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

Study Overview
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Brief Summary
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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.

Official Title
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ETREAT: A Prospective Observational Study to Evaluate the Effectiveness of Botulinum Toxin Type A (BoNT-A) Injections in Patients With Post-stroke Upper and/or Lower Limb Spasticity in the Early Stage of Spasticity Development.

Conditions
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Spasticity

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Goal Attainment Scale (GAS) score. |  | Baseline, 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, 16 months | 
| Change in Modified Ashworth Scale (MAS) score. |  | Baseline, 16 months | 
| Baseline characteristics of patients | Demographic characteristics | Baseline | 
| Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score. |  | From baseline up to 16 months | 
| Change in pain according to Visual Analog Scale (VAS). |  | Baseline, 16 months | 
| Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS). |  | Baseline, 16 months | 
| Comfortable barefoot walking speed, measured with the 10-meter walking speed test. |  | Baseline, 16 months | 
| Change on EQ-5D quality of life questionnaire |  | Baseline, 16 months | 
| Estimation of use of healthcare resources and costs associated with management of spasticity. |  | From baseline up to 16 months | 
| Time interval between injections |  | From baseline up to 16 months | 
| Cost per patient |  | From baseline up to 16 months |