Spastic Hemiplegia
Conditions
Keywords
spasticity, hemiplegia, tolperison, neuropatric pain
Brief 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.
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.
Interventions
None listed
Sponsors
Ayse Guc
Kayseri City Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Months to 80 Months
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale(MAS) | 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: 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed Assessed by the 10-Meter Walk Test (10MWT) | Time Frame: Baseline (Day 0), Day 15, Month 1, and Month 3. | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMelike Yavuz
Kayseri City Hospital Physical Medicine and Rehabilitation
Outcome results
None listed