NCT03589573

Brief Summary

Investigator researched that the effect of trunk and lower extremity muscle strength on hamstring flexibility 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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
6 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
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

July 5, 2018

Last Update Submit

July 27, 2018

Conditions

Keywords

Duchenne Muscular Dystrophymuscle strengthhamstring flexibilityback musclelower extremity

Outcome Measures

Primary Outcomes (1)

  • popliteal angle test

    The popliteal angle test was performed to assess hamstring flexibility. The popliteal angle was measured in a supine position and the hip flexed 90°, and fixed by first physical therapist. Opposite knee and hip were placed in extension position. Then, the child was asked to rise lower leg straight. The incomplete angle for full extension of the knee was the popliteal angle.

    5 minute

Secondary Outcomes (1)

  • trunk and lower extremity muscle strength test

    20 minute

Eligibility Criteria

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

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 was evaluated by Popliteal Angle Test. Muscle strenght was assessed with manuel muscle strength test and myometer. correlation between the flexibility of hamstrings and muscle strength tests were examined.

You may qualify if:

  • Getting a Duchenne Muscular Dystrophy diagnosis,
  • Being in ambulatuar phases and independently climbing four stairs
  • To be cooperate to physioterapist's directions

You may not qualify if:

  • Having severe contracture in the lower extremity
  • Having undergone surgery in the past 6 months

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

  • Lütfiye Akkurt, Msc.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Öznur Yılmaz, Prof.

    Hacettepe University

    STUDY DIRECTOR
  • İpek 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

July 5, 2018

First Posted

July 18, 2018

Study Start

March 24, 2017

Primary Completion

September 25, 2017

Study Completion

January 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations