NCT03541070

Brief Summary

Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

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

June 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 15, 2018

Last Update Submit

May 29, 2018

Conditions

BalanceDuchenne Muscular Dystrophy

Keywords

kinesiology tapingbalanceDuchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Balance Test-Timed up and go test

    Timed up and go test is a valid and practical objective measure for the pediatric population that measuring various components such as walking speed, postural control, functional mobility and balance. The children were asked to stand up from a chair, walk during 3 meters, turn, and walk back to chair and sit down. This time was recorded as second

    About 15 seconds

Secondary Outcomes (2)

  • Pediatric Berg Balance Test

    15 minutes

  • duration in standing on one leg

    about 1 minute

Study Arms (1)

Kinesiology taping

EXPERIMENTAL

For tibialis anterior muscle taping, each children's feet were placed at plantar flexion and eversion position while knees were extended, and I-shaped band was applied over tibialis anterior from origin to insertion of muscle with approximately 25-50% tension of the original length of the band. No tension was applied to the first and last 5 cm section of the bands in both applications because it were used as anchor. The tapes were remained for 1 hour on skin of both quadriceps and tibialis anterior muscles, and in this time the children were rested.

Device: Kinesiology tape

Interventions

Kinesiology tapeDEVICE

Kinesiology taping (KT) was developed by Kenzo Kase in the 1970s. KT has similar thickness and flexibility to the skin. These tapes are used in orthopedic and sports injuries as well as neurological and rheumatic diseases, pediatric patients, lymph edema and painful conditions. These tapes are used for correcting muscle function, increasing circulation, increasing proprioception, reducing pain, and repositioning the sublease joint according to the usage method

Kinesiology taping

Eligibility Criteria

Age5 Years - 14 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • DMD diagnosis being Level I and II according to Brooke Lower Extremity Functional Classification no cooperation problem no injury or orthopedic/neurologic surgery within the past 6 months no severe contracture at ankle

You may not qualify if:

  • children who did not meet the above criteria were not included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Güllü Aydın, R.A

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • İpek Alemdaroğlu Gürbüz, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Öznur Yılmaz, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Ayşe Karaduman, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Numan Bulut, R.A

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Haluk Topaloğlu, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Güllü AYDIN

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 30, 2018

Study Start

June 10, 2017

Primary Completion

September 15, 2017

Study Completion

November 10, 2017

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

TU(1)