Duchenne Muscular DystrophyNCT05436210
Postural and Anthropometric Properties of Foot and Ankle of Patients With DMD
An observational study of Duchenne Muscular Dystrophy and Ambulation Difficulty, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Progressive muscle weakness, joint contractures and body alignment disorders seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure of the patients. Read more about this study
- Who is it for?
- Ages 5 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Ambulation Difficulty, Posture Disorders in Children
- What is being tested?
- foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2022to 23 Nov 2022
- How long will I take part?
- 1 Day
- 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: Ambulated Duchenne Muscular Dystrophy patients aged of 5-18 years
Who may be able to join
- 1.5 to 18 years old 2. Not to have lost his ambulation 3. Agreeing to participate in the research voluntarily
Who cannot join
- Having serious mental and psychological problems,
- Having lost his ambulation
- Inability to cooperate adequately with the physiotherapist who made the evaluations,
- Any injury and/or surgery to the lower extremities in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Postural and Anthropometric Properties of Foot and Ankle on Physical Performance and Ambulation of Patients With Duchenne Muscular Dystrophy
Introduction: Progressive muscle weakness, joint contractures and body alignment disorders seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure of the patients.
Objective: The aim of this study is to examine the relationship between foot posture, performance and ambulation in patients with DMD.
Method: The patient with ambulatory DMD will be included in the study. The foot postures of the patients will be evaluated with the Foot Posture Index. Relationships between the Foot Posture Index and performance tests (6 minute walk test, timed performance tests (10m walking, Gower's, climb/descend 4 stair)) and the North Star Ambulation Evaluation, an ambulation evaluation, will be examined.
- Conditions
- Duchenne Muscular Dystrophy, Ambulation Difficulty, Posture Disorders in Children, Ambulation Disorder, Neurologic
- Being tested
- foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test
- Keywords
- Duchenne Muscular Dystrophy, foot posture, performance, ambulation
- Medical subject headings
- Muscular Dystrophy, Duchenne, Mobility Limitation, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk testOther
Patients will be evaluated only observationally without intervention by foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test
What is being measured
The primary outcome is the main question the study is designed to answer.
foot posture index - 6
The Foot Posture Index - 6 (FPI-6) was evaluated with each child standing and using the original protocol. FPI-6 values ranged from -2 to +2 for each of the six criteria and from -12 to +12 for the total score, indicative of position of each foot along the supinated to pronated continuum of foot posture.
Measured: 10 minutes
6 min walk test (6MWT)
Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.
Measured: 6 minutes
north star ambulation assessment
Patients' ambulation will be evaluated with the North Star Ambulation Assessment (NSAA). The NSAA consists of 17 items and evaluates ambulation with functional activities such as walking, getting up from a chair, going up and down stairs, and running. Each item is scored in the range of 0-2 points and the total score is in the range of 0-34. High score indicates better ambulation status
Measured: 10 minutes
timed performance test
Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start23 Jun 2022
- Primary completion20 Oct 2022
- Study completion23 Nov 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Suleyman Demirel University
- Responsible party
- Principal investigator, Güllü AYDIN YAĞCIOĞLU, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436210
- Sponsor's protocol ID
- GO 22/414
- Status last verified
- Jan 2023
- First submitted
- 23 Jun 2022
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postural and Anthropometric Properties of Foot and Ankle on Physical Performance and Ambulation of Patients With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05436210
- Acronym / sponsor ID
- GO 22/414
- Conditions
- Duchenne Muscular Dystrophy, Ambulation Difficulty, Posture Disorders in Children, Ambulation Disorder, Neurologic
- Keywords
- Duchenne Muscular Dystrophy, foot posture, performance, ambulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Suleyman Demirel University
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 29 Jun 2022 (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.
Introduction: Progressive muscle weakness, joint contractures and body alignment disorders seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure of the patients.
Objective: The aim of this study is to examine the relationship between foot posture, performance and ambulation in patients with DMD.
Method: The patient with ambulatory DMD will be included in the study. The foot postures of the patients will be evaluated with the Foot Posture Index. Relationships between the Foot Posture Index and performance tests (6 minute walk test, timed performance tests (10m walking, Gower's, climb/descend 4 stair)) and the North Star Ambulation Evaluation, an ambulation evaluation, will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 5 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Ambulated Duchenne Muscular Dystrophy patients aged of 5-18 years
Key inclusion criteria (1 listed)
- 1.5 to 18 years old 2. Not to have lost his ambulation 3. Agreeing to participate in the research voluntarily
Key exclusion criteria (4 listed)
- Having serious mental and psychological problems,
- Having lost his ambulation
- Inability to cooperate adequately with the physiotherapist who made the evaluations,
- Any injury and/or surgery to the lower extremities in the last 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk testPatients will be evaluated only observationally without intervention by foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test | Other | – |
Primary outcome
foot posture index - 6
Time frame: 10 minutes
The Foot Posture Index - 6 (FPI-6) was evaluated with each child standing and using the original protocol. FPI-6 values ranged from -2 to +2 for each of the six criteria and from -12 to +12 for the total score, indicative of position of each foot along the supinated to pronated continuum of foot posture.
6 min walk test (6MWT)
Time frame: 6 minutes
Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.
north star ambulation assessment
Time frame: 10 minutes
Patients' ambulation will be evaluated with the North Star Ambulation Assessment (NSAA). The NSAA consists of 17 items and evaluates ambulation with functional activities such as walking, getting up from a chair, going up and down stairs, and running. Each item is scored in the range of 0-2 points and the total score is in the range of 0-34. High score indicates better ambulation status
timed performance test
Time frame: ten minutes
Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.
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 4 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ambulation Difficulty, 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 1 inclusion and 4 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 4 Jan 2023. 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?
foot posture index - 6 (time frame: 10 minutes). The study lists 4 primary outcomes in all. 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 4 Jan 2023.