Cerebral PalsyNCT05295563
Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Muscle Spasticity, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Muscle Spasticity, Vascularization
- What is being tested?
- Evaluation
- Type of treatment
- Injection or infusion
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 May 2022
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years, who had previously been injected with BoNT-A into the gastrocnemius muscle, who can cooperate were included in the study.
Who may be able to join
- Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years
- Children who had previously been injected with BoNT-A into the gastrocnemius muscle
Who cannot join
- Children with dyskinetic, ataxic, and hypotonic type CP
- Children with a history of any surgical operation or botulinum toxin injection treatment in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy
One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. BoNT-A injections can be administered as a single dose, and some patients require repeated injections. The aim of this study was to examine the effects of repeated BoNT-A applications applied to the gastrocnemius muscle of children with CP on muscle morphology and functionality.
Read the detailed description
The study will be planned to include 50 children with CP. The children will be divided into two groups.Children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. Functionality of children with CP was evaluated with gross motor function measure (GMFM), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.
- Conditions
- Cerebral Palsy, Muscle Spasticity, Vascularization
- Being tested
- Evaluation
- Keywords
- Repeated botulinum toxin injections, Muscle morphology, Functionality
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle), muscle stiffness, muscle vascularization and functionality of children with CP will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Children who had been injected once or twice before were included in Group 1. Receives: Other: Evaluation | |
| Group 2 | Children who received 3 or more injections were included in Group 2. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle morphology
Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.
Measured: Through study completion, an average of 1 year
Muscle stiffness
Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.
Measured: Through study completion, an average of 1 year
Muscle vascularization
Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.
Measured: Through study completion, an average of 1 year
Functionality 1
One of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist.
Measured: Through study completion, an average of 1 year
Functionality 2
One of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist.
Measured: Through study completion, an average of 1 year
Functionality 3
One of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist.
Measured: Through study completion, an average of 1 year
Functionality 4
One of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 May 2021
- Primary completion30 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamile Uzun Akkaya, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295563
- Sponsor's protocol ID
- KamileUzunAkkaya
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05295563
- Acronym / sponsor ID
- KamileUzunAkkaya
- Conditions
- Cerebral Palsy, Muscle Spasticity, Vascularization
- Keywords
- Repeated botulinum toxin injections, Muscle morphology, Functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 25 Mar 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.
One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. BoNT-A injections can be administered as a single dose, and some patients require repeated injections. The aim of this study was to examine the effects of repeated BoNT-A applications applied to the gastrocnemius muscle of children with CP on muscle morphology and functionality.
Detailed description
The study will be planned to include 50 children with CP. The children will be divided into two groups.Children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. Functionality of children with CP was evaluated with gross motor function measure (GMFM), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: EvaluationChildren who had been injected once or twice before were included in Group 1. |
| Group 2 | – | Other: EvaluationChildren who received 3 or more injections were included in Group 2. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years, who had previously been injected with BoNT-A into the gastrocnemius muscle, who can cooperate were included in the study.
Key inclusion criteria (2 listed)
- Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years
- Children who had previously been injected with BoNT-A into the gastrocnemius muscle
Key exclusion criteria (2 listed)
- Children with dyskinetic, ataxic, and hypotonic type CP
- Children with a history of any surgical operation or botulinum toxin injection treatment in the previous 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 |
|---|---|---|
| EvaluationGastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle), muscle stiffness, muscle vascularization and functionality of children with CP will be evaluated. | Other | Group 1, Group 2 |
Primary outcome
Muscle morphology
Time frame: Through study completion, an average of 1 year
Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.
Muscle stiffness
Time frame: Through study completion, an average of 1 year
Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.
Muscle vascularization
Time frame: Through study completion, an average of 1 year
Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.
Functionality 1
Time frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist.
Functionality 2
Time frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist.
Functionality 3
Time frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist.
Functionality 4
Time frame: Through study completion, an average of 1 year
One of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist.
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 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 Cerebral Palsy and Muscle Spasticity, run by Gazi University 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 2 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 6 Mar 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?
Muscle morphology (time frame: Through study completion, an average of 1 year). The study lists 7 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 6 Mar 2024.