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Spina BifidaNCT05318677

Sensory and Motor Proficiency For Children With Spina Bifida

An observational study of Spina Bifida and Sensory Disorder, run by Pamukkale University.

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

Spina bifida is one of the neural tube defects that cause neuromuscular dysfunction. Spina bifida is a disease accompanied by motor paralysis, musculoskeletal problems, Arnold-Chiari malformation, osteoporosis, hydrocephalus, upper limb coordination disorder. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Spina Bifida, Sensory Disorder, Motor Disorders
How many people
35 participants
Where
No sites listed yet
Study dates
Jan 2010to Dec 2010
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 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study.

Who may be able to join

None listed.

Who cannot join

  • Children who had a second illness and could not be contacted were not included in the study

About this study

Official title: The Relationship Between Sensory and Motor Proficiency For Children With Spina Bifida

Spina bifida is one of the neural tube defects that cause neuromuscular dysfunction. Spina bifida is a disease accompanied by motor paralysis, musculoskeletal problems, Arnold-Chiari malformation, osteoporosis, hydrocephalus, upper limb coordination disorder. The affected upper extremity functionality and hand skills are very important for independence in daily living activities.

There are some studies in the literature showing that upper extremity motor function is affected in patients with spina bifida. However, no study was found in which the upper extremity was investigated in terms of sensory and motor proficiency.The social and professional aspects of the upper extremity are of great importance.Therefore, our study aims to investigate the effects of upper extremity sensory and motor proficiency in patients with spina bifida

Read the detailed description

This study aims to examine the relationship between hand skills and upper extremity functional level patients with spina bifida. Fifteen patients with spina bifida and 20 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children.

Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.

All sensory evaluations; In a quiet, bright, warm room with only the physiotherapist and the subject, the evaluation was made while the subject was sitting in a chair with back support.

  • Stereognosis: For the evaluation of stereognosis, the subject was asked to recognize the materials placed in his hand by using a pen, paper, clip, cotton, and coin while his visual field was closed. Both dominant and nondominant extremities were evaluated.
  • Graphesthesia: When the visual field is closed, square, triangle, circle, and cross signs drawn on the palms of the subjects were asked to know these shapes.
  • Finger identification: The patient's fingers were numbered and the patient was asked to know which finger was touched by touching his finger while his visual field was closed, verbally or by showing.
  • Kinesthetic sense of hands: A total of 9 evaluations were made, the first of which was a trial, while the patient's visual field was closed. The evaluation was made for both dominant and nondominant extremities. The evaluation was made with both eyes open and closed.8 Evaluation under the title of visual and kinesthetic kinesthesia was scored between 0-3.
  • The motor proficiency and ability level of the cases were evaluated with the Bruininks-Oseretsky Test, which is used to evaluate the motor abilities of children aged 4.5-14.5 years in pediatric rehabilitation. The test consists of a total of 46 tests, 8 of which are subtests. Subtests to be applied to the patients in the study: Drawing lines through the path and folding paper tests were performed for the fine motor precision test.

Copying a square and copying star tests were applied for fine motor integration.

Transferring coins has been applied for manual dexterity. The case took the coin with the dominant hand and puts it in the box with the non-dominant hand. The number of coins left in the well in 15 seconds is calculated. The case was given 2 attempts.For upper extremity coordination, the tests of dropping and catching the ball with both hands and dribbling the ball with alternating hands were applied. For the test of dropping and catching the ball with both hands, the subject was given a tennis ball and asked to catch the ball by throwing it on the ground with both hands. A trial was allowed before starting the test.

Keywords
spina bifida, upper extremity function, sense, motor function
Medical subject headings
Spinal Dysraphism, Sensation Disorders, Motor Disorders

What participants receive

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

Study groups in NCT05318677
Study groupRoleWhat they receive
1Fifteen patients with spina bifida aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.
220 healthy subjects as a control group aged 8-12 years living in Denizli province were included in the study. The participants were informed about the research and read the voluntary consent form, and written consent was obtained from their families since the participants were children. Children with literate, well cooperated, aged 8-12 years, and attending any primary school were included in the study. Children who had a second illness and could not be contacted were not included in the study. Non-dominant and dominant extremities of all cases were evaluated by the tests. It was recorded socio-demographic data were questioned. Sensory evaluation forms for upper extremities, Bruininks-Oseretsky motor proficiency, and ability tests were administered by a physiotherapist.

What is being measured

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

  1. Sensory assesment of the children

    Sensory evaluation in the cases was made by evaluating the senses of stereognosis, graphesthesia, finger identification, and kinesthesia.

    Measured: May 2010

  2. Motor proficiency of the children

    Motor proficiency of the children was assessed by Bruiniks Oseretsky test.

    Measured: May 2010

Timeline

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

  1. First posted8 Apr 2022
  2. Study startJan 2010
  3. Primary completionAug 2010
  4. Study completionDec 2010

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
Case-control
Time perspective
Cross-sectional
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318677
Sponsor's protocol ID
OBaskan
Other IDs
AKitis
Status last verified
Apr 2022
First submitted
24 Mar 2022
Last updated
8 Apr 2022
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spina Bifida and Sensory Disorder, run by Pamukkale University.

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 0 inclusion and 1 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Sensory assesment of the children (time frame: May 2010). The study lists 2 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 8 Apr 2022.

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