Spastic Cerebral PalsyNCT06610370
Predicting Postoperative Ambulation Following Selective Dorsal Rhizotomy Based on Preoperative Gross Motor Function Score
An observational study of Spastic Cerebral Palsy and Walking, Difficulty, 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 resulting from permanent, nonprogressive damage to the developing brain before, during, or after birth (Tedla \& Reddy, 2021). Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Spastic Cerebral Palsy, Walking, Difficulty, Ambulation Difficulty
- What is being tested?
- Group 1
- How many people
- 95 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 1 day to 17 years
- All sexes
- Child
Study population: 95 children with spastic cerebral palsy were included in the study.
Who may be able to join
- Age between 0-17,
- Diagnosis of spastic CP,
- Participants and parents willing to participate in the study voluntarily,
- Gross Motor Function Classification System (GMFCS) level between II-IV,
- No history of orthopedic surgery before SDR surgery,
- 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 hemiparetic type CP
- Having a history of any surgery on the musculoskeletal system before SDR surgery
- Having received 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 resulting from permanent, nonprogressive 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 of CP is spastic, accounting for approximately 85% of all CP cases (Paul et al., 2022). It is divided into 3 types: hemiparetic, diparetic, and quadriparetic. Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with bilateral spastic type CP (Novak et al., 2014). One of the most important points in the decision-making process for SDR surgery is the compatibility of the family's expectations with the expectations of the healthcare professional. Informing the family about the expectations is very important in the decision-making process for surgery (Waite et al., 2023). No study has been found in the literature that provides objective predictive value before surgery in terms of postoperative ambulation. The aim of this study is to examine the predictability of postoperative ambulation status in patients with Spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.
Read the detailed description
It is an observational study. Purpose of the study: The aim of this study was to examine the predictability of postoperative ambulation status in patients with spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.
95 children with CP were included in the study. Among SCP cases, 71(74.7%) were diparetic, 18(18.9%) were quadriparetic, and 6 (6.3%) were triplegia.
- Can the total score of a gross motor function measure before SDR predict walking after SDR?
- Can the gross motor function measure total score before SDR surgery provide an indication of the family's postoperative walking expectations?
The Gross Motor Function Measure-88 (GMFM-88) and the Gross Motor Function Classification System (GMFCS) were applied to the participants.
- Being tested
- Group 1
- Keywords
- cerebral palsy, ambulation, selective dorsal rhizotomy, gross motor function
- Medical subject headings
- Cerebral Palsy, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
95 children with spastic cerebral palsy were included. Gross Motor Function Measure-88 (GMFM-88) and Gross Motor Function Classification System (GMFCS) were applied to the cases before and after the Selective Dorsal Rhizotomy (SDR) surgery.
| Study group | Role | What they receive |
|---|---|---|
| Children with Spastic Cerebral Palsy | 95 children with spastic cerebral palsy were included. Gross Motor Function Measure-88 (GMFM-88) and Gross Motor Function Classification System (GMFCS) were applied to the cases before and after the Selective Dorsal Rhizotomy (SDR) surgery. Receives: Other: Group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88 (GMFM-88)
It is an observational scale developed to evaluate gross motor skills and determine limitations in children with CP. Gross motor function is evaluated in 5 sections: supine-prone position and turning, 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
Gross Motor Function Classification System (GMFCS)
It is used to classify motor disorders in children with CP and to describe the severity and course of the disease. The functional status of children with CP is defined in 5 levels. The main difference between the levels is that there is a place for daily living activities. Level I; describes walking without restrictions; level V: describes being carried in a manually propelled wheelchair. The main difference between the levels is that daily life activities also have a place. Every level has its own definition for a variety of ages. The evaluation was made according to the definitions given according to the age of each child.
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 Spastic 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
- 95 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
- NCT06610370
- Sponsor's protocol ID
- NesliYildizdagi
- 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 participants 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
- Predicting Postoperative Ambulation Following Selective Dorsal Rhizotomy Based on Preoperative Gross Motor Function Score
- ClinicalTrials.gov ID
- NCT06610370
- Acronym / sponsor ID
- NesliYildizdagi
- Keywords
- cerebral palsy, ambulation, selective dorsal rhizotomy, gross motor function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 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 resulting from permanent, nonprogressive 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 of CP is spastic, accounting for approximately 85% of all CP cases (Paul et al., 2022). It is divided into 3 types: hemiparetic, diparetic, and quadriparetic. Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with bilateral spastic type CP (Novak et al., 2014). One of the most important points in the decision-making process for SDR surgery is the compatibility of the family's expectations with the expectations of the healthcare professional. Informing the family about the expectations is very important in the decision-making process for surgery (Waite et al., 2023). No study has been found in the literature that provides objective predictive value before surgery in terms of postoperative ambulation. The aim of this study is to examine the predictability of postoperative ambulation status in patients with Spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.
Detailed description
It is an observational study. Purpose of the study: The aim of this study was to examine the predictability of postoperative ambulation status in patients with spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.
95 children with CP were included in the study. Among SCP cases, 71(74.7%) were diparetic, 18(18.9%) were quadriparetic, and 6 (6.3%) were triplegia.
- Can the total score of a gross motor function measure before SDR predict walking after SDR?
- Can the gross motor function measure total score before SDR surgery provide an indication of the family's postoperative walking expectations?
The Gross Motor Function Measure-88 (GMFM-88) and the Gross Motor Function Classification System (GMFCS) were applied to the participants.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Spastic Cerebral Palsy | – | Other: Group 195 children with spastic cerebral palsy were included. Gross Motor Function Measure-88 (GMFM-88) and Gross Motor Function Classification System (GMFCS) were applied to the cases before and after the Selective Dorsal Rhizotomy (SDR) surgery. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- 95 children with spastic cerebral palsy were included in the study.
Key inclusion criteria (6 listed)
- Age between 0-17,
- Diagnosis of spastic CP,
- Participants and parents willing to participate in the study voluntarily,
- Gross Motor Function Classification System (GMFCS) level between II-IV,
- No history of orthopedic surgery before SDR surgery,
Key exclusion criteria (4 listed)
- Having different types of CP such as dyskinetic, ataxic and mixed type
- Having hemiparetic type CP
- Having a history of any surgery on the musculoskeletal system before SDR surgery
- Having received 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 195 children with spastic cerebral palsy were included. Gross Motor Function Measure-88 (GMFM-88) and Gross Motor Function Classification System (GMFCS) were applied to the cases before and after the Selective Dorsal Rhizotomy (SDR) surgery. | Other | Children with Spastic Cerebral Palsy |
Primary outcome
Gross Motor Function Measure-88 (GMFM-88)
Time frame: baseline
It is an observational scale developed to evaluate gross motor skills and determine limitations in children with CP. Gross motor function is evaluated in 5 sections: supine-prone position and turning, 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.
Gross Motor Function Classification System (GMFCS)
Time frame: baseline
It is used to classify motor disorders in children with CP and to describe the severity and course of the disease. The functional status of children with CP is defined in 5 levels. The main difference between the levels is that there is a place for daily living activities. Level I; describes walking without restrictions; level V: describes being carried in a manually propelled wheelchair. The main difference between the levels is that daily life activities also have a place. Every level has its own definition for a variety of ages. The evaluation was made according to the definitions given according to the age of each child.
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 participants 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 Spastic Cerebral Palsy and Walking, Difficulty, 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?
Gross Motor Function Measure-88 (GMFM-88) (time frame: baseline). 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 26 Sep 2024.