- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156607
The Effects of Kinesiotaping on Balance in Children With Down Syndrome.
November 6, 2019 updated by: pelin atalan, Gazi University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Balçova
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İ̇zmi̇r, Balçova, Turkey, 35330
- Dokuz Eylül University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
The inclusion criteria for healthy children:
- Not having any orthopedic or neurological disorder
- To understand and do the commands given
- Being willing to participate in the study
The inclusion criteria for children with DS:
- To have diagnosis of DS
- Not having any orthopedic or neurological disorder in addition the DS
- To understand and do the commands given
- Being willing to participate in the study.
Exclusion criteria for all children:
- Auditory and visual problems (not using glasses)
- Operated in last 6 months prior to he study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesio taping group (KT)
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. |
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 Comparator: Sham taping group (ST)
A random taping was performed using Kinesio tape but without using Kinesiotaping techniques for sham taping.
The application was performed on both feet
|
''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.
|
|
No Intervention: Healty control group
This group took no intervention but all balance assessments once.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kavounoudias 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.
- Tutun 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.
- Hu 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2018
Primary Completion (Actual)
May 15, 2018
Study Completion (Actual)
May 15, 2018
Study Registration Dates
First Submitted
October 29, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 7, 2019
Study Record Updates
Last Update Posted (Actual)
November 7, 2019
Last Update Submitted That Met QC Criteria
November 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/05-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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