- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949475
Dual Task and Upper Extremity Performance in Children With Myelomeningocele
Comparison of Dual Task and Upper Extremity Performance in Children With Myelomeningocele and Typically Developing Peers
Study Overview
Status
Conditions
Intervention / Treatment
- 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)
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bolu
-
Merkez, Bolu, Turkey (Türkiye), 14030
- Bolu Abant İzzet Baysal Üniversity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- 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:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Meningomyelocele Group
Individuals between the ages of 7-18 years with a diagnosis of meningomyelocele
|
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.
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.
Box Block Test-for the cognitive task assessment, the individual will be asked to count animal names while performing the 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
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.
9 Hole Peg Test-for motor task assessment, the individual will be asked to bend and unbend the other elbow while performing the 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.
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.
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.
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
|
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.
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.
Box Block Test-for the cognitive task assessment, the individual will be asked to count animal names while performing the 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
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.
9 Hole Peg Test-for motor task assessment, the individual will be asked to bend and unbend the other elbow while performing the 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dual Task (Box and Block Test-Motor Task)
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
|
Dual Task (Box and Block Test-Kognitif Task)
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
|
Dual Task (Nine Hole Peg Test-Motor Task)
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
|
Dual Task (Nine Hole Peg Test-Kognitif Task)
Time Frame: through study completion, an average of 1 year
|
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
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Single Task (Box and Block Test)
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
|
Single Task (Nine Hole Peg Test)
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
|
ABILHAND-Kids
Time Frame: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sezen Tezcan, Ph.D, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-ST-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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