Cerebral Palsy, SpasticNCT05627921
The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients
A study testing Extracorporeal Shock Wave Therapy and Botilinum Toxin injection in people with Cerebral Palsy, Spastic, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a group of movement and posture disorders associated with a non-progressive affect during brain development that can cause limitation of activity and disability. The most common movement disorders in CP are spasticity and dystonia. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- Extracorporeal Shock Wave Therapy and Botilinum Toxin injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Jul 2023
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having a diagnosis of Spastic Cerebral Palsy confirmed by a pediatric neurologist, Patients with a spasticity value of at least 2 in the evaluation with the Modified Ashworth Scale (MAS), Patients with Botulinum Toxin injection indication by their physician, Having a mental level to understand the commands of the person making the assessment, agree to participate in the study
Who cannot join
- Patients diagnosed with dyskinetic, ataxic, mixed type cerebral palsy, Hypersensitivity to Onabotulinumtoxin A or any of the excipients, Infection at the planned injection site or sites, Having an uncontrolled epileptic seizure, Upper/lower extremity contracture, coagulopathy, Refusing to participate in the study, The patient is not oriented and cooperative, Contraindication of anesthesia for the group requiring anesthesia
Trial locations and contacts
1 site in 1 country.
Evrim Karadag Saygı, Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
Nurahsen Zaben, Dr., 05453492877, nrhsn_dmr@hotmail.com
About this study
Cerebral Palsy (CP) is a group of movement and posture disorders associated with a non-progressive affect during brain development that can cause limitation of activity and disability. The most common movement disorders in CP are spasticity and dystonia. Currently, the treatment of muscle stiffness called spasticity includes physiotherapy, casting and device, various drugs and surgical treatment. Botulinum toxin injection into the muscle also acts by reducing muscle contraction. ESWT is a method used in various musculoskeletal diseases. It has been previously applied to pediatric patients and has been shown to be effective and painless in ankle muscle stiffness. However, there are few studies investigating the effect of ESWT on functionality.
Read the detailed description
Cerebral palsy (CP) is a permanent, non-progressive disorder in movement, posture, and motor development that occurs in the immature fetal or neonatal brain. Motor disturbances may be accompanied by secondary musculoskeletal problems such as spasticity and contractures. In the treatment of spasticity, various treatments such as exercise, occupational therapies, ultrasound, electrical stimulation, physiotherapy applications such as ESWT, orthoses, oral antispasticity agents, botulinum toxin injection, intrathecal baclofen, and surgery are applied. Botulinum toxin type A is one of the most widely used pharmacological treatments in the treatment of focal spasticity. Repeated injections may lead to the formation of neutralizing antibodies, resulting in a decrease in BoNT-A activity. In addition, a decrease in Botulinum toxin response may be observed due to the increase in intramuscular fat and connective tissue. In addition, in some patients with diffuse spasticity, the total dose of BoNT-A required may exceed the maximum dose. Therefore, various non-pharmacological treatment methods are recommended in addition to BoNT-A in the management of spasticity. Extracorporeal shock wave therapy (ESWT) is a treatment method for applying high pressure waves to the body. The effectiveness of ESWT on spasticity in patients with upper motor neuron damage has been demonstrated in previous studies. However, there are few studies investigating the effect of ESWT after BoNT-A injection on muscle tone, functionality and quality of life. Previous studies have shared the results of short-term follow-up after ESWT and BoNT-A injection.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- Extracorporeal Shock Wave Therapy, Botilinum Toxin injection
- Keywords
- botilinum toxin, spasticity, eswt
- 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.
Extracorporeal Shock Wave TherapyDevice
Spastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex. 1 week after the injection, patients will receive 3 sessions of radial ESWT treatment, 1 session/week. rESWT application will be applied with the 'MODUS ESWT' device and a 35 mm radial soft applicator will be used. rESWT will be applied with a soft applicator. The soft applicator is designed for application to sensitive and painful areas and applications will be painless.Shock waves will be applied at 1500/beat, 8 Hz, 0.030 Mj/mm2, 2 bar per muscle.
Botilinum Toxin injectionDrug
Spastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex.
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin group | Experimental | Not described Receives: Drug: Botilinum Toxin injection |
| botilinum toxin and ESWT group | Experimental | Not described Receives: Device: Extracorporeal Shock Wave Therapy; Drug: Botilinum Toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Tardieu Scale
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Measured: T0:Patients will be evaluated before botulinum toxin injection.
Modified Tardieu Scale
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Measured: T1:Patients will be evaluated 1 week after botulinum toxin injection.
Modified Tardieu Scale
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Measured: T2:Patients will be evaluated 1 month after botulinum toxin injection.
