Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:03 PM
Study NCT ID:
NCT07482618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '120 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Ashworth Scale(MAS)', 'timeFrame': 'Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.', 'description': '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.'}, {'measure': 'Douleur Neuropathique 4 (DN4)', 'timeFrame': 'Time Frame: Baseline (Day O), Day 15, Month 1, and Month 3.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Walking Speed Assessed by the 10-Meter Walk Test (10MWT)', 'timeFrame': 'Time Frame: Baseline (Day 0), Day 15, Month 1, and Month 3.', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spasticity', 'hemiplegia', 'tolperison', 'neuropatric pain'], 'conditions': ['Spastic Hemiplegia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '80 Months', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemiplegia Patients Hospitalized at Kayseri City Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to stand\n* History of previous hemorrhagic or ischemic stroke\n* Stroke-related spasticity (MAS ≥2)\n* Men and women aged 18-80 years\n* Agreement to participate in the study\n\nExclusion Criteria:\n\n* Diabetes patients\n* people who have undergone orthopedic surgery\n* Individuals with non-stroke neurological diseases\n* Those receiving oral antispastic treatment (non-tolperison medications)\n* Those who have undergone surgery for spasticity\n* Individuals lacking orientation and cooperation\n* Those undergoing surgery, such as with intrathecal baclofen\n* Individuals receiving medical treatment for neuropathic pain\n* Individuals under 18 and over 80 years of age\n* History of allergy or hypersensitivity to the medication to be used\n* Presence of a fixed contracture in the affected extremity'}, 'identificationModule': {'nctId': 'NCT07482618', 'briefTitle': 'Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri City Hospital'}, 'officialTitle': 'Evaluation of Spasticity, Neuropathic Pain, and Gait Analysis in Stroke Patients Receiving Tolperison Therapy After Botulinum Toxin Injection: A Controlled Study', 'orgStudyIdInfo': {'id': '482'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Botulinum Toxin Group', 'description': 'This group consisted only of patients who received Botulinum injections. Tolperison treatment was not initiated in this group.'}, {'label': 'Botulinum Toxin and Tolperison Group', 'description': 'Patients who started oral tolperison treatment in addition to botulinum toxin injection. Tolperison was administered at standard clinical doses.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayseri', 'state': 'Kocasinan', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri City Hospital Physical Medicine and Rehabilitation', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Melike Yavuz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri City Hospital Physical Medicine and Rehabilitation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayse Guc', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Kayseri City Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'UZMAN DOCTOR', 'investigatorFullName': 'Ayse Guc', 'investigatorAffiliation': 'Kayseri City Hospital'}}}}