Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm

Ipsen96 enrolled

Overview

The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cerebrovascular Accident Muscle Spasticity

Interventions

Botulinum toxin type ABIOLOGICAL

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously. * The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale. * The patient has the cognitive and communication ability to participate in the study. Exclusion Criteria: * Patients who have received botulinum toxin treatment within the past 120 days. * Contraindication to botulinum toxin treatment. * Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry. * Patients who have previously been treated with phenol for their upper limb spasticity.

Locations (6)

St Josephs Hospital

Auburn, New South Wales, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Outcomes

Primary Outcomes

Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).

Secondary Outcomes

Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)

Change in the Modified Motor Assessment Scale

Change in patient disability and carer burden rating scale total score

Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)

Change in the degree of pain

Change in depression rating scale total score

Global assessment of benefit

Data from ClinicalTrials.gov

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