Spastic HemiplegiaPhase 4NCT05615987
Comparison of Botulinum Toxin Injection Techniques in Spasticity
A Phase 4 study testing Onabotulinumtoxina for Injection in people with Spastic Hemiplegia, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spastic Hemiplegia
- What is being tested?
- Onabotulinumtoxina for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Oct 2023
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with spastic hemiplegia
- Spasticity in the gastrocnemius muscle
Who cannot join
- Those who have spasticity in other muscles that will affect ankle movements
- Those who use myorelaxant or myospasm-effective drugs
- Those who have been applied botulinum toxin in the last 3 months
- Those who have contractures in the ankle and knee due to orthopedic reasons.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Research and Training Hospital
Konya, Selçuklu, 42060
About this study
Official title: Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.
The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle.
The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection.
Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.
- Conditions
- Spastic Hemiplegia
- Being tested
- Onabotulinumtoxina for Injection
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onabotulinumtoxina for InjectionDrug
200iu/2ml in both groups
| Study group | Role | What they receive |
|---|---|---|
| Classic injection | Active comparator | 200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle Receives: Drug: Onabotulinumtoxina for Injection |
| İnjection along the length of the muscle | Experimental | A total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle Receives: Drug: Onabotulinumtoxina for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity assessment (change between pre-injection and 1-month control)
Modified ashworth scale
Measured: before injection and 1 month after injection
Spasticity assessment (change between pre-injection and 1-month control)
Tardieu scale
Measured: before injection and 1 month after injection
Spasticity assessment (change between pre-injection and 1-month control)
Joint range of motion measurement
Measured: before injection and 1 month after injection
ambulation level (change between pre-injection and 1-month control)
functional ambulation scale
Measured: before injection and 1 month after injection
ambulation velocity (change between pre-injection and 1-month control)
preferred walking speed
Measured: before injection and 1 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 posted14 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spastic HemiplegiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
- Investigators
- Savaş Karpuz, Principal investigator, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615987
- Sponsor's protocol ID
- 2022-01-14
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared if requested.
Publications
Kim MW, Kim JH, Yang YJ, Ko YJ. Anatomic localization of motor points in gastrocnemius and soleus muscles. Am J Phys Med Rehabil. 2005 Sep;84(9):680-3. doi: 10.1097/01.phm.0000176341.85398.a9.
PubMed 16141745Prodanov D, Nagelkerke N, Marani E. Spatial clustering analysis in neuroanatomy: applications of different approaches to motor nerve fiber distribution. J Neurosci Methods. 2007 Feb 15;160(1):93-108. doi: 10.1016/j.jneumeth.2006.08.017. Epub 2006 Oct 17.
PubMed 17049615Shaari CM, Sanders I. Quantifying how location and dose of botulinum toxin injections affect muscle paralysis. Muscle Nerve. 1993 Sep;16(9):964-9. doi: 10.1002/mus.880160913.
PubMed 8355728Prodanov D, Thil MA, Marani E, Delbeke J, Holsheimer J. Three-dimensional topography of the motor endplates of the rat gastrocnemius muscle. Muscle Nerve. 2005 Sep;32(3):292-302. doi: 10.1002/mus.20378.
PubMed 15948200Childers MK, Kornegay JN, Aoki R, Otaviani L, Bogan DJ, Petroski G. Evaluating motor end-plate-targeted injections of botulinum toxin type A in a canine model. Muscle Nerve. 1998 May;21(5):653-5. doi: 10.1002/(sici)1097-4598(199805)21:53.0.co;2-w.
PubMed 9572248Kaymak B, Kara M, Tok F, Ulasli AM, Ozturk GT, Chang KV, Hsiao MY, Hung CY, Yagiz On A, Ozcakar L. Sonographic guide for botulinum toxin injections of the lower limb: EUROMUSCULUS/USPRM spasticity approach. Eur J Phys Rehabil Med. 2018 Jun;54(3):486-498. doi: 10.23736/S1973-9087.17.04667-6. Epub 2017 Apr 4.
PubMed 28382814Karpuz S, Yilmaz R, Yilmaz H. Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-Blind Controlled Study. Arch Phys Med Rehabil. 2025 Mar;106(3):327-332. doi: 10.1016/j.apmr.2024.09.011. Epub 2024 Sep 27.
PubMed 39343047
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.
- ClinicalTrials.gov ID
- NCT05615987
- Acronym / sponsor ID
- 2022-01-14
- Conditions
- Spastic Hemiplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 14 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.
The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle.
