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

Observational Prospective Study to Document the Effectiveness of Dysport in Patients Suffering From Upper Limb Spasticity (ULS) After Stroke, Under Conditions of Routine Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Post Stroke Arm Spasticity

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Poland
  • Ciecierzyn, Poland, 21-003
    • Indywidualna Praktyka Lekarska
  • Katowice, Poland, 40-752, ul Medyków 14
    • Samodzielny Publiczny Centralny Szpital Kliniczny im, Śląskiego Uniwersytetu Medycznego w Katowicach Oddział Neurologii Wieku Podeszłego
  • Sandomierz, Poland, 27-600 Schinzla 13
    • Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Sandomierzu - Szpital - Oddział Neurologii z Pododdziałem Udarowym
  • Szczecin, Poland, Chopina 22, 71-450
    • Indywidualna Specjalistyczna Praktyka Lekarska W Zakresie Neurologii
  • Warsaw, Poland, Sobieskiego 9, 02-957
    • II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii
  • Wrocław, Poland, 51-149 KOSZAROWA 5
    • Wojewódzki Szpital Specjalistyczny Im.J.Gromkowskiego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from post-stroke arm spasticity and scheduled to receive injection of Dysport in post stroke upper limb spasticity drug programme.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Investigator and patient Clinical Global Impression of Improvement (CGI-I)	Clinical Global Impression of Improvement (CGI-I) scale: 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change.	Change from baseline (visit 1) to visit 3 (visits occur every 3-4 months, during approximately 9 months of observation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global assessment of spasticity by Modified Ashworth Scale (MAS)	MAS - spasticity scores at each joint: shoulder, elbow, wrist, finger, thumb	Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
Measurement of upper limb muscle weakness by Medical Research Council (modified MRC) scale for muscle strength		Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)
To document cost of treatment with Dysport in these patients	Direct costs associated with the administration of Dysport will include the dose of Dysport, interval between reinjections, cost of healthcare resources: needles, syringes, identification techniques of the muscles.	Visits 1, 2 and 3 (visits occur every 3-4 months, during approximately 9 months of observation)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 11, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: A-38-52120-215