Cerebral Palsy, SpasticNCT06494618
Effects of Botulinum Toxin Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
A study testing Radial Extracorporeal Shockwave Therapy in people with Cerebral Palsy, Spastic, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Radial Extracorporeal Shockwave Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with cerebral palsy.
- Spasticity in at least one of the lower extremity muscle groups.
- No contraindications to shockwave therapy.
- Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity.
- Agreed to participate to study (patient/primary caregiver)
Who cannot join
- Surgery history within the last year of the muscle to be injected and treated
- Having uncontrolled epilepsy.
- Having infection
- Coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Kadikoy, 34722
Ismail Hakan Akbulut, Resident, +905549151240, hakan__akbulut@hotmail.com
Belgin Erhan, Assoc. Prof., +905322678024, dr.belginerhan@gmail.com
About this study
Official title: The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy
Read the detailed description
20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Radial Extracorporeal Shockwave Therapy
- Keywords
- cerebral palsy, spasticity, botulinum toxin injection, extracorporeal shockwave therapy
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shockwave TherapyDevice
1500 pulses, 4 hertz, 2 bar radial extracorporeal shockwave therapy targeted muscle belly for botulinum toxin injected lower extremity muscle groups. 3 sessions were planned once a week, starting from first week after injection.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Injection and Conventional Therapy | No intervention | The group received conventional therapy (such as stretching exercises) after Botulinum Toxin Type A Injection for spastic lower extremity muscle groups. |
| Botulinum Toxin Injection and Shockwave Therapy | Active comparator | The group received extracorporeal shockwave therapy conventional therapy (such as stretching exercises). Shockwave therapy is planned 3 sessions, starting first week after injection. It is planned to apply 1500 pulses, 4 hertz, 2 bars radial eswt to the injected spastic muscle groups in each session. The patients in this group will continue to their conventional therapy like the first group. Receives: Device: Radial Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Aschworth Scale
Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.
Measured: 3 months (before injection, first week, first month and third month after injection.)
Modified Tradiue Scale
Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.
Measured: 3 months (before injection, first week, first month and third month after injection.)
Modified Timed Up and Go Test
The test for evaluate the functionality of pediatric patients with cerebral palsy. Only one chair and a surface for the patient to walk three meters are required. The time it takes for the patient to get up from the chair, walk the specified distance and sit back in the chair is recorded.
Measured: 3 months (before injection, first week, first month and third month after injection.
Facies Pain Scale Revised
The scale for evaluate the pain level of pediatric patients. Chosen faces are scored 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."
Measured: 3 months (before injection, first week, first month and third month after injection.)
Passive Range of Motion
Goniometric measurement of the range of motion of the joint of the injected muscle
Measured: 3 months (before injection, first week, first month and third month after injection.)
Goal Attaintment Scale
The method of scoring the extent to which patient's individual goals are achieved in the course of intervention. GAS comprises of goals divided into a 5-point scale from -2 to +2.
Achievement of goal = 0 Achieved somewhat more than expected outcome = +1 Achievement of much more than expected goal = +2 Achievement of somewhat less than expected goal = -1 Achievement of much less than expected goal = -2
Measured: 3 months (before injection, first week, first month and third month after injection.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startMar 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pediatric patients diagnosed with cerebral palsy who received botulinum toxin injection for lower extremity spasticity were randomized two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles and their routine conventional therapy. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
- Investigators
- Belgin Erhan, Assoc. Prof., Study director, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494618
- Sponsor's protocol ID
- CP BTX ESWT
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06494618
- Acronym / sponsor ID
- CP BTX ESWT
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- cerebral palsy, spasticity, botulinum toxin injection, extracorporeal shockwave therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Jul 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.
This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy
Detailed description
20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pediatric patients diagnosed with cerebral palsy who received botulinum toxin injection for lower extremity spasticity were randomized two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles and their routine conventional therapy. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Injection and Conventional Therapy | No intervention | –The group received conventional therapy (such as stretching exercises) after Botulinum Toxin Type A Injection for spastic lower extremity muscle groups. |
| Botulinum Toxin Injection and Shockwave Therapy | Active comparator | Device: Radial Extracorporeal Shockwave TherapyThe group received extracorporeal shockwave therapy conventional therapy (such as stretching exercises). Shockwave therapy is planned 3 sessions, starting first week after injection. It is planned to apply 1500 pulses, 4 hertz, 2 bars radial eswt to the injected spastic muscle groups in each session. The patients in this group will continue to their conventional therapy like the first group. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with cerebral palsy.
- Spasticity in at least one of the lower extremity muscle groups.
- No contraindications to shockwave therapy.
- Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity.
- Agreed to participate to study (patient/primary caregiver)
Key exclusion criteria (4 listed)
- Surgery history within the last year of the muscle to be injected and treated
- Having uncontrolled epilepsy.
- Having infection
- Coagulopathy
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 |
|---|---|---|
| Radial Extracorporeal Shockwave Therapy1500 pulses, 4 hertz, 2 bar radial extracorporeal shockwave therapy targeted muscle belly for botulinum toxin injected lower extremity muscle groups. 3 sessions were planned once a week, starting from first week after injection. | Device | Botulinum Toxin Injection and Shockwave Therapy |
Primary outcome
Modified Aschworth Scale
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.
Modified Tradiue Scale
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.
Modified Timed Up and Go Test
Time frame: 3 months (before injection, first week, first month and third month after injection.
The test for evaluate the functionality of pediatric patients with cerebral palsy. Only one chair and a surface for the patient to walk three meters are required. The time it takes for the patient to get up from the chair, walk the specified distance and sit back in the chair is recorded.
Facies Pain Scale Revised
Time frame: 3 months (before injection, first week, first month and third month after injection.)
The scale for evaluate the pain level of pediatric patients. Chosen faces are scored 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."
Passive Range of Motion
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Goniometric measurement of the range of motion of the joint of the injected muscle
Goal Attaintment Scale
Time frame: 3 months (before injection, first week, first month and third month after injection.)
The method of scoring the extent to which patient's individual goals are achieved in the course of intervention. GAS comprises of goals divided into a 5-point scale from -2 to +2. Achievement of goal = 0 Achieved somewhat more than expected outcome = +1 Achievement of much more than expected goal = +2 Achievement of somewhat less than expected goal = -1 Achievement of much less than expected goal = -2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- 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.
Belgin Erhan, Assoc. Prof. study director
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shockwave Therapy in people with Cerebral Palsy, Spastic, run by Istanbul Medeniyet 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 5 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismail Hakan Akbulut, Resident (+905549151240, hakan__akbulut@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Aschworth Scale (time frame: 3 months (before injection, first week, first month and third month after injection.)). The study lists 6 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 11 Mar 2025.