Cerebral Palsy, SpasticNCT06343701
Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy
An observational study of Cerebral Palsy, Spastic, run by Abant Izzet Baysal University at 3 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are: There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Implicit motor imagery and Explicit motor imagery
- How many people
- 90 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 18 Jul 2023to 25 Jun 2024
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study included between the ages 6 and 18 years 10 children with unilateral and bilateral cerebral palsy with level 1 or 2 according to the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System (CFCS) and 10 typically developing children.
Who may be able to join
- Diagnosed with spastic type CP between the ages of 6-18
- Gross Motor Function Classification System (GMFSS) level 1- 2
- Manual Dexterity Classification System (EBSS) level 1-2
- Having at least 24 points from the Mini-Mental test for children,
- Having an IQ > 70,
- To be able to understand the instructions of the study.
Who cannot join
- Having severe vision, hearing or attention problems,
- Having advanced cardiovascular or cognitive problems,
- Not being able to follow work instructions,
- Having had upper extremity surgery within the last 6 months,
- Having received MI training in the last 6 months.
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Bolu Abant İzzet Baysal University
Bolu, Gölköy/ Bolu, 14030
Seda Ayaz Taş, Phd, 05495458040, seda.ayaztas@ibu.edu.tr
- Recruiting
Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Düzce, Merkez, 81100
Seda AYAZ TAŞ, Phd, 05495458040, seda.ayaztas@ibu.edu.tr
- Recruiting
Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi
Zonguldak, Ereğli, 67300
Seda AYAZ TAŞ, Phd, 05495458040, seda.ayaztas@ibu.edu.tr
About this study
The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:
- There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.
- There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.
- There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.
- There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children.
Read the detailed description
Cerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. Motor disorders in CP are often accompanied by sensory, perception, cognitive, communication, language and speech disorders, behavioral disorders, epilepsy, vision, hearing, endocrine, urogenital and secondary musculoskeletal system problems.
To date, CP has been classified by many researchers. The most recently used classification is the classification made by the Surveillance of Cerebral Palsy in Europe (SCPE) in 2000. According to this classification, SP; They are divided into 3 groups: spastic, dyskinetic and ataxic types. In spastic type CP, abnormal posture and movement patterns, increased muscle tone, pathological reflexes (Babinski, clonus, etc.) are dominant. The most common type of CP is spastic type CP. Spastic type CP is divided into bilateral and unilateral CP. Involvement in spastic bilateral CP, bilaterally in 4 extremities; In spastic unilateral CP, involvement occurs unilaterally in one half of the body. Dyskinetic type SP; It is characterized by abnormal posture and movement patterns, involuntary, uncontrollable, often stereotypic movements. It is divided into two groups: dystonic and choreoathetoid CP. While hypokinesia and hypertonus predominate in dystonic type CP, hyperkinesia and hypotonus predominate in choreoathetoid type CP. Ataxic type CP is characterized by coordination disorder in target-directed movements, gait and trunk control deficiencies, intention tremor, and speech disorder.
Recent studies indicate that motor disorders in children with CP are not only related to movement execution, but also to impairments in cognitive process, motor planning including motor control, and motor imagery ability.
Motor imagery refers to a mental process in which the individual mentally imagines a movement without actually performing an active movement. Studies have shown that similar brain regions are activated during movement performance and movement visualization. Motor imagined movements and actively performed motor movements occur in the premotor and parietal areas, basal ganglia and cerebellum. Based on this, motor imagery allows identifying the cognitive and cerebral properties of movement representation independently of motor output and sensory feedback.
Imagination is divided into two: express and implicit motor imagery. During express motor imagery, the person simulates a specific motor movement, that is, the individual is aware that he is visualizing the movement. Implicit motor imagery is the ability to engage with the projection and manipulation of the body schema from a first-person perspective. In implicit motor imagery, the movement is visualized unconsciously.
Implicit motor imagery skills will be evaluated Hand Laterality Task, Explicit motor imagery skills will be evaluated with Movement Imagery Questionnaire for Children (MIQ-C), mental chronometry and box block test. All assessments will be evaluated and recorded separately in the dominant and nondominant upper extremities as actual performance and imaged performance.
All evaluations will be made in between the ages of 6-18 typically developing children and children with unilateral and bilateral cerebral palsy with level 1 or 2 according to the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System (CFCS).
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Implicit motor imagery, Explicit motor imagery
- Keywords
- cerebral palsy, upper extremity, Imagination
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implicit motor imageryOther
Implicit motor imagery is the ability to engage with the projection and manipulation of the body schema from a first-person perspective. Implicit motor imagery skills were evaluated Recognize App Recognize Hand Hand Laterality Task with, developed by NOI group. (http://www.noigroup.com/ Recognise).