Modified Tardieu Scale
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Measured: T3:Patients will be evaluated 3 months after botulinum toxin injection.
Modified Tardieu Scale
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Measured: T4:Patients will be evaluated 6 months after botulinum toxin injection.
Secondary outcomes (14)
Modified Ashworth Scale
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: T0:Patients will be evaluated before botulinum toxin injection.
Modified Ashworth Scale
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: T1:Patients will be evaluated 1 week after botulinum toxin injection.
Modified Ashworth Scale
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: T2:Patients will be evaluated 1 month after botulinum toxin injection.
Modified Ashworth Scale
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: T3:Patients will be evaluated 3 months after botulinum toxin injection.
Modified Ashworth Scale
muscle tone 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Measured: T4:Patients will be evaluated 6 months after botulinum toxin injection.
Range of Motion
The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
Measured: T0:Patients will be evaluated before botulinum toxin injection.
Range of Motion
The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
Measured: T1:Patients will be evaluated 1 week after botulinum toxin injection.
Range of Motion
The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
Measured: T2:Patients will be evaluated 1 month after botulinum toxin injection.
Range of Motion
The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
Measured: T3:Patients will be evaluated 3 months after botulinum toxin injection.
Range of Motion
The joint is positioned according to the anatomical position and this position is considered as 0 starting position. Active and passive joint movement is measured with the help of a goniometer.
Measured: T4:Patients will be evaluated 6 months after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
Measured: T0:Patients will be evaluated before botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
Measured: T1:Patients will be evaluated 1 month after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
Measured: T2:Patients will be evaluated 3 months after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
The BIDA has been created to evaluate functional status, to assess therapeutic needs and changes after treatment in 2 to 18 years old children and adolescents who have orthopedic problems. The BIDAhas three forms; parent form for children, parent and self report forms for adolescents. Instrument has 86 items assessing 'upper extremity and physical function', 'transfer and basic mobility', 'sports and physical function', 'pain/comfort', 'happiness', 'global functioning' and 'expectations from treatment domains'.
Measured: T3:Patients will be evaluated 6 months after botulinum toxin injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start15 Nov 2022
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (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.
- More trials run by Marmara 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two equal groups using the closed envelope system. The patients in the first group will be injected with Botulinum Toxin-A with the Stumplex device into the spastic muscle. The patients in the second group will be injected with Botulinum toxin with the same procedure. 1 week after the injection, patients will receive 3 sessions of radial ESWT treatment, 1 session/week. rESWT application will be applied with the 'MODUS ESWT' device and a 35 mm radial soft applicator will be used.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627921
- Sponsor's protocol ID
- 09.2022.1312
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Botulinum Toxin and ESWT Applications on Spasticity and Functionality in Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT05627921
- Acronym / sponsor ID
- 09.2022.1312
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- botilinum toxin, spasticity, eswt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 28 Nov 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.
Cerebral Palsy (CP) is a group of movement and posture disorders associated with a non-progressive affect during brain development that can cause limitation of activity and disability. The most common movement disorders in CP are spasticity and dystonia. Currently, the treatment of muscle stiffness called spasticity includes physiotherapy, casting and device, various drugs and surgical treatment. Botulinum toxin injection into the muscle also acts by reducing muscle contraction. ESWT is a method used in various musculoskeletal diseases. It has been previously applied to pediatric patients and has been shown to be effective and painless in ankle muscle stiffness. However, there are few studies investigating the effect of ESWT on functionality.
Detailed description
Cerebral palsy (CP) is a permanent, non-progressive disorder in movement, posture, and motor development that occurs in the immature fetal or neonatal brain. Motor disturbances may be accompanied by secondary musculoskeletal problems such as spasticity and contractures. In the treatment of spasticity, various treatments such as exercise, occupational therapies, ultrasound, electrical stimulation, physiotherapy applications such as ESWT, orthoses, oral antispasticity agents, botulinum toxin injection, intrathecal baclofen, and surgery are applied. Botulinum toxin type A is one of the most widely used pharmacological treatments in the treatment of focal spasticity. Repeated injections may lead to the formation of neutralizing antibodies, resulting in a decrease in BoNT-A activity. In addition, a decrease in Botulinum toxin response may be observed due to the increase in intramuscular fat and connective tissue. In addition, in some patients with diffuse spasticity, the total dose of BoNT-A required may exceed the maximum dose. Therefore, various non-pharmacological treatment methods are recommended in addition to BoNT-A in the management of spasticity. Extracorporeal shock wave therapy (ESWT) is a treatment method for applying high pressure waves to the body. The effectiveness of ESWT on spasticity in patients with upper motor neuron damage has been demonstrated in previous studies. However, there are few studies investigating the effect of ESWT after BoNT-A injection on muscle tone, functionality and quality of life. Previous studies have shared the results of short-term follow-up after ESWT and BoNT-A injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two equal groups using the closed envelope system. The patients in the first group will be injected with Botulinum Toxin-A with the Stumplex device into the spastic muscle. The patients in the second group will be injected with Botulinum toxin with the same procedure. 1 week after the injection, patients will receive 3 sessions of radial ESWT treatment, 1 session/week. rESWT application will be applied with the 'MODUS ESWT' device and a 35 mm radial soft applicator will be used.
