Duchenne Muscular DystrophyNCT03534349
Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance
An observational study of Duchenne Muscular Dystrophy and Performance, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy. Read more about this study
- Who is it for?
- Ages 5 years and older, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Performance, Flexibility
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Dec 2017
- 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 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children with ambule Duchenne Muscular Dystrophy
Who may be able to join
- 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.
Who cannot join
- Children who did not provide these criteria and did not will to participate the study were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy.
Read the detailed description
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, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. Popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. Functional performance was assessed with 6 Minute Walk Test (6 MWT) and Timed Performance Tests. The correlation between the flexibility of lower limb muscles' and performance tests were examined.
- Conditions
- Duchenne Muscular Dystrophy, Performance, Flexibility
- Keywords
- Duchenne Muscular Dystrophy, lower limb flexibility, performance
- Medical subject headings
- Muscular Dystrophy, Duchenne
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 Minute
Secondary outcomes (1)
Timed Performance Test
Timed performance tests such as 10 m walk, Gower's (from supine position to stand up), ascending/descending 4 steps were also performed. During these tests, the child's performance was recorded in seconds.
Measured: 3 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study startJan 2017
- Primary completionJun 2017
- Study completionDec 2017
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.
- 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
- Öznur Tunca Yılmaz, Prof., Study director, Hacettepe Universityİpek Alemdaroğlu Gürbüz, Assoc. Prof., Principal investigator, Hacettepe UniversityAyşe Karaduman, Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534349
- Sponsor's protocol ID
- GO 16/740
- Status last verified
- May 2018
- First submitted
- 10 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb Flexibility in Duchenne Muscular Dystrophy: Effects on Functional Performance
- ClinicalTrials.gov ID
- NCT03534349
- Acronym / sponsor ID
- GO 16/740
- Conditions
- Duchenne Muscular Dystrophy, Performance, Flexibility
- Keywords
- Duchenne Muscular Dystrophy, lower limb flexibility, performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 May 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.
The investigator investigated the effect of lower limb flexibility on functional performance of children with Duchenne Muscular Dystrophy.
Detailed description
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, hip flexors, tensor fascia latae, and gastrocnemius muscles were evaluated in dominant lower limb. Popliteal angle test, hip flexor flexibility test, tensor fascia latae flexibility test and gastrocnemius flexibility test were used for flexibility asssessments. Functional performance was assessed with 6 Minute Walk Test (6 MWT) and Timed Performance Tests. The correlation between the flexibility of lower limb muscles' and performance tests were examined.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 5 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with ambule Duchenne Muscular Dystrophy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Children who did not provide these criteria and did not will to participate the study were excluded.
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
6 Minute Walk Test
Time frame: 6 Minute
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
1 secondary outcome
Timed Performance Test
Time frame: 3 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 24 May 2018.
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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.
Öznur Tunca Yılmaz, Prof. study director
Hacettepe University
İpek Alemdaroğlu Gürbüz, Assoc. Prof. principal investigator
Hacettepe University
Ayşe Karaduman, 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 24 May 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?
6 Minute Walk Test (time frame: 6 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 24 May 2018.