Explicit motor imageryOther
In explicit motor imagery, the person simulates a specific motor movement, that is, the individual is aware that she is imagining the movement.Explicit motor imagery skills were evaluated with Movement Imagery Questionnaire for Children (MIQ-C), mental chronometry and box block test.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral cerebral palsy | Cerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. In spastic unilateral CP, involvement occurs unilaterally in one half of the body. Receives: Other: Implicit motor imagery; Other: Explicit motor imagery | |
| Bilateral cerebral palsy | Cerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. In spastic bilateral CP, involvement is seen bilaterally in all 4 extremities. Receives: Other: Implicit motor imagery; Other: Explicit motor imagery | |
| Typically developing children | Children with typical development are children who behave in accordance with the developmental level expected for their age. Receives: Other: Implicit motor imagery; Other: Explicit motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explicit motor imagery -1
Box and block test,Participants were first asked to pass the maximum number of wooden blocks to the other side of the wooden box in 60 seconds, three times for each hand. The actual number of movement blocks was obtained by calculating the average of 3 applications. Then, each participant was asked to visually pass the maximum number of wooden blocks to the other side of the wooden box without moving, three times for both hands. While visualizing, the participants pressed the button in front of them for each wooden block they placed, thus the number of wooden blocks they imagined passing to the other side was seen. The number of imaged movement blocks was obtained by taking the average of 3 applications. The number of wooden blocks passed with actual movement and imagined movement was compared.
Measured: two years
Secondary outcomes (3)
Explicit motor imagery - 2
Box and block test, mental chronometry, The mental chronometry paradigm was evaluated using the wooden box and 10 wooden blocks of the box block test. The participants were first asked to grasp 10 wooden blocks from one side of the wooden box and pass them to the other side, three times in both hands, and the time taken was calculated with a stopwatch. Then, they were asked to visualize passing 10 wooden blocks to the other side of the wooden box, 3 times for each hand, and to say when they imagined that all 10 wooden blocks had passed. When they said they were done, the stopwatch was stopped. The application was performed three times on the dominant and non-dominant sides for real and imagined movements, and the average was noted. Delta time was calculated based on real and imagined movement time. . Delta time is calculated with the formula =[(real movement-imagined movement) / [(real movement+imagined movement) / 2]x100.
Measured: two years
Explicit motor imagery - 3
Movement Imagery Questionnaire for Children (MIQ-C),The Movement Imagination Questionnaire for Children will be used to measure visual (intrinsic, extrinsic) and kinesthetic imagery ability. It contains a total of 12 items: 4 items on internal, 4 items on external, and 4 items on kinesthetic visualization skills. Within the scope of the survey, the individual will be asked to visualize 4 different movements from 3 different visualization perspectives. The individual will be expected to first actually perform the movement in the instruction once and then imagine doing the movement. The clarity of this imagery will be rated using a Likert-type scale from 1 (very difficult to feel) to 7 (very easy to feel). A higher score from the test indicates higher imagination ability.
Measured: two years
Implicit motor imagery
Hand Laterality Task, Implicit motor imagery capacity was assessed with the Laterality Task (choice task). Laterality task is based on deciding which side of the photograph belongs to the limb shown. Recognize Hand is an application developed by the NOI group and used to evaluate right-left discrimination.(http://www.noigroup.com/ Recognise). In terms of imagination ability and hand laterality, the sharpness of the choices made in right-left discrimination (percentage of correct answers) and the reaction time during the choice were evaluated.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start18 Jul 2023
- Primary completion5 May 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
- Investigators
- Seda Ayaz Taş, Phd, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343701
- Sponsor's protocol ID
- BAİBÜ-SAT4
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06343701
- Acronym / sponsor ID
- BAİBÜ-SAT4
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- cerebral palsy, upper extremity, Imagination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 5 May 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:
- There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.
- There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.
- There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.
- There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children.
Detailed description
Cerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. Motor disorders in CP are often accompanied by sensory, perception, cognitive, communication, language and speech disorders, behavioral disorders, epilepsy, vision, hearing, endocrine, urogenital and secondary musculoskeletal system problems.
To date, CP has been classified by many researchers. The most recently used classification is the classification made by the Surveillance of Cerebral Palsy in Europe (SCPE) in 2000. According to this classification, SP; They are divided into 3 groups: spastic, dyskinetic and ataxic types. In spastic type CP, abnormal posture and movement patterns, increased muscle tone, pathological reflexes (Babinski, clonus, etc.) are dominant. The most common type of CP is spastic type CP. Spastic type CP is divided into bilateral and unilateral CP. Involvement in spastic bilateral CP, bilaterally in 4 extremities; In spastic unilateral CP, involvement occurs unilaterally in one half of the body. Dyskinetic type SP; It is characterized by abnormal posture and movement patterns, involuntary, uncontrollable, often stereotypic movements. It is divided into two groups: dystonic and choreoathetoid CP. While hypokinesia and hypertonus predominate in dystonic type CP, hyperkinesia and hypotonus predominate in choreoathetoid type CP. Ataxic type CP is characterized by coordination disorder in target-directed movements, gait and trunk control deficiencies, intention tremor, and speech disorder.
Recent studies indicate that motor disorders in children with CP are not only related to movement execution, but also to impairments in cognitive process, motor planning including motor control, and motor imagery ability.
Motor imagery refers to a mental process in which the individual mentally imagines a movement without actually performing an active movement. Studies have shown that similar brain regions are activated during movement performance and movement visualization. Motor imagined movements and actively performed motor movements occur in the premotor and parietal areas, basal ganglia and cerebellum. Based on this, motor imagery allows identifying the cognitive and cerebral properties of movement representation independently of motor output and sensory feedback.
Imagination is divided into two: express and implicit motor imagery. During express motor imagery, the person simulates a specific motor movement, that is, the individual is aware that he is visualizing the movement. Implicit motor imagery is the ability to engage with the projection and manipulation of the body schema from a first-person perspective. In implicit motor imagery, the movement is visualized unconsciously.
Implicit motor imagery skills will be evaluated Hand Laterality Task, Explicit motor imagery skills will be evaluated with Movement Imagery Questionnaire for Children (MIQ-C), mental chronometry and box block test. All assessments will be evaluated and recorded separately in the dominant and nondominant upper extremities as actual performance and imaged performance.
All evaluations will be made in between the ages of 6-18 typically developing children and children with unilateral and bilateral cerebral palsy with level 1 or 2 according to the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System (CFCS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral cerebral palsy | – | Other: Implicit motor imagery, Other: Explicit motor imageryCerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. In spastic unilateral CP, involvement occurs unilaterally in one half of the body. |
| Bilateral cerebral palsy | – | Other: Implicit motor imagery, Other: Explicit motor imageryCerebral Palsy (CP) is a group of permanent disorders in activity limitation, motor and posture development due to non-progressive damage to the developing fetus or infant brain. In spastic bilateral CP, involvement is seen bilaterally in all 4 extremities. |
| Typically developing children | – | Other: Implicit motor imagery, Other: Explicit motor imageryChildren with typical development are children who behave in accordance with the developmental level expected for their age. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study included between the ages 6 and 18 years 10 children with unilateral and bilateral cerebral palsy with level 1 or 2 according to the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System (CFCS) and 10 typically developing children.
Key inclusion criteria (6 listed)
- Diagnosed with spastic type CP between the ages of 6-18
- Gross Motor Function Classification System (GMFSS) level 1- 2
- Manual Dexterity Classification System (EBSS) level 1-2
- Having at least 24 points from the Mini-Mental test for children,
- Having an IQ > 70,
Key exclusion criteria (5 listed)
- Having severe vision, hearing or attention problems,
- Having advanced cardiovascular or cognitive problems,
- Not being able to follow work instructions,
- Having had upper extremity surgery within the last 6 months,
- Having received MI training in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implicit motor imageryImplicit motor imagery is the ability to engage with the projection and manipulation of the body schema from a first-person perspective. Implicit motor imagery skills were evaluated Recognize App Recognize Hand Hand Laterality Task with, developed by NOI group. (http://www.noigroup.com/ Recognise). | Other | Bilateral cerebral palsy, Typically developing children, Unilateral cerebral palsy |
| Explicit motor imageryIn explicit motor imagery, the person simulates a specific motor movement, that is, the individual is aware that she is imagining the movement.Explicit motor imagery skills were evaluated with Movement Imagery Questionnaire for Children (MIQ-C), mental chronometry and box block test. | Other | Bilateral cerebral palsy, Typically developing children, Unilateral cerebral palsy |
Primary outcome
Explicit motor imagery -1
Time frame: two years
Box and block test,Participants were first asked to pass the maximum number of wooden blocks to the other side of the wooden box in 60 seconds, three times for each hand. The actual number of movement blocks was obtained by calculating the average of 3 applications. Then, each participant was asked to visually pass the maximum number of wooden blocks to the other side of the wooden box without moving, three times for both hands. While visualizing, the participants pressed the button in front of them for each wooden block they placed, thus the number of wooden blocks they imagined passing to the other side was seen. The number of imaged movement blocks was obtained by taking the average of 3 applications. The number of wooden blocks passed with actual movement and imagined movement was compared.
3 secondary outcomes
Explicit motor imagery - 2
Time frame: two years
Explicit motor imagery - 3
Time frame: two years
Implicit motor imagery
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
Seda Ayaz Taş, Phd principal investigator
Abant Izzet Baysal University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, Spastic, run by Abant Izzet Baysal University at 3 sites in Turkey (Türkiye).
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda Ayaz Taş, Phd (05495458040, seda.ayaztas@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit motor imagery -1 (time frame: two years). 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 3 Apr 2024.