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin group | Experimental | Drug: Botilinum Toxin injection |
| botilinum toxin and ESWT group | Experimental | Device: Extracorporeal Shock Wave Therapy, Drug: Botilinum Toxin injection |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Having a diagnosis of Spastic Cerebral Palsy confirmed by a pediatric neurologist, Patients with a spasticity value of at least 2 in the evaluation with the Modified Ashworth Scale (MAS), Patients with Botulinum Toxin injection indication by their physician, Having a mental level to understand the commands of the person making the assessment, agree to participate in the study
Key exclusion criteria (1 listed)
- Patients diagnosed with dyskinetic, ataxic, mixed type cerebral palsy, Hypersensitivity to Onabotulinumtoxin A or any of the excipients, Infection at the planned injection site or sites, Having an uncontrolled epileptic seizure, Upper/lower extremity contracture, coagulopathy, Refusing to participate in the study, The patient is not oriented and cooperative, Contraindication of anesthesia for the group requiring anesthesia
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 |
|---|---|---|
| Extracorporeal Shock Wave TherapySpastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex. 1 week after the injection, patients will receive 3 sessions of radial ESWT treatment, 1 session/week. rESWT application will be applied with the 'MODUS ESWT' device and a 35 mm radial soft applicator will be used. rESWT will be applied with a soft applicator. The soft applicator is designed for application to sensitive and painful areas and applications will be painless.Shock waves will be applied at 1500/beat, 8 Hz, 0.030 Mj/mm2, 2 bar per muscle. | Device | botilinum toxin and ESWT group |
| Botilinum Toxin injectionSpastic muscles will be determined by examination. Botulinum toxin-A will be injected into the spastic muscles with Stumplex. | Drug | botilinum toxin and ESWT group, botulinum toxin group |
Primary outcome
Modified Tardieu Scale
Time frame: T0:Patients will be evaluated before botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Modified Tardieu Scale
Time frame: T1:Patients will be evaluated 1 week after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Modified Tardieu Scale
Time frame: T2:Patients will be evaluated 1 month after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Modified Tardieu Scale
Time frame: T3:Patients will be evaluated 3 months after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
Modified Tardieu Scale
Time frame: T4:Patients will be evaluated 6 months after botulinum toxin injection.
The intensity of muscle tone is evaluated at different determined rates. At the joint, the first angle at which the increase in resistance is detected is recorded. The range of motion is compared to the angle at completion.
14 secondary outcomes
Modified Ashworth Scale
Time frame: T0:Patients will be evaluated before botulinum toxin injection.
Modified Ashworth Scale
Time frame: T1:Patients will be evaluated 1 week after botulinum toxin injection.
Modified Ashworth Scale
Time frame: T2:Patients will be evaluated 1 month after botulinum toxin injection.
Modified Ashworth Scale
Time frame: T3:Patients will be evaluated 3 months after botulinum toxin injection.
Modified Ashworth Scale
Time frame: T4:Patients will be evaluated 6 months after botulinum toxin injection.
Range of Motion
Time frame: T0:Patients will be evaluated before botulinum toxin injection.
Range of Motion
Time frame: T1:Patients will be evaluated 1 week after botulinum toxin injection.
Range of Motion
Time frame: T2:Patients will be evaluated 1 month after botulinum toxin injection.
Range of Motion
Time frame: T3:Patients will be evaluated 3 months after botulinum toxin injection.
Range of Motion
Time frame: T4:Patients will be evaluated 6 months after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
Time frame: T0:Patients will be evaluated before botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
Time frame: T1:Patients will be evaluated 1 month after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
Time frame: T2:Patients will be evaluated 3 months after botulinum toxin injection.
BIDA( Bodily Functioning Assessment Tool)
Time frame: T3:Patients will be evaluated 6 months after botulinum toxin injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- 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. This study is not recruiting at the moment.
Evrim Karadag Saygı, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy and Botilinum Toxin injection in people with Cerebral Palsy, Spastic, run by Marmara 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurahsen Zaben, Dr (05453492877, nrhsn_dmr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Tardieu Scale (time frame: T0:Patients will be evaluated before botulinum toxin injection.). The study lists 5 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 28 Nov 2022.