Spina BifidaNCT05318677
Sensory and Motor Proficiency For Children With Spina Bifida
An observational study of Spina Bifida and Sensory Disorder, run by Pamukkale University.
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 group | Role | What they receive |
|---|---|---|
| 1 | Fifteen 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. | |
| 2 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted8 Apr 2022
- Study startJan 2010
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Baskan, Pamukkale University
- Investigators
- Ozden Baskan, Principal investigator, Pamukkale University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sensory and Motor Proficiency For Children With Spina Bifida
- ClinicalTrials.gov ID
- NCT05318677
- Acronym / sponsor ID
- OBaskan
- Keywords
- spina bifida, upper extremity function, sense, motor function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Fifteen 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. |
| 2 | – | –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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Children who had a second illness and could not be contacted were not included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory assesment of the children
Time frame: May 2010
Sensory evaluation in the cases was made by evaluating the senses of stereognosis, graphesthesia, finger identification, and kinesthesia.
Motor proficiency of the children
Time frame: May 2010
Motor proficiency of the children was assessed by Bruiniks Oseretsky test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozden Baskan principal investigator
Pamukkale University
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.