Duchenne Muscular DystrophyNCT03589573
Effect of Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy and Muscle Strength, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Investigator researched that the effect of trunk and lower extremity muscle strength on hamstring flexibility in children with Duchenne Muscular Dystrophy. Read more about this study
- Who is it for?
- Ages 5 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Muscle Strength, Lower Extremity
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2017to 1 Jan 2018
- 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 18 years
- Men only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Getting a Duchenne Muscular Dystrophy diagnosis,
- Being in ambulatuar phases and independently climbing four stairs
- To be cooperate to physioterapist's directions
Who cannot join
- Having severe contracture in the lower extremity
- Having undergone surgery in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Trunk and Lower Extremity Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy
Investigator researched that the effect of trunk and lower extremity muscle strength on hamstring flexibility in children with Duchenne Muscular Dystrophy.
Read the detailed description
Thirty children were asessed by physical therapist. Nineteen children was Level 1 and eleven children was Level 2 according to Brooke Lower Extremity Functional Classification Scale.
- Keywords
- Duchenne Muscular Dystrophy, muscle strength, hamstring flexibility, back muscle, lower extremity
- 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 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.
Measured: 5 minute
Secondary outcomes (1)
trunk and lower extremity muscle strength test
Trunk and lower extremity muscle strength was assessed manual muscle strength and myometer. Any test was performed three times and best value was recorded.
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 start24 Mar 2017
- Primary completion25 Sep 2017
- Study completion1 Jan 2018
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lütfiye AKKURT, Hacettepe University
- Investigators
- Lütfiye Akkurt, Msc., Principal investigator, Hacettepe UniversityÖznur Yılmaz, Prof., Study director, Hacettepe Universityİpek Gürbüz, Assoc.Prof., Principal investigator, Hacettepe UniversityAyşe Karaduman, Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589573
- Sponsor's protocol ID
- GO 16/740-1
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 31 Jul 2018
- 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 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trunk and Lower Extremity Muscle Strength on Hamstring Flexibility in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT03589573
- Acronym / sponsor ID
- GO 16/740-1
- Keywords
- Duchenne Muscular Dystrophy, muscle strength, hamstring flexibility, back muscle, lower extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 1 Jan 2018 (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 researched that the effect of trunk and lower extremity muscle strength on hamstring flexibility in children with Duchenne Muscular Dystrophy.
Detailed description
Thirty children were asessed by physical therapist. Nineteen children was Level 1 and eleven children was Level 2 according to Brooke Lower Extremity Functional Classification Scale.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Getting a Duchenne Muscular Dystrophy diagnosis,
- Being in ambulatuar phases and independently climbing four stairs
- To be cooperate to physioterapist's directions
Key exclusion criteria (2 listed)
- Having severe contracture in the lower extremity
- Having undergone surgery in the past 6 months
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 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.
1 secondary outcome
trunk and lower extremity muscle strength test
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 31 Jul 2018.
- 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.
Lütfiye Akkurt, Msc. principal investigator
Hacettepe University
Öznur Yılmaz, Prof. study director
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 Muscle Strength, 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 3 inclusion and 2 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 31 Jul 2018. 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 31 Jul 2018.