The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection.
Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic injection | Active comparator | Drug: Onabotulinumtoxina for Injection200iu/2ml OnabotulinumtoxinA in total to 2-4 points proximal to the gastrocnemius muscle |
| İnjection along the length of the muscle | Experimental | Drug: Onabotulinumtoxina for InjectionA total of 200iu/2ml of onabotulinumtoxinA by spreading along the length of the gastrocnemius muscle |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with spastic hemiplegia
- Spasticity in the gastrocnemius muscle
Key exclusion criteria (4 listed)
- Those who have spasticity in other muscles that will affect ankle movements
- Those who use myorelaxant or myospasm-effective drugs
- Those who have been applied botulinum toxin in the last 3 months
- Those who have contractures in the ankle and knee due to orthopedic reasons.
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 |
|---|---|---|
| Onabotulinumtoxina for Injection200iu/2ml in both groups | Drug | Classic injection, İnjection along the length of the muscle |
Primary outcome
Spasticity assessment (change between pre-injection and 1-month control)
Time frame: before injection and 1 month after injection
Modified ashworth scale
Spasticity assessment (change between pre-injection and 1-month control)
Time frame: before injection and 1 month after injection
Tardieu scale
Spasticity assessment (change between pre-injection and 1-month control)
Time frame: before injection and 1 month after injection
Joint range of motion measurement
ambulation level (change between pre-injection and 1-month control)
Time frame: before injection and 1 month after injection
functional ambulation scale
ambulation velocity (change between pre-injection and 1-month control)
Time frame: before injection and 1 month after injection
preferred walking speed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 16141745Kim MW, Kim JH, Yang YJ, Ko YJ. Anatomic localization of motor points in gastrocnemius and soleus muscles. Am J Phys Med Rehabil. 2005 Sep;84(9):680-3. doi: 10.1097/01.phm.0000176341.85398.a9.
- Background: PubMed 17049615Prodanov D, Nagelkerke N, Marani E. Spatial clustering analysis in neuroanatomy: applications of different approaches to motor nerve fiber distribution. J Neurosci Methods. 2007 Feb 15;160(1):93-108. doi: 10.1016/j.jneumeth.2006.08.017. Epub 2006 Oct 17.
- Background: PubMed 8355728Shaari CM, Sanders I. Quantifying how location and dose of botulinum toxin injections affect muscle paralysis. Muscle Nerve. 1993 Sep;16(9):964-9. doi: 10.1002/mus.880160913.
- Background: PubMed 15948200Prodanov D, Thil MA, Marani E, Delbeke J, Holsheimer J. Three-dimensional topography of the motor endplates of the rat gastrocnemius muscle. Muscle Nerve. 2005 Sep;32(3):292-302. doi: 10.1002/mus.20378.
- Background: PubMed 9572248Childers MK, Kornegay JN, Aoki R, Otaviani L, Bogan DJ, Petroski G. Evaluating motor end-plate-targeted injections of botulinum toxin type A in a canine model. Muscle Nerve. 1998 May;21(5):653-5. doi: 10.1002/(sici)1097-4598(199805)21:53.0.co;2-w.
- Background: PubMed 28382814Kaymak B, Kara M, Tok F, Ulasli AM, Ozturk GT, Chang KV, Hsiao MY, Hung CY, Yagiz On A, Ozcakar L. Sonographic guide for botulinum toxin injections of the lower limb: EUROMUSCULUS/USPRM spasticity approach. Eur J Phys Rehabil Med. 2018 Jun;54(3):486-498. doi: 10.23736/S1973-9087.17.04667-6. Epub 2017 Apr 4.
- Derived from this study: PubMed 39343047Karpuz S, Yilmaz R, Yilmaz H. Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-Blind Controlled Study. Arch Phys Med Rehabil. 2025 Mar;106(3):327-332. doi: 10.1016/j.apmr.2024.09.011. Epub 2024 Sep 27.
- Individual participant dataSharing planned: Yes. Shared if requested.
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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.
Savaş Karpuz principal investigator
Konya Beyhekim Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Onabotulinumtoxina for Injection in people with Spastic Hemiplegia, run by Konya Beyhekim Training and Research 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 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: status not confirmed, as of the sponsor's last update on 14 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Savaş Karpuz, M.D. (+905552057860, svskrpz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity assessment (change between pre-injection and 1-month control) (time frame: before injection and 1 month after 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?
On the ClinicalTrials.gov record for NCT05615987, which also lists 7 linked publications.
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 14 Nov 2022.