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Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03589612
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Information provided by (Responsible Party):
Lütfiye AKKURT, Hacettepe University

Brief Summary:
Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.

Condition or disease
Duchenne Muscular Dystrophy Performance Flexibility

Detailed Description:
Flexibility of hamstrings was evaluated by Popliteal Angle test. Performance was evaluated 6 Minute Walk Test (6 MWT). Regression of hamstring flexibility and performance was examined regression tests.

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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Other
Time Perspective: Other
Official Title: Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 30, 2018

Primary Outcome Measures :
  1. Popliteal Angle Test [ Time Frame: 5 minute ]
    The Popliteal Angle Test was used to assess hamstring flexibility. Child asked to rise lower leg straight. Incomplete angle degree of full extension is popliteal angle.

Secondary Outcome Measures :
  1. 6 Minute Walk Test [ Time Frame: 6 minute ]
    6 Minute Walk Test was used to assess performance with children Duchenne MUscular Dystropy.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population
Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.

Inclusion Criteria:

  • To be a Duchenne Muscular Dystrophy diagnosis,
  • Being in the ambulatory period and climbing four steps independently,
  • to be Level 1 and Level 2 according to Brooke Lower Functional Classification Test
  • To be able to cooperate
  • No any severe contracture in the lower limbs which may prevent assessments,

Exclusion Criteria:

  • Children who fail to meet these criteria study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03589612

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Contact: Lütfiye Akkurt, MsC 905548521081
Contact: Oznur Yılmaz, Prof. +903123051576 ext 145

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Hacettepe University Recruiting
Ankara, Sıhhiye, Turkey
Contact: Öznur Yılmaz, Prof.    +903123051576 ext 145   
Contact: Lütfiye Akkurt, MSc    905548521081   
Sponsors and Collaborators
Hacettepe University
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Principal Investigator: Güllü Aydın, Msc. Hacettepe University
Principal Investigator: Numan Bulut, Msc Hacettepe University
Principal Investigator: İpek Gürbüz, Assoc.Prof. Hacettepe University
Principal Investigator: Ayşe Karaduman, Prof. Hacettepe University

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Responsible Party: Lütfiye AKKURT, Principal investigator, Hacettepe University Identifier: NCT03589612     History of Changes
Other Study ID Numbers: GO 16/740-2
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lütfiye AKKURT, Hacettepe University:
Duchenne Muscular Dystrophy
hamstring flexibility

Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked