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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04156607
Other study ID # 2018/05-23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2018
Est. completion date May 15, 2018

Study information

Verified date November 2019
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 15, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 20 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesio taping
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 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.

Locations

Country Name City State
Turkey Dokuz Eylül University I?zmi?r Balçova

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

Tütün Yümin 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Static balance 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.
Primary 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. 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.
Primary Static balance 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.
Primary 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. Dynamic balance evaluated with Timed Up and Go test for Down syndrome children immediately after the taping application. This test takes 1-2 minutes.
Primary Static balance 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.
Primary 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. 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.
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