Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT02444494
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age.
* A history of ischemic or haemorrhagic stroke before minimum 3 months prior to the inclusion into drug programme, documented by discharge from the hospital.
* Post-stroke spasticity of confirmed upper extremity moderate or higher (the result of the modified Ashworth scale - MAS ≥ 2) in at least one muscle group.
* Classification of the patient into the programme occurs when a patient has a designated date of commencement of medical rehabilitation confirmed by the providing rehabilitation services.
* Drug administration needs to take place no earlier than three weeks before the start of medical rehabilitation.
* Written informed consent given by patient before any occurrence of study related procedure.
* Patient has been already included in a NHF Dysport programme.
Exclusion Criteria:
* Severe dysphagia and respiratory disorders.
* Pregnancy
* Myasthenia gravis and myasthenic syndrome - based on neurological examination (additional tests only in justified cases).
* Generalized symptoms of infection
* The presence of inflammation within the planned sites of administration.
* Fixed contractures in the soft tissues and joints.
* Dementia medium or deep cycle (score on mini mental state examination (MMSE) equal to or less than 18 points).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02444494
Study Brief:
Protocol Section:
NCT02444494