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Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance

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ClinicalTrials.gov Identifier: NCT03534349
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Lütfiye AKKURT, Hacettepe University

Brief Summary:
The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy.

Condition or disease
Duchenne Muscular Dystrophy Performance Flexibility

Detailed Description:
Thirty children whose functional levels were in 1 or 2 according to the Brooke Lower Extremity Functional Classification Scale were included in the study. Flexibilities of hamstrings, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. Popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. Functional performance was assessed with 6 Minute Walk Test (6 MWT) and Timed Performance Tests. The correlation between the flexibility of lower limb muscles' and performance tests were examined.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Other
Time Perspective: Other
Official Title: Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017





Primary Outcome Measures :
  1. 6 Minute Walk Test [ Time Frame: 6 Minute ]
    The 6 Minute Walk Test (6MWT) is a standard test recently used to evaluate functional capacity in neuromuscular diseases, and found to be a safe and valid test that can be performed in Duchenne Muscular Dystrophy


Secondary Outcome Measures :
  1. Timed Performance Test [ Time Frame: 3 minute ]
    Timed performance tests such as 10 m walk, Gower's (from supine position to stand up), ascending/descending 4 steps were also performed. During these tests, the child's performance was recorded in seconds.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with ambule Duchenne Muscular Dystrophy
Criteria

Inclusion Criteria:

  • Having a Duchenne Muscular Dystrophy diagnosis,
  • Being in the ambulatory period and climbing four steps independently,
  • To be able to cooperate the physiotherapist's directions,
  • Not having any severe contracture in the lower limbs which may prevent assessments,
  • Not having any injury or surgery involving the lower limbs during the last 6 months.

Exclusion Criteria:

Children who did not provide these criteria and did not will to participate the study were excluded.


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): NCT03534349


Locations
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Turkey
Hacettepe University
Ankara, Sıhhiye, Turkey
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Öznur Tunca Yılmaz, Prof. Hacettepe University
Principal Investigator: İpek Alemdaroğlu Gürbüz, Assoc. Prof. Hacettepe University
Principal Investigator: Ayşe Karaduman, Prof. Hacettepe University

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Responsible Party: Lütfiye AKKURT, Principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03534349     History of Changes
Other Study ID Numbers: GO 16/740
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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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
lower limb flexibility
performance

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