- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541070
The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy
May 29, 2018 updated by: Güllü AYDIN, Hacettepe University
Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional Classification were included in the study.
Balance was assessed by Pediatric Berg Balance Test (PBBT), Timed and Go Test (TUGT), and standing on one leg test.
Kinesiology taping (KT) with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour after application.
The comparison between before and after taping was analyzed.
Study Type
Interventional
Enrollment (Actual)
45
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
-
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Sıhhiye
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Ankara, Sıhhiye, Turkey, 06100
- Hacettepe 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
5 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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
Exclusion Criteria:
children who did not meet the above criteria were not included
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesiology taping
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.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Test-Timed up and go test
Time Frame: About 15 seconds
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Berg Balance Test
Time Frame: 15 minutes
|
Pediatric Berg Balance Test is a modified version of the Berg Balance Scale that a valid and reliable test for the elderly population, for children in school age with mild to moderate motor impairment.
The patients were asked to maintain their balance at the positions indicated in the test.
The score of each item varies according to the parameters of the test.
The score of this test is between 0-4 and the highest total score is 56.
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15 minutes
|
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duration in standing on one leg
Time Frame: about 1 minute
|
Duration in standing on right and left leg was recorded as second
|
about 1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İpek Alemdaroğlu Gürbüz, Assoc. Prof., Hacettepe University
- Principal Investigator: Ayşe Karaduman, Prof., Hacettepe University
- Principal Investigator: Güllü Aydın, R.A, Hacettepe University
- Principal Investigator: Öznur Yılmaz, Prof., Hacettepe University
- Principal Investigator: Numan Bulut, R.A, Hacettepe University
- Principal Investigator: Haluk Topaloğlu, Prof., Hacettepe University
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)
June 10, 2017
Primary Completion (Actual)
September 15, 2017
Study Completion (Actual)
November 10, 2017
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
May 29, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
May 30, 2018
Last Update Submitted That Met QC Criteria
May 29, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-17070-1
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.