NCT03534349

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

May 10, 2018

Last Update Submit

May 22, 2018

Conditions

Duchenne Muscular DystrophyPerformanceFlexibility

Keywords

Duchenne Muscular Dystrophylower limb flexibilityperformance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Timed Performance Test

    3 minute

Eligibility Criteria

Age5 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children with ambule Duchenne Muscular Dystrophy

You may qualify if:

  • 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.

You may not qualify if:

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

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

  • Öznur Tunca Yılmaz, Prof.

    Hacettepe University

    STUDY DIRECTOR

  • İpek Alemdaroğlu Gürbüz, Assoc. Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

  • Ayşe Karaduman, Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

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

May 10, 2018

First Posted

May 23, 2018

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

TU(1)