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MeningomyeloceleNCT06949475

Dual Task and Upper Extremity Performance in Children With Myelomeningocele

An observational study of Meningomyelocele, run by Abant Izzet Baysal 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

Myelomeningocele is a neural tube defect caused by the failure of the neural tube to close in the caudal part. The exposed spinal cord in myelomeningocele usually causes neural damage. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Meningomyelocele
What is being tested?
Single Task (Box and Block Test), Single Task (Nine Hole Peg Test) and Dual Task (Box and Block Test-Kognitif Task)
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 May 2025to 19 Dec 2025
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 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Children diagnosed with meningomyelocele and typically developing peers who agreed to participate in the study and met the inclusion criteria.

Who may be able to join

  • For children with meningomyelocele
  • To be between the ages of 7-18
  • To have been diagnosed with meningomyelocele
  • To have scored 27 points or more on the modified mini mental test
  • For children with typical developing
  • Being between the ages of 7-18 years
Show all 9Show fewer
  • Having no typically developing musculoskeletal problems and volunteering to participate in the study
  • Not having a chronic neurological, cardiovascular or orthopedic disease
  • Having a score of 27 or above on the modified mini mental test

Who cannot join

  • For children with meningomyelocele
  • Not agreeing to participate in the study,
  • Having undergone surgery or Botolunium toxin administration within the last six months
  • Having suffered a fracture of the upper extremity within the last six months
  • For children with typical developing
  • Having severe visual or hearing impairment
  • Having attention problems to the extent that they cannot understand the assessment instructions
  • Having a musculoskeletal, cardiovascular, pulmonary, metabolic or other disease severe enough to prevent participation in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bolu abant Izzet Baysal University

    Merkez, Bolu, 14030

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Dual Task and Upper Extremity Performance in Children With Myelomeningocele and Typically Developing Peers

Myelomeningocele is a neural tube defect caused by the failure of the neural tube to close in the caudal part. The exposed spinal cord in myelomeningocele usually causes neural damage. Children with myelomeningocele have varying degrees of disability depending on the level of lesion and the presence of CNS-related anomalies. Lower limb weakness, sensory loss or deformity, and impaired bowel and bladder function are common disabilities that need to be managed. Performing multiple tasks simultaneously is a necessity in the daily lives of both adults and children. Although the majority of children with myelomeningocele lack the ability to ambulate and spend most of the day sitting, they have to perform dual tasking while performing activities of daily living as in all children. In the literature, dual task performance has been evaluated in many studies in adult individuals with diseases such as Multiple sclerosis, Stroke, Parkinson's, etc. However, there are few studies in the pediatric population in the literature. Most of the studies conducted in children include children with cerebral palsy and there are almost no studies in children with myelomeningocele. Therefore, the aim of this study was to compare dual task and upper extremity performance in children with myelomeningocele to typically developing peers.

Read the detailed description

Within the scope of the study, socio-demographic information of the individuals will be recorded first. Afterwards, the Box Block Test and 9-hole peg test will be performed for single task assessment. The children will be seated on a chair with back support and before the test starts, all the details about the application will be explained to the person and the person will be given the opportunity to make a trial and if there are mistakes, they will be warned and then the actual evaluation will be started.

After the single task evaluation, the dual task performance will be evaluated. When testing dual task performance, participants will be asked to perform both tasks without prioritizing them and to do their best. However, they will also be instructed not to pause for reflection. A rest interval of at least 3 minutes will be given between all tests. Dual task complexity of the given upper limb functions will be measured by calculating the 'dual task effect' for both tasks. The formula used to calculate the dual task effect is as follows: Dual Task Effect=(Dual Task-Single Task/Single Task)x 100. If the result is positive, it is assumed that there is an improvement in the dual task conditions; if it is negative, it is assumed that there is a decrease in the dual task conditions. The results of children's performance will be recorded in the relevant table in the demographic data form

Being tested
Single Task (Box and Block Test), Single Task (Nine Hole Peg Test), Dual Task (Box and Block Test-Kognitif Task), Dual Task (Nine Hole Peg Test-Kognitif Task), Dual Task (Box and Block Test-Motor Task)
Keywords
Meningomyelocele, Dual task, Upper extremity performance
Medical subject headings
Meningomyelocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single Task (Box and Block Test)Diagnostic test

    The test requires a wooden box divided into two compartments and 150 blocks (2.5 cm tall). When administering the test, the evaluator should be aware of whether the child's fingertips move from one compartment to the other. The number of blocks passed from one side of the box to the other in one minute determines the level of the skill. It is done separately for right and left hand. The number of cubes thrown in 1 minute gives the score.

