NCT04156607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

October 29, 2019

Last Update Submit

November 6, 2019

Conditions

Keywords

Down SyndromePostural BalanceKinesio Taping

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (3)

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.

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

Other: Sham taping

Healty control group

NO INTERVENTION

This group took no intervention but all balance assessments once.

Interventions

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%).

Kinesio taping group (KT)

''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.

Sham taping group (ST)

Eligibility Criteria

Age6 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Not having any orthopedic or neurological disorder
  • To understand and do the commands given
  • Being willing to participate in the study
  • 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.

You may not qualify if:

  • Auditory and visual problems (not using glasses)
  • Operated in last 6 months prior to he study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related 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.

    PMID: 31301057BACKGROUND
  • 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.

    PMID: 11313452BACKGROUND
  • 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.

    PMID: 28095093BACKGROUND
  • 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.

    PMID: 31379969BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Half of the children with DS (Sham taping group) took sham taping application.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 7, 2019

Study Start

February 25, 2018

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations