Spasticity
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Goal Attainment Scale (GAS) score. | Baseline, 16 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost per patient | From baseline up to 16 months | — |
| Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke | Baseline, 16 months | Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages |
| Change in Modified Ashworth Scale (MAS) score. | Baseline, 16 months | — |
| Baseline characteristics of patients | Baseline | Demographic characteristics |
| Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score. | From baseline up to 16 months | — |
| Time interval between injections | From baseline up to 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 | — |
| Change in pain according to Visual Analog Scale (VAS). | Baseline, 16 months | — |
Countries
Spain
Outcome results
None listed