NCT03589612

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

July 5, 2018

Last Update Submit

September 27, 2019

Conditions

Duchenne Muscular DystrophyPerformanceFlexibility

Keywords

Duchenne Muscular Dystrophyperformancehamstring flexibilityregression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 6 Minute Walk Test

    6 minute

  • North Star Ambulation Assessment

    20 minute

Eligibility Criteria

Age5 Years - 14 Years
Sexmale
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.

You may qualify if:

  • 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,

You may not qualify if:

  • Children who fail to meet these criteria study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Oznur Yılmaz

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 18, 2018

Study Start

March 8, 2018

Primary Completion

January 24, 2019

Study Completion

January 24, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)