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

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ClinicalTrials.gov Identifier: NCT03589612
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Lütfiye AKKURT, PT, 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. Correlation was examined between popliteal angle test and parameter of North Star Ambulation Assessment.

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Study Type : Observational
Actual Enrollment : 60 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
Actual Primary Completion Date : January 24, 2019
Actual Study Completion Date : January 24, 2019





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.

  2. North Star Ambulation Assessment [ Time Frame: 20 minute ]
    The North Star Ambulatory Assessment (NSAA) is used to assess mobility for in ambulatory children with DMD for 5 years. NSAA is consist of 17 items from stand to run.



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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03589612


Locations
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Turkey
Hacettepe University
Ankara, Sıhhiye, Turkey
Sponsors and Collaborators
Hacettepe University
Investigators
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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
Study Director: Oznur Yılmaz Hacettepe University

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Responsible Party: Lütfiye AKKURT, PT, Principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03589612     History of Changes
Other Study ID Numbers: GO 16/740-2
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
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, PT, Hacettepe University:
Duchenne Muscular Dystrophy
performance
hamstring flexibility
regression
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