Duchenne Muscular DystrophyNCT05575648
Dual Task in Duchenne Muscular Dystrophy
A study testing 10 meter walk test in people with Duchenne Muscular Dystrophy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effects of the dual-task performance of children with DMD with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship… Read more about this study
- Who is it for?
- Ages 6 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy
- What is being tested?
- 10 meter walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2022to 1 May 2023
- Phase
- Interventional
- 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 6 years and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having been diagnosed with DMD by a pediatric neurologist,
- Must be at least 6 years old and have the ability to walk 10 meters independently,
- Being able to cooperate with the instructions given by the physiotherapist,
- Not having undergone surgery in the last 6 months and not having any injuries,
Who cannot join
- Failure to cooperate with the physiotherapist who made the evaluations,
- Have had any injury and/or surgery in the last 6 months,
- Children without consent will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Dual Task Performance in Children With Duchenne Muscular Dystrophy
This study was planned to determine the effects of the dual-task performance of children with DMD with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship between parameters that may affect dual-task performance.
Read the detailed description
Children who are at least 6 years old and who can walk 10 meters independently, whose Duchenne's muscular dystrophy (DMD) diagnosis has been confirmed as a result of genetic testing, will be included in the study. To determine dual-task performance, the 10-meter Walk Test will be performed with additional motor and cognitive tasks. Functional level (Brooke Lower Extremity Functional Classification), ambulation level (North Star Ambulation Rating), muscular performance and functions (6 Minute Walk Test), balance (Pediatric Berg Balance Scale and four square step test), fear of falling (Fear of Falling Questionnaire), gait (Gait in DMD Assessment Scale, Gait Quality and Independence Classification Scale in DMD, and Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain (FES-DMD-GD)), cognitive level (Modified Mini-Mental State Test (MMDT)), independence and activity limitation (Pediatric Functional Independence Measure (WeeFIM) and ACTIVLIM), quality of life (The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0 Neuromuscular Module) will be evaluated.
- Conditions
- Duchenne Muscular Dystrophy
- Being tested
- 10 meter walk test
- Keywords
- Duchenne Muscular Dystrophy, Dual task, Balance, Gait
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 meter walk testOther
To assess the dual task performance of children 10 meter walk test will be used.
| Study group | Role | What they receive |
|---|---|---|
| Duchenne Muscular Dystrophy | Other | Children who have been diagnosed with Duchenne Muscular Dystrophy. Receives: Other: 10 meter walk test |
| Healthy Subjects | Active comparator | Children who have a normal motor and cognitive development. Receives: Other: 10 meter walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual task performance- 10 meter walk test
The time is measured after 10 meter walk completed
Measured: only baseline
Dual task performance- 10 meter walk test with cognitive task
The time is measured after 10 meter walk with a cognitive (memory and mental) task completed
Measured: only baseline
Dual task performance- 10 meter walk test with motor task
The time is measured after 10 meter walk with a motor task completed
Measured: only baseline
Secondary outcomes (14)
Functional level- Brooke Lower Extremity Functional Classification
It was developed using the classification method based on Vignos et al. to determine the functional status of the lower extremity. It consists of 10 different levels, ranging from Level 1 (walks independently and climbs stairs) to Level 10 (bound to bed).
Measured: only baseline
Ambulation level- North star ambulatory assessment
It consists of an item that allows the evaluation of activities that children frequently use in their daily lives, such as "standing up from a chair", "climbing steps", "stepping down", "standing up", "running". Scoring; 2 = the activity is done unassisted, normally, 1 = the activity is done unassisted but in a modified form, and 0 = the activity cannot be done independently. The total score ranges from 0-34. A higher score indicates better ambulation and motor function. It is a practical and valid reliable scale for children with DMD.
Measured: only baseline
Performance- 6 minutes walk test
The 6-minutes walk test (6 MWT), which is valid and reliable for DMD patients, will evaluate the walking function and physical capacity of children at the submaximal level. The distance the child walks for 6 minutes in a 25 m corridor will be recorded in meters. A physiotherapist will walk with the children during the test and track the time with a stopwatch. The 6 MWT is a simple test and considered an important outcome measure for children with DMD.
Measured: only baseline
Balance - Pediatric berg balance scale
It is a test that functionally evaluates balance and consists of 14 parts, including parameters such as standing up from sitting, standing, transfers, taking steps, and turning. Each section is scored between 0-4 and the highest score that can be obtained from the scale is 56. High scores indicate good balance performance.
Measured: only baseline
Balance - Four square step test
It is a valid and reliable test that has been used frequently in children in recent years to evaluate dynamic balance. Sticks, each 90 cm long, are placed on the floor to form 4 squares and the squares are numbered from 1 to 4. For the test to be completed successfully, the child must quickly move from one square to the next without touching the sticks. Performance is determined by measuring the test completion time in seconds. Shorter completion time means better dynamic balance.
Measured: only baseline
Fear of falling - Pediatric Fear of Falling Questionnaire
Its validity and reliability have been established in children with DMD. The test consists of 34 items that question children's fear of falling during different activities in daily life. It is scored as "0=Never", "1=Sometimes", "2=Always" and the highest possible score is 68. Higher scores indicate greater fear of falling.
Measured: only baseline
Fall frequency
How many times children have fallen in the last week (fall frequency) will be recorded.
Measured: only baseline
Gait - Gait Evaluation Scale in Duchenne Muscular Dystrpohy
It consists of 10 items that examine the kinetic/kinematic condition of the foot, knee, hip, lumbar region, trunk, arm and head, support surface, walking speed and stride length, and each item is scored between 0 (worst) - 2 (best).
Measured: only baseline
Gait - Gait Classification Scale in Duchenne Muscular Dystrpohy
It classifies gait with 5 levels, from Level 1 (Patient walks without compensation) to Level 5 (Patient cannot walk).
Measured: only baseline
Gait - Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain
It allows the compensatory movements of ambulatory children to be examined in detail through observation and provides a kinesiological analysis of gait by detecting and scoring compensatory movements. The scale consists of 3 parts: stance phase, swing phase and general compensatory movements. The points that can be obtained from the stance phase are between 0-23, the points that can be obtained from the swing phase are between 0-11, and the points that can be obtained from the general compensatory movements are between 0-13. Lower scores indicate good performance.
Measured: only baseline
Cognitive level - Modified Mini Mental Test
The Mini Mental Test developed for adults was adapted to the pediatric population by making minor modifications. Test; It evaluates verbal responses including attention, orientation, memory and language skills, ability to obey verbal and written orders, write spontaneous sentences, and copy a complex drawing. The highest score that can be obtained from this test is 37, the lowest score is 0. The total score reaches a plateau at approximately 9-10 years of age and corresponds to the scores of healthy adults. Values below 27 points out of a total of 37 points in children over the age of 10 are indicative of mental retardation or dementia.
Measured: only baseline
Activity of daily living - The Functional Independence Measure for Children (WeeFIM)
It consists of 6 sections and 18 items covering self-care, sphincter control, transfers, locomotion, communication, social and cognitive domains. Each item is scored between 7 (completely independent) and 1 (fully assisted) and the total score is determined as a minimum of 18 (fully dependent) and a maximum of 126 (completely independent).
Measured: only baseline
Activity of daily living - ACTIVLIM
It is a scale developed to evaluate activity limitations in all neuromuscular diseases, including adult and childhood, and has Turkish validity and reliability. The scale includes 22 items that evaluate activities of daily living that require the use of the upper and lower extremities. Scoring; "0 = cannot do the activity", "1 = has difficulty in doing the activity", "2 = can do the activity easily" and according to this score, the patients are asked to describe their level of difficulty in performing each activity. The highest score that can be obtained from the test is 36, and higher scores indicate less activity limitations.
Measured: only baseline
Quality of life - The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0
This scale, which was found to be valid and reliable to evaluate the quality of life of children with neuromuscular disease, consists of 3 parts containing a total of 25 items. The first part contains 17 items about the disease, the second part contains 3 items about communication skills, and the third part contains 5 items about the family's financial resources and social support systems. The scale consists of a child personal report and a parent report for children aged 5-18, while only a parent report for children aged 2-4. Each item is scored between 4 (always a problem) - 0 (never a problem). Scoring is converted to 0=100, 1=75, 2=50, 3=25, 4=0. A higher score on the scale indicates a better health-related quality of life.
Measured: only baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start6 Sep 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Kayabınar, Hacettepe University
- Investigators
- Oznur YILMAZ, Prof, Study director, Hacetteoe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575648
- Sponsor's protocol ID
- 2022/13-45
- Status last verified
- Feb 2024
- First submitted
- 8 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dual Task Performance in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05575648
- Acronym / sponsor ID
- 2022/13-45
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- Duchenne Muscular Dystrophy, Dual task, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 12 Oct 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.
This study was planned to determine the effects of the dual-task performance of children with DMD with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship between parameters that may affect dual-task performance.
Detailed description
Children who are at least 6 years old and who can walk 10 meters independently, whose Duchenne's muscular dystrophy (DMD) diagnosis has been confirmed as a result of genetic testing, will be included in the study. To determine dual-task performance, the 10-meter Walk Test will be performed with additional motor and cognitive tasks. Functional level (Brooke Lower Extremity Functional Classification), ambulation level (North Star Ambulation Rating), muscular performance and functions (6 Minute Walk Test), balance (Pediatric Berg Balance Scale and four square step test), fear of falling (Fear of Falling Questionnaire), gait (Gait in DMD Assessment Scale, Gait Quality and Independence Classification Scale in DMD, and Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain (FES-DMD-GD)), cognitive level (Modified Mini-Mental State Test (MMDT)), independence and activity limitation (Pediatric Functional Independence Measure (WeeFIM) and ACTIVLIM), quality of life (The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0 Neuromuscular Module) will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duchenne Muscular Dystrophy | Other | Other: 10 meter walk testChildren who have been diagnosed with Duchenne Muscular Dystrophy. |
| Healthy Subjects | Active comparator | Other: 10 meter walk testChildren who have a normal motor and cognitive development. |
Who may qualify
- Ages
- 6 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having been diagnosed with DMD by a pediatric neurologist,
- Must be at least 6 years old and have the ability to walk 10 meters independently,
- Being able to cooperate with the instructions given by the physiotherapist,
- Not having undergone surgery in the last 6 months and not having any injuries,
Key exclusion criteria (3 listed)
- Failure to cooperate with the physiotherapist who made the evaluations,
- Have had any injury and/or surgery in the last 6 months,
- Children without consent will not be included.
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 |
|---|---|---|
| 10 meter walk testTo assess the dual task performance of children 10 meter walk test will be used. | Other | Duchenne Muscular Dystrophy, Healthy Subjects |
Primary outcome
Dual task performance- 10 meter walk test
Time frame: only baseline
The time is measured after 10 meter walk completed
Dual task performance- 10 meter walk test with cognitive task
Time frame: only baseline
The time is measured after 10 meter walk with a cognitive (memory and mental) task completed
Dual task performance- 10 meter walk test with motor task
Time frame: only baseline
The time is measured after 10 meter walk with a motor task completed
14 secondary outcomes
Functional level- Brooke Lower Extremity Functional Classification
Time frame: only baseline
Ambulation level- North star ambulatory assessment
Time frame: only baseline
Performance- 6 minutes walk test
Time frame: only baseline
Balance - Pediatric berg balance scale
Time frame: only baseline
Balance - Four square step test
Time frame: only baseline
Fear of falling - Pediatric Fear of Falling Questionnaire
Time frame: only baseline
Fall frequency
Time frame: only baseline
Gait - Gait Evaluation Scale in Duchenne Muscular Dystrpohy
Time frame: only baseline
Gait - Gait Classification Scale in Duchenne Muscular Dystrpohy
Time frame: only baseline
Gait - Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain
Time frame: only baseline
Cognitive level - Modified Mini Mental Test
Time frame: only baseline
Activity of daily living - The Functional Independence Measure for Children (WeeFIM)
Time frame: only baseline
Activity of daily living - ACTIVLIM
Time frame: only baseline
Quality of life - The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0
Time frame: only baseline
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 28 Feb 2024.
- 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.
Oznur YILMAZ, Prof study director
Hacetteoe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 meter walk test in people with Duchenne Muscular Dystrophy, 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 4 inclusion and 3 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 28 Feb 2024. 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?
Dual task performance- 10 meter walk test (time frame: only baseline). The study lists 3 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 28 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.