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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05575648
Study groupRoleWhat they receive
Duchenne Muscular DystrophyOtherChildren who have been diagnosed with Duchenne Muscular Dystrophy.
Receives: Other: 10 meter walk test
Healthy SubjectsActive comparatorChildren 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.

  1. Dual task performance- 10 meter walk test

    The time is measured after 10 meter walk completed

    Measured: only baseline

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Fall frequency

    How many times children have fallen in the last week (fall frequency) will be recorded.

    Measured: only baseline

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted12 Oct 2022
  2. Study start6 Sep 2022
  3. Primary completion1 Apr 2023
  4. Study completion1 May 2023

Resources

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)
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

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.

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