Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke (PSAS REGISTRY)

Ipsen

Status: Completed

Conditions: Post Stroke Arm Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT02444494

A-38-52120-215

Details and patient eligibility

About

The objective of this non-interventional study is to evaluate clinical effectiveness and cost effectiveness of Dysport within the reimbursement scheme called "drug programme" funded by Polish National Health Fund (NHF) for patients with post stroke ULS. The study is designed to collect data in patients scheduled to receive Dysport treatment in a drug programme, based on routine treatment of subject with ULS.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).