Duchenne Muscular DystrophyNCT03589612
Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy and Performance, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy. Read more about this study
- Who is it for?
- Ages 5 to 14 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Performance, Flexibility
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2018to 24 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- Men only
- Child
Study population: Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.
Who may be able to join
- 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,
Who cannot join
- Children who fail to meet these criteria study.
Trial locations and contacts
1 site in 1 country.
About this study
Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.
Read the detailed 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.
- Conditions
- Duchenne Muscular Dystrophy, Performance, Flexibility
- Keywords
- Duchenne Muscular Dystrophy, performance, hamstring flexibility, regression
- Medical subject headings
- Muscular Dystrophy, Duchenne
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minute
Secondary outcomes (2)
6 Minute Walk Test
6 Minute Walk Test was used to assess performance with children Duchenne MUscular Dystropy.
Measured: 6 minute
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.
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start8 Mar 2018
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lütfiye AKKURT, PT, Hacettepe University
- Investigators
- Güllü Aydın, Msc., Principal investigator, Hacettepe UniversityNuman Bulut, Msc, Principal investigator, Hacettepe Universityİpek Gürbüz, Assoc.Prof., Principal investigator, Hacettepe UniversityAyşe Karaduman, Prof., Principal investigator, Hacettepe UniversityOznur Yılmaz, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589612
- Sponsor's protocol ID
- GO 16/740-2
- Status last verified
- Sep 2019
- First submitted
- 5 Jul 2018
- Last updated
- 30 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03589612
- Acronym / sponsor ID
- GO 16/740-2
- Conditions
- Duchenne Muscular Dystrophy, Performance, Flexibility
- Keywords
- Duchenne Muscular Dystrophy, performance, hamstring flexibility, regression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 14 years
- Sex
- Male only
- Age groups
- Child
- Study population
- Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (1 listed)
- Children who fail to meet these criteria study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Popliteal Angle Test
Time frame: 5 minute
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.
2 secondary outcomes
6 Minute Walk Test
Time frame: 6 minute
North Star Ambulation Assessment
Time frame: 20 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Güllü Aydın, Msc. principal investigator
Hacettepe University
Numan Bulut, Msc principal investigator
Hacettepe University
İpek Gürbüz, Assoc.Prof. principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy and Performance, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Popliteal Angle Test (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.