NCT03529240

Brief Summary

Investigators investigated that the effects of kinesilogy taping on performance, energy consumption and gait characteristics 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 6, 2018

Last Update Submit

May 17, 2018

Conditions

Keywords

kinesiology tapingperformanceenergy consumptiongaitDuchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Energy Consumption

    6 minutes

  • Gait

    2 minutes

  • Timed Performance Test

    10 minutes

Study Arms (1)

Kinesiology taping

EXPERIMENTAL

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.

Device: Kinesiology Taping

Interventions

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

Kinesiology taping

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • severe contracture at lower extremities,
  • other disease except for DMD, and
  • history of any injury or orthopaedic/neurologic surgery within the past 6 months.

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

    STUDY DIRECTOR
  • 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 6, 2018

First Posted

May 18, 2018

Study Start

June 10, 2017

Primary Completion

August 5, 2017

Study Completion

October 5, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations