Cerebral Palsy Spastic DiplegiaNCT06617507
The Effect of Selective Dorsal Rhizotomy Surgery on Walking in Children With Ambulatory Cerebral Palsy in Turkey
An observational study of Cerebral Palsy Spastic Diplegia and Gait, Spastic, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a motor disorder that develops during fetal brain development or due to non-progressive damage to the developing infant brain. These movement and posture disorders are classified as Spastic Type, Dyskinetic Type, Ataxic Type and Mixed Type (Rosenbaum, 2007). Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia, Gait, Spastic
- What is being tested?
- Group 1
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Sep 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 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.
Who may be able to join
- Being between the ages of 0-17
- Being diagnosed with Diparetic CP, one of the types of Cerebral Palsy
Who cannot join
- Having any history of orthopedic surgery on the musculoskeletal system
- Having Botulinum Toxin injection in the last 6 months
- Using of Baclofen Pump
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Altunizade Hospital
Istanbul, Altunizade, 34662
About this study
Cerebral Palsy (CP) is a motor disorder that develops during fetal brain development or due to non-progressive damage to the developing infant brain. These movement and posture disorders are classified as Spastic Type, Dyskinetic Type, Ataxic Type and Mixed Type (Rosenbaum, 2007). Spastic type CP accounts for 20% of all CP cases. Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014).
Lower extremity involvement is more common in diparetic cerebral palsy (DCP) (Donker et al., 2008). 98% of DCP cases vary between GMFS levels I and III. Walking rates are between 86-91% (Novak et al., 2014). Children with DCP can usually walk until the age of 4 (Cottalorda, 1998). However, these walks are often; Due to spasticity, muscle weakness, involuntary co-contraction, deficiencies in selective motor control, balance problems, structural changes of soft tissue and compensatory mechanisms (Manca, 2014), it can lead to musculoskeletal system problems and gait pathologies. Although the cerebral lesion that causes is static, children with spastic diplegia increase in height with age, and they may lose their ability to walk because bone length cannot be accompanied by muscle length at the same rate (Miller, 2020).
Read more
Selective Dorsal Rhizotomy (SDR) surgery is an effective method for spasticity management in children with spastic DCP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020).
It has been stated that SDR surgery applied to carefully selected candidates may be beneficial on gait quality in individuals with ambulatory CP (Chen, 2019). SDR surgery has been found to improve walking as a result of information collected from patients through a survey (Park, 2021). The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.
Read the detailed description
It's an observational study. Purpose of the study: The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.
A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.
- What is the effect of SDR surgery performed in Turkey on gait function in children with CP?
- How did the muscle tone of the participants change after the SDR operation?
The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.
- Conditions
- Cerebral Palsy Spastic Diplegia, Gait, Spastic
- Being tested
- Group 1
- Keywords
- Cerebral Palsy, Gait, Selective Dorsal Rhizotomy, Ambulation
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Other
The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Children with diparetic cerebral palsy | 20 ambulatory diparetic CP cases were included. The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants. 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 a 6-point scale used to describe the muscle's resistance to passive movement and the ease with which the joint can be moved within the available range. It is frequently used in clinical settings. Its evaluation and interpretation are quite practical. Within the scope of the study, lower extremity muscles were evaluated with MAS.
Measured: baseline
The Gillette Functional Assessment Questionnaire (FAQ)
It is a measurement tool used to evaluate walking ability and functional mobility in children. This questionnaire was developed specifically to evaluate the walking functions of children with CP and other neuromuscular disorders. Developed at Gillette Children's Hospital, this survey aims to rate children's walking abilities in different environments. Scores children's walking skills between 1-10.
Measured: baseline
The Edinburgh Visual Gait Score (EVGS)
EVGS is a valid and reliable gait analysis method used in gait evaluation in children with CP. It is a practically used gait analysis that supports observational gait analysis, especially in children with CP with mild involvement and distal deformities. In EVGS, evaluation is made by video recording method. It consists of 17 parameters and evaluates gait in frontal, sagittal and transverse planes. In each lower extremity, 6 anatomical regions, namely trunk, pelvis, hip, knee, ankle and foot, are evaluated separately during the stance and swing phases of gait.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 May 2024
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Gurzoglu, Acıbadem Atunizade Hospital
- Investigators
- Gizem Gürzoğlu, Study director, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617507
- Sponsor's protocol ID
- GGurzoglu2
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 27 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selective Dorsal Rhizotomy Surgery on Walking in Children With Ambulatory Cerebral Palsy in Turkey
- ClinicalTrials.gov ID
- NCT06617507
- Acronym / sponsor ID
- GGurzoglu2
- Conditions
- Cerebral Palsy Spastic Diplegia, Gait, Spastic
- Keywords
- Cerebral Palsy, Gait, Selective Dorsal Rhizotomy, Ambulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 27 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 motor disorder that develops during fetal brain development or due to non-progressive damage to the developing infant brain. These movement and posture disorders are classified as Spastic Type, Dyskinetic Type, Ataxic Type and Mixed Type (Rosenbaum, 2007). Spastic type CP accounts for 20% of all CP cases. Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014).
Lower extremity involvement is more common in diparetic cerebral palsy (DCP) (Donker et al., 2008). 98% of DCP cases vary between GMFS levels I and III. Walking rates are between 86-91% (Novak et al., 2014). Children with DCP can usually walk until the age of 4 (Cottalorda, 1998). However, these walks are often; Due to spasticity, muscle weakness, involuntary co-contraction, deficiencies in selective motor control, balance problems, structural changes of soft tissue and compensatory mechanisms (Manca, 2014), it can lead to musculoskeletal system problems and gait pathologies. Although the cerebral lesion that causes is static, children with spastic diplegia increase in height with age, and they may lose their ability to walk because bone length cannot be accompanied by muscle length at the same rate (Miller, 2020).
Selective Dorsal Rhizotomy (SDR) surgery is an effective method for spasticity management in children with spastic DCP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020).
It has been stated that SDR surgery applied to carefully selected candidates may be beneficial on gait quality in individuals with ambulatory CP (Chen, 2019). SDR surgery has been found to improve walking as a result of information collected from patients through a survey (Park, 2021). The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.
Detailed description
It's an observational study. Purpose of the study: The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.
A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.
- What is the effect of SDR surgery performed in Turkey on gait function in children with CP?
- How did the muscle tone of the participants change after the SDR operation?
The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) 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 cerebral palsy | – | Other: Group 120 ambulatory diparetic CP cases were included. The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.
Key inclusion criteria (2 listed)
- Being between the ages of 0-17
- Being diagnosed with Diparetic CP, one of the types of Cerebral Palsy
Key exclusion criteria (3 listed)
- Having any history of orthopedic surgery on the musculoskeletal system
- Having Botulinum Toxin injection in the last 6 months
- Using of Baclofen Pump
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 1The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants. | Other | Children with diparetic cerebral palsy |
Primary outcome
The Modified Ashworth Scale (MAS)
Time frame: baseline
It is a 6-point scale used to describe the muscle's resistance to passive movement and the ease with which the joint can be moved within the available range. It is frequently used in clinical settings. Its evaluation and interpretation are quite practical. Within the scope of the study, lower extremity muscles were evaluated with MAS.
The Gillette Functional Assessment Questionnaire (FAQ)
Time frame: baseline
It is a measurement tool used to evaluate walking ability and functional mobility in children. This questionnaire was developed specifically to evaluate the walking functions of children with CP and other neuromuscular disorders. Developed at Gillette Children's Hospital, this survey aims to rate children's walking abilities in different environments. Scores children's walking skills between 1-10.
The Edinburgh Visual Gait Score (EVGS)
Time frame: baseline
EVGS is a valid and reliable gait analysis method used in gait evaluation in children with CP. It is a practically used gait analysis that supports observational gait analysis, especially in children with CP with mild involvement and distal deformities. In EVGS, evaluation is made by video recording method. It consists of 17 parameters and evaluates gait in frontal, sagittal and transverse planes. In each lower extremity, 6 anatomical regions, namely trunk, pelvis, hip, knee, ankle and foot, are evaluated separately during the stance and swing phases of gait.
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 27 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
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Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
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Effects of Transcranial Direct Current Stimulation Combined With Virtual Reality on Gait and Self-Esteem in Children With Spastic Cerebral Palsy
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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.
Gizem Gürzoğlu study director
Acıbadem Atunizade Hospital
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 Cerebral Palsy Spastic Diplegia and Gait, Spastic, 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 2 inclusion and 3 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 27 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 27 Sep 2024.