  • Single Task (Nine Hole Peg Test)Diagnostic test

    The 9-hole peg test is a standardized test that measures fine dexterity against time. It is simple to administer and is a valid and reliable method of assessment. Both hands are tested in the assessment. The child is first asked to place 9 sticks of 3.2 cm in length into the holes on the platform as quickly as possible with the dominant hand and the time from the start command until the last stick is placed is recorded. Then, with the same hand, he/she is asked to pick up the sticks in order and the time to remove all the sticks is recorded in seconds. The same procedure is repeated with the other hand.

  • Dual Task (Box and Block Test-Kognitif Task)Diagnostic test

    Box Block Test-for the cognitive task assessment, the individual will be asked to count animal names while performing the test.

  • Dual Task (Nine Hole Peg Test-Kognitif Task)Diagnostic test

    9 Hole Peg Test-for the cognitive task assessment, the individual will be asked to count backwards from 20 one by one while performing the test

  • Dual Task (Box and Block Test-Motor Task)Diagnostic test

    For the Box Block Test-motor task assessment, the individual will be asked to keep a rhythm by tapping the table with the fingers on the other side while performing the test. The number of blocks passed from one side to the other side of the box divided into two in one minute will be determined and recorded.

  • Dual Task (Nine Hole Peg Test-Motor Task)Diagnostic test

    9 Hole Peg Test-for motor task assessment, the individual will be asked to bend and unbend the other elbow while performing the test.

  • ABILHAND-KidsDiagnostic test

    The Abilhand Kids Hand-Related Ability Scale will be used to assess the use of upper extremities in Activities of Daily Living (ADL). The scale includes 21 sub-items. Sub-items are scored as 0; cannot do, 1; has difficulty in doing and 2; can easily do. The questions are usually answered by the parent, but can also be answered by the child if the child is old enough and cognitive level is appropriate.

  • Functional Mobility Scale (FMS)Diagnostic test

    The child's walking ability is assessed at 3 different distances (5 meters (home), 50 meters (school), 500 meters (community)). The assessment at all three distances is graded on a scale of 1-6, with wheelchair mobilization 1 and independent ambulation 6. It is indicated as (C) if the distance can be covered by crawling and (N) if the distance cannot be covered by any other means. The assessment is done through an interview with the family. The child is not observed.

  • Myelomeningocele Functional Classification System (MMFC)Diagnostic test

    The Myelomeningocele Functional Classification System (MMFC) is a 4-level system that classifies individuals with myelomeningocele according to their functional capacity. The functional status of children in Level 1 is more inadequate than in other levels. Functional status improves as the level increases.

  • Modified Mini Mental Test (MMMT)Diagnostic test

    The Modified Mini Mental Test (MMMT) is used to screen for cognitive dysfunctions in children, to assess the severity of impairments and to determine changes over time. It has been reported that the test is a suitable tool for examining cognitive functions in children from the age of 4 and can be easily included in general neurological examinations of children. The test, which takes 5 to 10 minutes to administer, assesses 5 cognitive domains, including orientation, memory, concentration, language function and measures of structural ability. The total score in this test reaches a plateau at approximately 9-10 years of age. In children over 10 years of age, scores below 27 out of a total of 35 points are indicative of mental retardation.

Study groups in NCT06949475
Study groupRoleWhat they receive
Meningomyelocele GroupIndividuals between the ages of 7-18 years with a diagnosis of meningomyelocele
Receives: Diagnostic Test: Single Task (Box and Block Test); Diagnostic Test: Single Task (Nine Hole Peg Test); Diagnostic Test: Dual Task (Box and Block Test-Kognitif Task); Diagnostic Test: Dual Task (Nine Hole Peg Test-Kognitif Task); Diagnostic Test: Dual Task (Box and Block Test-Motor Task); Diagnostic Test: Dual Task (Nine Hole Peg Test-Motor Task); Diagnostic Test: ABILHAND-Kids; Diagnostic Test: Functional Mobility Scale (FMS); Diagnostic Test: Myelomeningocele Functional Classification System (MMFC); Diagnostic Test: Modified Mini Mental Test (MMMT)
Typical Developing GroupTypically developing individuals between the ages of 7-18, who do not have any musculoskeletal system problems and who volunteer to participate in the study, who do not have a chronic neurological, cardiovascular or orthopedic disease
Receives: Diagnostic Test: Single Task (Box and Block Test); Diagnostic Test: Single Task (Nine Hole Peg Test); Diagnostic Test: Dual Task (Box and Block Test-Kognitif Task); Diagnostic Test: Dual Task (Nine Hole Peg Test-Kognitif Task); Diagnostic Test: Dual Task (Box and Block Test-Motor Task); Diagnostic Test: Dual Task (Nine Hole Peg Test-Motor Task); Diagnostic Test: ABILHAND-Kids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dual Task (Box and Block Test-Motor Task)

