- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03529240
Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption
May 17, 2018 updated by: Güllü AYDIN, Hacettepe University
Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics 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.
Performance was assessed by measuring the distance in 6-minute walk test (6MWT) and the duration of timed performance tests; energy consumption by Physiological Consumption Index (PCI), and gait characteristics by footprint method on powdered ground at baseline.
Kinesiology taping 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
-
-
Sıhhiye
-
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:
- Duchenne Muscular Dystrophy diagnosis,
- age 5 to 14 years,
- able to cooperate with instructions of physiotherapist,
- able to walk independently,
- climb 4 steps independently/with minimal support from handrails.
Exclusion Criteria:
- severe contracture at lower extremities,
- other disease except for DMD, and
- history of any injury or orthopaedic/neurologic surgery within the past 6 months.
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
After performing the baseline assessments, kinesiology taping with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles of children.
In both applications, the first and last 5 cm section of the bands were used as anchor and no tension was applied.
|
Kinesiology taping (KT) which was developed by Dr. Kenzo Kase, is a new application of elastic and adhesive taping.
KT is applied by specialized physiotherapists and physicians.
This type of taping is a very frequently used technique to accelerate recovery after musculoskeletal injuries.
Also, this technique is usually used as an alternative to athletic taping to support fascias, muscles, and joints for many purpose such as positioning, inhibition, and fascilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Minute Walk Test
Time Frame: 6 minute
|
Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic.
Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT.
The time passed during timed performance tests were recorded as seconds.
|
6 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy Consumption
Time Frame: 6 minutes
|
Physiologic Consumption Index (PCI) was used to evaluate energy consumption of children during 6MWT.
energy consumption was calculated by using the formula of PCI (walking heart rate)-(resting heart rate)/(walking speed)
|
6 minutes
|
Gait
Time Frame: 2 minutes
|
Gait analysis of the children was performed by footprint method on 10-meters powdered floor.
First and last 2 meters of this floor were dissociated from the assessment, and both the right and left stride lengths, both right and left foot angles, and stride width were analyzed in the middle 6-meter section.. Stride length was measured by measuring the distance between right and left midpoint heels.
Double stride length was sum of right and left stride length.
Stride width was measured by horizontal distance between heel midpoints.
Foot angles were measured by a goniometer considering the line between the first and second metatarsal heads and the heel midpoints of both feet separately 24.
The number of steps during 6MWT was also calculated by pedometer (Omron, Walking style One 2.0 HJ-320-E) and recorded.
|
2 minutes
|
Timed Performance Test
Time Frame: 10 minutes
|
Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşe Karaduman, Prof., Hacettepe University
- Principal Investigator: Güllü Aydın, R.A, Hacettepe University
- Study Director: İpek Alemdaroğlu Gürbüz, Assoc. Prof., 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)
August 5, 2017
Study Completion (Actual)
October 5, 2017
Study Registration Dates
First Submitted
May 6, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 18, 2018
Study Record Updates
Last Update Posted (Actual)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 17, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-17070
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.
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