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Clinical Trials in Turkey / NCT07482618
Active, not recruiting Observational

Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection

NCT07482618 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ayse Guc
Phase
Observational
Started
2025-08-13
Last updated
2026-03-20

Condition(s) studied

Spastic Hemiplegia

Study 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.

Eligibility

Sex
ALL
Min age
18 Months
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Kayseri City Hospital Physical Medicine and Rehabilitation Kayseri Kocasinan

Other trials for the same condition

Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07482618 on ClinicalTrials.gov ↗ ← All trials in Turkey