    The test requires a wooden box divided into two compartments and 150 blocks (2.5 cm tall). When administering the test, the evaluator should be aware of whether the child's fingertips move from one compartment to the other. The number of blocks passed from one side of the box to the other in one minute determines the level of the skill. It is done separately for right and left hand. The number of cubes thrown in 1 minute gives the score. For the Box Block Test-motor task assessment, the individual will be asked to keep a rhythm by tapping the table with the fingers on the other side while performing the test. The number of blocks passed from one side to the other side of the box divided into two in one minute will be determined and recorded.

    Measured: through study completion, an average of 1 year

  2. Dual Task (Box and Block Test-Kognitif Task)

    The test requires a wooden box divided into two compartments and 150 blocks (2.5 cm tall). When administering the test, the evaluator should be aware of whether the child's fingertips move from one compartment to the other. The number of blocks passed from one side of the box to the other in one minute determines the level of the skill. It is done separately for right and left hand. The number of cubes thrown in 1 minute gives the score. Box Block Test-for the cognitive task assessment, the individual will be asked to count animal names while performing the test.

    Measured: through study completion, an average of 1 year

  3. Dual Task (Nine Hole Peg Test-Motor Task)

    The Nine Hole Peg test is a standardized test that measures fine dexterity against time. It is simple to administer and is a valid and reliable method of assessment. Both hands are tested in the assessment. The child is first asked to place 9 sticks of 3.2 cm in length into the holes on the platform as quickly as possible with the dominant hand and the time from the start command until the last stick is placed is recorded. Then, with the same hand, he/she is asked to pick up the sticks in order and the time to remove all the sticks is recorded in seconds. The same procedure is repeated with the other hand. 9 Hole Peg Test-for motor task assessment, the individual will be asked to bend and unbend the other elbow while performing the test.

    Measured: through study completion, an average of 1 year

  4. Dual Task (Nine Hole Peg Test-Kognitif Task)

    The Nine Hole Peg test is a standardized test that measures fine dexterity against time. It is simple to administer and is a valid and reliable method of assessment. Both hands are tested in the assessment. The child is first asked to place 9 sticks of 3.2 cm in length into the holes on the platform as quickly as possible with the dominant hand and the time from the start command until the last stick is placed is recorded. Then, with the same hand, he/she is asked to pick up the sticks in order and the time to remove all the sticks is recorded in seconds. The same procedure is repeated with the other hand. 9 Hole Peg Test-for the cognitive task assessment, the individual will be asked to count backwards from 20 one by one while performing the test

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)
  1. Single Task (Box and Block Test)

    The test requires a wooden box divided into two compartments and 150 blocks (2.5 cm tall). When administering the test, the evaluator should be aware of whether the child's fingertips move from one compartment to the other. The number of blocks passed from one side of the box to the other in one minute determines the level of the skill. It is done separately for right and left hand. The number of cubes thrown in 1 minute gives the score.

    Measured: through study completion, an average of 1 year

  2. Single Task (Nine Hole Peg Test)

    The Nine Hole Peg test is a standardized test that measures fine dexterity against time. It is simple to administer and is a valid and reliable method of assessment. Both hands are tested in the assessment. The child is first asked to place 9 sticks of 3.2 cm in length into the holes on the platform as quickly as possible with the dominant hand and the time from the start command until the last stick is placed is recorded. Then, with the same hand, he/she is asked to pick up the sticks in order and the time to remove all the sticks is recorded in seconds. The same procedure is repeated with the other hand.

    Measured: through study completion, an average of 1 year

  3. ABILHAND-Kids

    The Abilhand Kids Hand-Related Ability Scale will be used to assess the use of upper extremities in Activities of Daily Living (ADL). The scale includes 21 sub-items. Sub-items are scored as 0; cannot do, 1; has difficulty in doing and 2; can easily do. The questions are usually answered by the parent, but can also be answered by the child if the child is old enough and cognitive level is appropriate.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start26 May 2025
  3. Primary completion1 Dec 2025
  4. Study completion19 Dec 2025

Resources

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
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949475
Sponsor's protocol ID
AIBU-FTR-ST-04
Status last verified
Dec 2025
First submitted
22 Apr 2025
Last updated
26 Dec 2025
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?

An observational study of Meningomyelocele, run by Abant Izzet Baysal 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 9 inclusion and 8 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 26 Dec 2025. 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 (Box and Block Test-Motor Task) (time frame: through study completion, an average of 1 year). 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 26 Dec 2025.

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