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

NCT07482618 | Active Not Recruiting DMC

• 1 other identifier: 482
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Hemiplegia

Keywords

spasticity; hemiplegia; tolperison; neuropatric pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Time Frame: Baseline (Day 0), Day 15, Month 1, and Month 3.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Months - 80 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hemiplegia Patients Hospitalized at Kayseri City Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayse Guc: lead
• Kayseri City Hospital: collaborator

Study Sites (1)

Kayseri City Hospital Physical Medicine and Rehabilitation

Kayseri, Kocasinan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Melike Yavuz

  Kayseri City Hospital Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 120 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: UZMAN DOCTOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: March 19, 2026
• Study Start: August 13, 2025
• Primary Completion: May 25, 2026
• Study Completion: July 10, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)