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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03589612
Other study ID # GO 16/740-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 8, 2018
Est. completion date January 24, 2019

Study information

Verified date September 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 24, 2019
Est. primary completion date January 24, 2019
Accepts healthy volunteers
Gender Male
Age group 5 Years to 14 Years
Eligibility 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.

Study Design


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 Popliteal Angle Test 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. 5 minute
Secondary 6 Minute Walk Test 6 Minute Walk Test was used to assess performance with children Duchenne MUscular Dystropy. 6 minute
Secondary North Star Ambulation Assessment 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. 20 minute
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