Post-Stroke Chronic Upper Limb Spasticity
Conditions
Brief summary
The purpose of this study is to collect data for Dysport® SMART BoNT-A therapy usage in an office-based setting in post-stroke participants with chronic (\> 6 months) focal Upper Limb Spasticity who have been under stable oral antispastics treatment or patients with no current anti-spasticity treatment.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients ≥18 years with the capacity to consent. * Subjects with a post-stroke medium to severe focal upper limb spasticity for at least 6 months. Medium to severe focal upper limb spasticity is defined as MAS ≥2 in the PTMG and DAS ≥2 in the PTT. * Cohort according to SMART guidelines. The SMART injection concept is designed to be used only in patients suffering from simple patterns (easy to diagnose spasticity pattern) of adult ULS, where Abobotulinumtoxin-A (AboBoNT-A) (Dysport®) injection can be simplified, by recognizing common spasticity patterns and key muscles for injection, identifying those muscles by palpation, and appropriate injection points of the suggested muscles using anatomic landmarks. * Subjects with treatment goals as reduction of pain, reduction of muscle tone, improvement of care (hygiene/dressing) and/or improvement of passive motion. * Subjects with the intention to be treated with Dysport® according to the current local Summary of Product Characteristics (SmPC) (Germany) and injection according to SMART must be taken prior to the entry in the study. * Physiotherapy should remain unchanged within 4 weeks before study start.
Exclusion criteria
* Patients treated with intrathecal Baclofen or BoNT-A within the last 6 months * If treated with oral spasticity medication, change of oral spasticity medication within the last 4 weeks * Patients with active hand functions or patients with treatment goals of active functions. * Patients with any contraindication for Dysport® according to SmPC. * Patients in whom SMART therapy is not appropriate (e.g. spasticity pattern other than specified in SMART guidelines). * Participation in an interventional trial at the same time and/or within 3 months before baseline. * Diagnosed contracture/contracted muscle.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Disability Assessment Scale (DAS) score in Principle Target of Treatment (PTT) for the upper limb. | At 12 weeks to 16 weeks after injection at Visit 1 | The PTT will be pre-selected from the 4 DAS domains: hygiene, dressing, limb position and pain of the upper limb at Visit 1. The extent of functional impairment in the PTT will be assessed on a four-point scale (range 0 to 3, where 0=no disability, and 3=severe disability) at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Modified Ashworth Scale (MAS) Primary Target Muscle Group (PTMG) | At 12 weeks to 16 weeks | Muscle tone will be evaluated using the MAS. The PTMG (shoulder adductors, elbow flexors, wrist flexors or finger flexors) will be pre-selected at Visit 1. The muscle tone in the PTMG will be assessed from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension) at each visit. |
| Change from baseline of pain assessed with Visual Analogue Scale (VAS) | At 12 weeks to 16 weeks | Pain (from 0 (no pain) to 10 (maximum pain) in upper limb extremity will be assessed at each visit. |
| Change from baseline of Spasticity Related Quality of Life Tool (SQoL-6D) | At 12 weeks to 16 weeks | The questionnaire covers six dimensions: Pain/ discomfort, involuntary movement or spasms, restricted range of movement, caring for the affected limb, using the affected limb, mobility/balance. Each dimension is assessed using a five-point scale ranging from 0 to 4, with higher scores meaning worse outcome. |
| Incidence of Adverse Events (AEs) | Up to 32 weeks | — |
| Incidence of Special Situations (SS) | Up to 32 weeks | — |
Countries
Germany
Outcome results
None listed