input from soles.
The application was performed on both feet. Receives: Other: Kinesio taping |
| Sham taping group (ST) | Sham comparator | A random taping was performed using Kinesio tape but without using Kinesiotaping techniques for sham taping. The application was performed on both feet Receives: Other: Sham taping |
| Healty control group | No intervention | This group took no intervention but all balance assessments once. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance
Static balance is the ability to keep the body upward without falling when the person is not moving.
Measured: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children before the randomization and taping application. The healthy control group took this test once. This test takes 1-2 minutes.
Functional (dynamic) balance
Dynamic balance is the ability to keep the body upward without falling when the person is moving and in challenging conditions like walking, running, jumping, reaching etc.
Measured: Dynamic balance evaluated with Timed Up and Go for Down syndrome children before the randomization and taping application. The healthy control group took this test once. This test takes 1-2 minutes.
Static balance
Static balance is the ability to keep the body upward without falling when the person is not moving.
Measured: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children immediately after the taping application. This test takes 1-2 minutes.
Functional (dynamic) balance
Dynamic balance is the ability to keep the body upward without falling when the person is moving and in challenging conditions like walking, running, jumping, reaching etc.
Measured: Dynamic balance evaluated with Timed Up and Go test for Down syndrome children immediately after the taping application. This test takes 1-2 minutes.
Static balance
Static balance is the ability to keep the body upward without falling when the person is not moving.
Measured: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children 45 minutes after the taping application. This test takes 1-2 minutes.
Functional (dynamic) balance
Dynamic balance is the ability to keep the body upward without falling when the person is moving and in challenging conditions like walking, running, jumping, reaching etc.
Measured: Dynamic balance evaluated with Timed Up and Go test for Down syndrome children 45 minutes after the taping application. This test takes 1-2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start25 Feb 2018
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Gazi 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
- Model description
- The study was carried out with the participation of 3 groups as kinesio taping application group with Down Sydnrome children (KT) (n=12, DS), sham taping application group with Down Syndrome children (ST) (n=12, DS) and healthy control with healty children (HC) (n=12). Healty children took no taping applications. KT group took Kinesio tape, ST group took sham taping evaluated 2 times after the tapings (immediately and 45 minutes later).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pelin atalan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156607
- Sponsor's protocol ID
- 2018/05-23
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alsakhawi 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 31301057Kavounoudias A, Roll R, Roll JP. Foot sole and ankle muscle inputs contribute jointly to human erect posture regulation. J Physiol. 2001 May 1;532(Pt 3):869-78. doi: 10.1111/j.1469-7793.2001.0869e.x.
PubMed 11313452Tutun Yumin E, Simsek TT, Sertel M, Ankarali H, Yumin M. The effect of foot plantar massage on balance and functional reach in patients with type II diabetes. Physiother Theory Pract. 2017 Feb;33(2):115-123. doi: 10.1080/09593985.2016.1271849. Epub 2017 Jan 17.
PubMed 28095093Hu Y, Zhong D, Xiao Q, Chen Q, Li J, Jin R. Kinesio Taping for Balance Function after Stroke: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jul 16;2019:8470235. doi: 10.1155/2019/8470235. eCollection 2019.
PubMed 31379969
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Kinesiotaping on Balance in Children With Down Syndrome.
- ClinicalTrials.gov ID
- NCT04156607
- Acronym / sponsor ID
- 2018/05-23
- Conditions
- Down Syndrome, Balance
- Keywords
- Down Syndrome, Postural Balance, Kinesio Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 7 Nov 2019 (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.
This study aimed to explore the effects of Kinesio tape applied to plantar soles on balance in children with Down Syndrome (DS). Two groups including children with DS and a group with their typically developing peers evaluated. Half of the children with DS took Kinesio tape application to the plantar soles and the other half took sham taping application. All children evaluated with dynamic and static balance measurements and DS children evaluated immediately after taping and 45 minutes after taping again with the same measurements.
Detailed description
Balance is one of the most problematic issues in children with DS. Mechanoreceptors of plantar region of the foot helps to regulate human erect posture and balance. Studies shows that inputs from foot sole give a positive effect in improving balance both in healthy and neurologically demaged subjects. Kinesio tape is a supportive method in physiotherapy with it's proprioceptive input giving effects. It is aimed to show the acute effects of Kinesio tape on balance parameters in children with DS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study was carried out with the participation of 3 groups as kinesio taping application group with Down Sydnrome children (KT) (n=12, DS), sham taping application group with Down Syndrome children (ST) (n=12, DS) and healthy control with healty children (HC) (n=12). Healty children took no taping applications. KT group took Kinesio tape, ST group took sham taping evaluated 2 times after the tapings (immediately and 45 minutes later).
