ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity

Ipsen110 enrolled

Overview

The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Spasticity

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women ≥ 18-80 years. * Poststroke limb spasticity. * Patients who have suffered a stroke in the previous 6 months. * Treatment goal has been previously agreed with the patient or their legal representative. * Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation. * No previous treatment with BoNT-A. * Patient is able to follow the protocol. * Written informed consent. Exclusion Criteria: * Neuromuscular disease. * Use of drugs that interfere with neuromuscular transmission. * Any other condition that could interfere with rehabilitation or evaluation of the results. * Diagnosis of spasticity not associated with stroke. * Pregnant or nursing mothers. * Prior participation in any other study in the 6 months before study entry

Locations (17)

Unnamed facility

Barcelona, Spain

Unnamed facility

Bilbao, Spain

Unnamed facility

Cadiz, Spain

Unnamed facility

Outcomes

Primary Outcomes

Change in Goal Attainment Scale (GAS) score.

Time frame: Baseline, 16 months

Secondary Outcomes

Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke

Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages

Time frame: Baseline, 16 months

Change in Modified Ashworth Scale (MAS) score.

Time frame: Baseline, 16 months

Baseline characteristics of patients

Demographic characteristics

Time frame: Baseline

Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.

Time frame: From baseline up to 16 months

Change in pain according to Visual Analog Scale (VAS).

Time frame: Baseline, 16 months

Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).

Time frame: Baseline, 16 months

Comfortable barefoot walking speed, measured with the 10-meter walking speed test.

Time frame: Baseline, 16 months

Change on EQ-5D quality of life questionnaire

Time frame: Baseline, 16 months

Estimation of use of healthcare resources and costs associated with management of spasticity.

Data from ClinicalTrials.gov

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