NCT06949475

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

April 22, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

MeningomyeloceleDual taskUpper extremity performance

Outcome Measures

Primary Outcomes (4)

  • 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.

    through study completion, an average of 1 year

  • 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.

    through study completion, an average of 1 year

  • 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.

    through study completion, an average of 1 year

  • 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

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Single Task (Box and Block Test)

    through study completion, an average of 1 year

  • Single Task (Nine Hole Peg Test)

    through study completion, an average of 1 year

  • ABILHAND-Kids

    through study completion, an average of 1 year

Study Arms (2)

Meningomyelocele Group

Individuals between the ages of 7-18 years with a diagnosis of meningomyelocele

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-KidsDiagnostic Test: Functional Mobility Scale (FMS)Diagnostic Test: Myelomeningocele Functional Classification System (MMFC)Diagnostic Test: Modified Mini Mental Test (MMMT)

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

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

Interventions

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.

Meningomyelocele GroupTypical Developing Group
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.

Meningomyelocele GroupTypical Developing Group

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.

Meningomyelocele GroupTypical Developing Group

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

Meningomyelocele GroupTypical Developing Group

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

Meningomyelocele GroupTypical Developing Group

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.

Meningomyelocele GroupTypical Developing Group

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

Meningomyelocele GroupTypical Developing Group

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.

Meningomyelocele Group

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.

Meningomyelocele Group

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.

Meningomyelocele Group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu abant Izzet Baysal University

Merkez, Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sezen Tezcan, Ph.D

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

May 26, 2025

Primary Completion

December 1, 2025

Study Completion

December 19, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations