Diplegic Cerebral PalsyNCT06610357
Evaluation of Long-Term Effects of Selective Dorsal Rhizotomy Surgery on Function and Mobility in Children With Cerebral Palsy Using the International Classification of Functioning, Disability, and Health (ICF) Model
An observational study of Diplegic Cerebral Palsy and Muscle Tone Abnormalities, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills as a result of permanent, non-progressive damage to the developing brain before, during, or after birth (Tedla \& Reddy, 2021). Read more about this study
- Who is it for?
- Ages 0 days to 17 years
- Conditions the study is for
- Diplegic Cerebral Palsy, Muscle Tone Abnormalities
- What is being tested?
- Group 1
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 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 0 days to 17 years
- All sexes
- Child
Study population: 42 children with Diparetic Cerebral Palsy were included in the study.
Who may be able to join
- Their ages must be between 0-17,
- They must be diagnosed with diparetic CP,
- The participants and their parents want to participate in the study voluntarily
- The Gross Motor Function Classification System (GMFSS) level II-IV
- Having a sitting level between 4-8 according to the Level Sitting Scale (LSS)
- Actively continuing the Physiotherapy and Rehabilitation (PTR) program for at least 2 months in the post-operative period.
Who cannot join
- Having different types of CP such as dyskinetic, ataxic and mixed type
- Having spastic quadriparetic or hemiparetic type of CP
- Having any surgical history on the musculoskeletal system,
- Having Botulinum Toxin injection within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Altunizade Hospital
Istanbul, AA, 34662
About this study
Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills as a result of permanent, non-progressive damage to the developing brain before, during, or after birth (Tedla \& Reddy, 2021). The worldwide prevalence of CP is 2-3 per 1000 live births (Paul et al., 2022). The most common type is spastic type CP with a prevalence rate of 70-80% (Christensen et al., 2014). Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014). In diparetic CP (DCP); lower extremity involvement is more prominent than upper extremity involvement (Elbasan et al., 2017). Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with spastic diparetic CP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020). Studies in the literature have revealed the long-term effects of SDR through surveys. Many problems are observed in individuals with CP. It is very important to evaluate the situation in detail in order to analyze it well. It is recommended to use the International Classification of Functioning, Disability and Health (ICF) model, which creates a framework to evaluate children with a diagnosis of DCP in a healthy way and develop effective treatment strategies (Riyahi et al., 2024). ICF enables the identification of situations related to human functionality and limitations and creates a framework (Çankaya \& Seyhan, 2016). The aim of this study is to evaluate the late effects of SDR surgery on function and mobility in cases with DCP using the ICF model.
Read the detailed description
It's an observational study. Purpose of the study: This study aims to assess the long-term impact of SDR surgery on function and mobility in children with CP using the ICF model.
The study included 42 diparetic CP cases. These cases were aged between 2-9 years, with a mean age of 4.7±1.7 years.
- How did the long-term the Modified Ashworth Scale (MAS) values after SDR change compared to before the operation?
- How did the long-term the Gross Motor Function Measure-88 (GMFM-88) values after SDR change compared to before the operation?
- How did the long-term the Children's Functional Independence Measure (WeeFIM)- Mobility scores after SDR change compared to before the operation?
The Modified Ashworth Scale (MAS), the Gross Motor Function Measure-88 (GMFM-88) and the Children's Functional Independence Measure (WeeFIM)-Mobility section were applied to the participants.
- Conditions
- Diplegic Cerebral Palsy, Muscle Tone Abnormalities
- Being tested
- Group 1
- Keywords
- Cerebral Palsy, ICF, Muscle Tone, Mobility, Long-Term effects, Selective Dorsal Rhizotomy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
42 diparetic children with cerebral palsy were included in the study. The Modified Ashworth Scale (MAS), the Children's Functional Independence Measure (WeeFIM)-Mobility section and the Gross Motor Function Measure-88 (GMFM-88) were applied before and after SDR surgery.
| Study group | Role | What they receive |
|---|---|---|
| Children with diparetic serebral palsy | 42 diparetic children with cerebral palsy were included in the study. The Modified Ashworth Scale (MAS), the Children's Functional Independence Measure (WeeFIM)-Mobility section and the Gross Motor Function Measure-88 (GMFM-88) were applied before and after SDR surgery. Receives: Other: Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Ashworth Scale (MAS)
It is used to describe the muscle's resistance to passive movement, the ease with which the joint can be moved within the available range. It is a 6-point scale that measures the muscle's resistance to passive movement by passively moving the joint through its possible normal range of motion. Within the scope of the study, lower extremity muscles; hip flexors, hip adductors, hip internal rotators, knee flexors, knee extensors and ankle plantar flexors will be evaluated with MAS.
Measured: baseline
The Gross Motor Function Measure-88 (GMFM-88)
It is an observational scale developed to evaluate the gross motor skills of children with CP and identify limitations. Gross motor function is evaluated in 5 sections: supine position and rolling over, sitting, crawling and kneeling, standing and walking-running and jumping. It consists of a total of 88 items. Each item is scored as 0, 1, 2, 3 or "not tested" and the total score and percentage (%) are calculated.