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping group (KT) | Experimental | Other: Kinesio tapingKinesio taping applied to plantar soles of these children with Down Syndrome. Epidermis-Dermis-Fascia technique was used for providing sensory input from soles. The application was performed on both feet. |
| Sham taping group (ST) | Sham comparator | Other: Sham tapingA random taping was performed using Kinesio tape but without using Kinesiotaping techniques for sham taping. The application was performed on both feet |
| Healty control group | No intervention | –This group took no intervention but all balance assessments once. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Auditory and visual problems (not using glasses)
- Operated in last 6 months prior to he study
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 |
|---|---|---|
| Kinesio tapingFor the fascia technique, one part of the band which were divided by 4 fans is adhered on Achilles tendon to the heel with a 0% stretch. Then the plantar fascia was stretched by the examiner and the toes were extended (ankle dorsiflexion, toe extension) and the divided part of the band was applied toward the metatarsal heads with paper-off technique (5-15%). | Other | Kinesio taping group (KT) |
| Sham taping''I'' bant were cut from the middle point of the Achilles tendon to the metatarsal heads. The band was applied from the Achilles tendon to the metatarsal heads without any stretching of plantar fascia and band. | Other | Sham taping group (ST) |
Primary outcome
Static balance
Time frame: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children before the randomization and taping application. The healthy control group took this test once. This test takes 1-2 minutes.
Static balance is the ability to keep the body upward without falling when the person is not moving.
Functional (dynamic) balance
Time frame: Dynamic balance evaluated with Timed Up and Go for Down syndrome children before the randomization and taping application. The healthy control group took this test once. This test takes 1-2 minutes.
Dynamic balance is the ability to keep the body upward without falling when the person is moving and in challenging conditions like walking, running, jumping, reaching etc.
Static balance
Time frame: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children immediately after the taping application. This test takes 1-2 minutes.
Static balance is the ability to keep the body upward without falling when the person is not moving.
Functional (dynamic) balance
Time frame: Dynamic balance evaluated with Timed Up and Go test for Down syndrome children immediately after the taping application. This test takes 1-2 minutes.
Dynamic balance is the ability to keep the body upward without falling when the person is moving and in challenging conditions like walking, running, jumping, reaching etc.
Static balance
Time frame: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children 45 minutes after the taping application. This test takes 1-2 minutes.
Static balance is the ability to keep the body upward without falling when the person is not moving.
Functional (dynamic) balance
Time frame: Dynamic balance evaluated with Timed Up and Go test for Down syndrome children 45 minutes after the taping application. This test takes 1-2 minutes.
Dynamic balance is the ability to keep the body upward without falling when the person is moving and in challenging conditions like walking, running, jumping, reaching etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- 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.
- Background: PubMed 11313452Kavounoudias A, Roll R, Roll JP. Foot sole and ankle muscle inputs contribute jointly to human erect posture regulation. J Physiol. 2001 May 1;532(Pt 3):869-78. doi: 10.1111/j.1469-7793.2001.0869e.x.
- Background: PubMed 28095093Tutun Yumin E, Simsek TT, Sertel M, Ankarali H, Yumin M. The effect of foot plantar massage on balance and functional reach in patients with type II diabetes. Physiother Theory Pract. 2017 Feb;33(2):115-123. doi: 10.1080/09593985.2016.1271849. Epub 2017 Jan 17.
- Background: PubMed 31379969Hu Y, Zhong D, Xiao Q, Chen Q, Li J, Jin R. Kinesio Taping for Balance Function after Stroke: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jul 16;2019:8470235. doi: 10.1155/2019/8470235. eCollection 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping in people with Down Syndrome and Balance, run by Gazi University at 1 site in Turkey (Türkiye).
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 0 inclusion and 2 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: finished, as of the sponsor's last update on 7 Nov 2019. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance (time frame: Static balance evaluated with Modified Clinical test of Sensory Interaction on Balance (MCTSIB) for Down syndrome children before the randomization and taping application. The healthy control group took this test once. This test takes 1-2 minutes.). The study lists 6 primary outcomes in all. 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 NCT04156607, which also lists 4 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 7 Nov 2019.