Dual Task and Upper Extremity Performance in Children With Myelomeningocele
NCT ID: NCT06949475
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2025-05-26
2025-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Meningomyelocele Group
Individuals between the ages of 7-18 years with a diagnosis of meningomyelocele
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.
Single Task (Nine Hole Peg 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)
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)
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)
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)
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-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.
Functional Mobility Scale (FMS)
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)
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)
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.
Typical Developing Group
Typically 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
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.
Single Task (Nine Hole Peg 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)
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)
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)
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)
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-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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Single Task (Nine Hole Peg 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)
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)
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)
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)
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-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.
Functional Mobility Scale (FMS)
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)
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)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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.
7 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abant Izzet Baysal University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sezen Tezcan, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Abant Izzet Baysal University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bolu abant Izzet Baysal University
Merkez, Bolu, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIBU-FTR-ST-04
Identifier Type: -
Identifier Source: org_study_id