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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03534349
Other study ID # GO 16/740
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date December 2017

Study information

Verified date May 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Male
Age group 5 Years and older
Eligibility 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.

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 6 Minute Walk Test 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 6 Minute
Secondary Timed Performance Test 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. 3 minute
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