Measured: baseline
The Children's Functional Independence Measure (WeeFIM)
It was developed to evaluate the functional independence levels of children with developmental disorders in daily living activities. The scale consists of 6 parts: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored between 1-7. 1 point, complete dependence; 7 points indicate complete independence. A total of minimum 18 (fully dependent) points and a maximum of 126 (fully independent) points can be obtained.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Sep 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Yildizdagi, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610357
- Sponsor's protocol ID
- NYildizdagii
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-Term Effects of Selective Dorsal Rhizotomy Surgery on Function and Mobility in Children With Cerebral Palsy Using the International Classification of Functioning, Disability, and Health (ICF) Model
- ClinicalTrials.gov ID
- NCT06610357
- Acronym / sponsor ID
- NYildizdagii
- Conditions
- Diplegic Cerebral Palsy, Muscle Tone Abnormalities
- Keywords
- Cerebral Palsy, ICF, Muscle Tone, Mobility, Long-Term effects, Selective Dorsal Rhizotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Sep 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.
Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills as a result of permanent, non-progressive damage to the developing brain before, during, or after birth (Tedla \& Reddy, 2021). The worldwide prevalence of CP is 2-3 per 1000 live births (Paul et al., 2022). The most common type is spastic type CP with a prevalence rate of 70-80% (Christensen et al., 2014). Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014). In diparetic CP (DCP); lower extremity involvement is more prominent than upper extremity involvement (Elbasan et al., 2017). Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with spastic diparetic CP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020). Studies in the literature have revealed the long-term effects of SDR through surveys. Many problems are observed in individuals with CP. It is very important to evaluate the situation in detail in order to analyze it well. It is recommended to use the International Classification of Functioning, Disability and Health (ICF) model, which creates a framework to evaluate children with a diagnosis of DCP in a healthy way and develop effective treatment strategies (Riyahi et al., 2024). ICF enables the identification of situations related to human functionality and limitations and creates a framework (Çankaya \& Seyhan, 2016). The aim of this study is to evaluate the late effects of SDR surgery on function and mobility in cases with DCP using the ICF model.
Detailed description
It's an observational study. Purpose of the study: This study aims to assess the long-term impact of SDR surgery on function and mobility in children with CP using the ICF model.
The study included 42 diparetic CP cases. These cases were aged between 2-9 years, with a mean age of 4.7±1.7 years.
- How did the long-term the Modified Ashworth Scale (MAS) values after SDR change compared to before the operation?
- How did the long-term the Gross Motor Function Measure-88 (GMFM-88) values after SDR change compared to before the operation?
- How did the long-term the Children's Functional Independence Measure (WeeFIM)- Mobility scores after SDR change compared to before the operation?
The Modified Ashworth Scale (MAS), the Gross Motor Function Measure-88 (GMFM-88) and the Children's Functional Independence Measure (WeeFIM)-Mobility section were applied to the participants.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with diparetic serebral palsy | – | Other: Group 142 diparetic children with cerebral palsy were included in the study. The Modified Ashworth Scale (MAS), the Children's Functional Independence Measure (WeeFIM)-Mobility section and the Gross Motor Function Measure-88 (GMFM-88) were applied before and after SDR surgery. |
Who may qualify
- Ages
- 0 days to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- 42 children with Diparetic Cerebral Palsy were included in the study.
Key inclusion criteria (6 listed)
- Their ages must be between 0-17,
- They must be diagnosed with diparetic CP,
- The participants and their parents want to participate in the study voluntarily
- The Gross Motor Function Classification System (GMFSS) level II-IV
- Having a sitting level between 4-8 according to the Level Sitting Scale (LSS)
Key exclusion criteria (4 listed)
- Having different types of CP such as dyskinetic, ataxic and mixed type
- Having spastic quadriparetic or hemiparetic type of CP
- Having any surgical history on the musculoskeletal system,
- Having Botulinum Toxin injection within 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 |
|---|---|---|
| Group 142 diparetic children with cerebral palsy were included in the study. The Modified Ashworth Scale (MAS), the Children's Functional Independence Measure (WeeFIM)-Mobility section and the Gross Motor Function Measure-88 (GMFM-88) were applied before and after SDR surgery. | Other | Children with diparetic serebral palsy |
Primary outcome
The Modified Ashworth Scale (MAS)
Time frame: baseline
It is used to describe the muscle's resistance to passive movement, the ease with which the joint can be moved within the available range. It is a 6-point scale that measures the muscle's resistance to passive movement by passively moving the joint through its possible normal range of motion. Within the scope of the study, lower extremity muscles; hip flexors, hip adductors, hip internal rotators, knee flexors, knee extensors and ankle plantar flexors will be evaluated with MAS.
The Gross Motor Function Measure-88 (GMFM-88)
Time frame: baseline
It is an observational scale developed to evaluate the gross motor skills of children with CP and identify limitations. Gross motor function is evaluated in 5 sections: supine position and rolling over, sitting, crawling and kneeling, standing and walking-running and jumping. It consists of a total of 88 items. Each item is scored as 0, 1, 2, 3 or "not tested" and the total score and percentage (%) are calculated.
The Children's Functional Independence Measure (WeeFIM)
Time frame: baseline
It was developed to evaluate the functional independence levels of children with developmental disorders in daily living activities. The scale consists of 6 parts: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored between 1-7. 1 point, complete dependence; 7 points indicate complete independence. A total of minimum 18 (fully dependent) points and a maximum of 126 (fully independent) points can be obtained.
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 26 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diplegic Cerebral Palsy and Muscle Tone Abnormalities, run by Acıbadem Atunizade Hospital at 1 site 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 4 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 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
The Modified Ashworth Scale (MAS) (time frame: baseline). The study lists 3 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 26 Sep 2024.