Spastic HemiplegiaNCT07482618
Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection
An observational study of Spastic Hemiplegia, run by Ayse Guc at 1 site in Turkey (Türkiye).
Trial summary
Tolperison is an antispastic agent used in the treatment of spasticity. Studies on tolperison are limited, and the literature on its effectiveness against spasticity and neuropathic pain is also limited. Read more about this study
- Who is it for?
- Ages 18 to 80 months
- Conditions the study is for
- Spastic Hemiplegia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2025to 10 Jul 2026
- How long will I take part?
- 120 Days
- Phase
- Observational
- 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 18 to 80 months
- All sexes
- No healthy volunteers
- Child
Study population: Hemiplegia Patients Hospitalized at Kayseri City Hospital
Who may be able to join
- Ability to stand
- History of previous hemorrhagic or ischemic stroke
- Stroke-related spasticity (MAS ≥2)
- Men and women aged 18-80 years
- Agreement to participate in the study
Who cannot join
- Diabetes patients
- people who have undergone orthopedic surgery
- Individuals with non-stroke neurological diseases
- Those receiving oral antispastic treatment (non-tolperison medications)
- Those who have undergone surgery for spasticity
- Individuals lacking orientation and cooperation
Show all 11Show fewer
- Those undergoing surgery, such as with intrathecal baclofen
- Individuals receiving medical treatment for neuropathic pain
- Individuals under 18 and over 80 years of age
- History of allergy or hypersensitivity to the medication to be used
- Presence of a fixed contracture in the affected extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital Physical Medicine and Rehabilitation
Kayseri, Kocasinan
About this study
Official title: Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection: A Controlled Study
Tolperison is an antispastic agent used in the treatment of spasticity. Studies on tolperison are limited, and the literature on its effectiveness against spasticity and neuropathic pain is also limited.
Read the detailed description
Botulinum toxin injection is the most commonly used antispastic agent in the treatment of regional spasticity in hemiplegia patients. Both botulinum toxin injections and oral antispastic agents are widely used. Many studies have shown that botulinum toxin injection is more effective in treating regional spasticity. Because botulinum toxin injection is more frequently preferred, the study included patients who received botulinum toxin injections. Patients receiving botulinum toxin injections benefit from the injection, but in some patients, the injection is insufficient. Additionally, oral antispastic agents such as baclofen, tizanidine, and tolperisone are also added to the treatment. Reimbursement for tolperisone for hemiplegia patients has recently begun. It is covered by the Social Security Institution (SGK), but it is not a widely used drug. The researcher will screen patients diagnosed with hemiplegia who have been initiated with daily botulinum toxin injections (+/- tolperison). Patients will be followed prospectively. Patients prescribed tolperison will be examined before receiving the medication, and post-treatment follow-ups will be evaluated using questionnaires. The aim was to observe whether tolperison makes a difference between the groups. Patients in the botulinum toxin injection group will be followed before and after the injection. The aim of this study is to examine the effectiveness of tolperison in antispasticity and neuropathic pain.
- Conditions
- Spastic Hemiplegia
- Keywords
- spasticity, hemiplegia, tolperison, neuropatric pain
- Medical subject headings
- Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Group | This group consisted only of patients who received Botulinum injections. Tolperison treatment was not initiated in this group. | |
| Botulinum Toxin and Tolperison Group | Patients who started oral tolperison treatment in addition to botulinum toxin injection. Tolperison was administered at standard clinical doses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale(MAS)
Spasticity severity will be assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive soft-tissue stretching and is graded on a 6-point scale (0, 1, 1+, 2, 3, 4). Higher scores indicate greater spasticity. Measurements will be recorded before botulinum toxin injection and during follow-up visits.
Measured: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.
Douleur Neuropathique 4 (DN4)
Neuropathic pain will be evaluated using the Douleur Neuropathique 4 (DN4) questionnaire.The DN4 consists of 10 items assessing neuropathic pain symptoms and sensory examination findings. Each item is scored as 0 (no) or 1 (yes). A total score ≥4 indicates neuropathic pain.
Measured: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.
Secondary outcomes (1)
Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
Walking ability will be evaluated using the 10-Meter Walk Test. Participants will be asked to walk a distance of 10 meters at their comfortable walking speed. Walking speed will be calculated in meters per second.
Measured: Time Frame: Baseline (Day 0), Day 15, Month 1, and Month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 Aug 2025
- Primary completion25 May 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 120 Days
Sponsor and investigators
- Lead sponsor
- Ayse Guc
- Sponsor type
- Other government
- Collaborators
- Kayseri City Hospital
- Responsible party
- Sponsor-investigator, Ayse Guc, Kayseri City Hospital
- Investigators
- Melike Yavuz, Principal investigator, Kayseri City Hospital Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482618
- Sponsor's protocol ID
- 482
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data obtained within the scope of this study are not planned to be shared. Data sharing is restricted due to patient privacy, ethics committee approvals, and current data protection legislation.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection: A Controlled Study
- ClinicalTrials.gov ID
- NCT07482618
- Acronym / sponsor ID
- 482
- Conditions
- Spastic Hemiplegia
- Keywords
- spasticity, hemiplegia, tolperison, neuropatric pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ayse GucOther government
- Collaborators
- Kayseri City Hospital
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
Tolperison is an antispastic agent used in the treatment of spasticity. Studies on tolperison are limited, and the literature on its effectiveness against spasticity and neuropathic pain is also limited.
Detailed description
Botulinum toxin injection is the most commonly used antispastic agent in the treatment of regional spasticity in hemiplegia patients. Both botulinum toxin injections and oral antispastic agents are widely used. Many studies have shown that botulinum toxin injection is more effective in treating regional spasticity. Because botulinum toxin injection is more frequently preferred, the study included patients who received botulinum toxin injections. Patients receiving botulinum toxin injections benefit from the injection, but in some patients, the injection is insufficient. Additionally, oral antispastic agents such as baclofen, tizanidine, and tolperisone are also added to the treatment. Reimbursement for tolperisone for hemiplegia patients has recently begun. It is covered by the Social Security Institution (SGK), but it is not a widely used drug. The researcher will screen patients diagnosed with hemiplegia who have been initiated with daily botulinum toxin injections (+/- tolperison). Patients will be followed prospectively. Patients prescribed tolperison will be examined before receiving the medication, and post-treatment follow-ups will be evaluated using questionnaires. The aim was to observe whether tolperison makes a difference between the groups. Patients in the botulinum toxin injection group will be followed before and after the injection. The aim of this study is to examine the effectiveness of tolperison in antispasticity and neuropathic pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 120 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Group | – | –This group consisted only of patients who received Botulinum injections. Tolperison treatment was not initiated in this group. |
| Botulinum Toxin and Tolperison Group | – | –Patients who started oral tolperison treatment in addition to botulinum toxin injection. Tolperison was administered at standard clinical doses. |
Who may qualify
- Ages
- 18 to 80 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hemiplegia Patients Hospitalized at Kayseri City Hospital
Key inclusion criteria (5 listed)
- Ability to stand
- History of previous hemorrhagic or ischemic stroke
- Stroke-related spasticity (MAS ≥2)
- Men and women aged 18-80 years
- Agreement to participate in the study
Key exclusion criteria (11 listed)
- Diabetes patients
- people who have undergone orthopedic surgery
- Individuals with non-stroke neurological diseases
- Those receiving oral antispastic treatment (non-tolperison medications)
- Those who have undergone surgery for spasticity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Ashworth Scale(MAS)
Time frame: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.
Spasticity severity will be assessed using the Modified Ashworth Scale (MAS). The MAS evaluates resistance during passive soft-tissue stretching and is graded on a 6-point scale (0, 1, 1+, 2, 3, 4). Higher scores indicate greater spasticity. Measurements will be recorded before botulinum toxin injection and during follow-up visits.
Douleur Neuropathique 4 (DN4)
Time frame: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.
Neuropathic pain will be evaluated using the Douleur Neuropathique 4 (DN4) questionnaire.The DN4 consists of 10 items assessing neuropathic pain symptoms and sensory examination findings. Each item is scored as 0 (no) or 1 (yes). A total score ≥4 indicates neuropathic pain.
1 secondary outcome
Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
Time frame: Time Frame: Baseline (Day 0), Day 15, Month 1, and Month 3.
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 20 Mar 2026.
- Individual participant dataSharing planned: No. Individual patient data obtained within the scope of this study are not planned to be shared. Data sharing is restricted due to patient privacy, ethics committee approvals, and current data protection legislation.
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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.
Melike Yavuz principal investigator
Kayseri City Hospital Physical Medicine and Rehabilitation
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 Spastic Hemiplegia, run by Ayse Guc 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 11 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. 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?
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?
Modified Ashworth Scale(MAS) (time frame: Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.). The study lists 2 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 20 Mar 2026.