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The Effects of Kinesiotaping on Balance in Children With Down Syndrome.

Primary Purpose

Down Syndrome, Balance

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Kinesio taping

Sham taping

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Down Syndrome, Postural Balance, Kinesio Taping

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Kinesio taping group (KT)

Sham taping group (ST)

Healty control group

Arm Description

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.

A random taping was performed using Kinesio tape but without using Kinesiotaping techniques for sham taping. The application was performed on both feet

This group took no intervention but all balance assessments once.

Outcomes

Primary Outcome Measures

Static balance

Static balance is the ability to keep the body upward without falling when the person is not moving.

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.

Static balance

Static balance is the ability to keep the body upward without falling when the person is not moving.

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.

Static balance

Static balance is the ability to keep the body upward without falling when the person is not moving.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04156607

First Posted

October 29, 2019

Last Updated

November 6, 2019

Sponsor

Gazi University

1. Study Identification

Unique Protocol Identification Number

NCT04156607

Brief Title

The Effects of Kinesiotaping on Balance in Children With Down Syndrome.

Official Title

The Effects of Kinesiotaping on Balance in Children With Down Syndrome.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

February 25, 2018 (Actual)

Primary Completion Date

May 15, 2018 (Actual)

Study Completion Date

May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome, Balance

Keywords

Down Syndrome, Postural Balance, Kinesio Taping

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

Half of the children with DS (Sham taping group) took sham taping application.

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kinesio taping group (KT)

Arm Type

Experimental

Arm Description

Arm Title

Sham taping group (ST)

Arm Type

Sham Comparator

Arm Description

A random taping was performed using Kinesio tape but without using Kinesiotaping techniques for sham taping. The application was performed on both feet

Arm Title

Healty control group

Arm Type

No Intervention

Arm Description

This group took no intervention but all balance assessments once.

Intervention Type

Other

Intervention Name(s)

Kinesio taping

Intervention Description

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%).

Intervention Type

Other

Intervention Name(s)

Sham taping

Intervention Description

''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.

Primary Outcome Measure Information:

Title

Static balance

Description

Static balance is the ability to keep the body upward without falling when the person is not moving.

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.

Title

Functional (dynamic) balance

Description

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.

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.

Title

Static balance

Description

Static balance is the ability to keep the body upward without falling when the person is not moving.

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.

Title

Functional (dynamic) balance

Description

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.

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.

Title

Static balance

Description

Static balance is the ability to keep the body upward without falling when the person is not moving.

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.

Title

Functional (dynamic) balance

Description

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.

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Dokuz Eylül University

City

İ̇zmi̇r

State/Province

Balçova

ZIP/Postal Code

35330

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31301057

Citation

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.

Results Reference

background

PubMed Identifier

11313452

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. doi: 10.1111/j.1469-7793.2001.0869e.x.

Results Reference

background

PubMed Identifier

28095093

Citation

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.

Results Reference

background

PubMed Identifier

31379969

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.

Results Reference

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The Effects of Kinesiotaping on Balance in Children With Down Syndrome.

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