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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03529240
Other study ID # KA-17070
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2017
Est. completion date October 5, 2017

Study information

Verified date May 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics in patients with Duchenne Muscular Dystrophy


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date October 5, 2017
Est. primary completion date August 5, 2017
Accepts healthy volunteers No
Gender Male
Age group 5 Years to 14 Years
Eligibility 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 Design


Intervention

Device:
Kinesiology Taping
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

Locations

Country Name City State
Turkey Hacettepe University Ankara Sihhiye

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six Minute Walk Test 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 Energy Consumption 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
Secondary Gait 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
Secondary Timed Performance Test 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
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