Spasticity as Sequela of Stroke
Conditions
Keywords
Botulinum neurotoxin type A (BoNT-A), Stroke, Rehabilitation, Post-Stroke Spasticity (PSS)
Brief summary
Stroke is one of the leading cause of death and disability worldwide. Post-stroke spasticity (PSS) is outbreak after a stroke and is featured by disabling muscle stiffness. PSS could manifest in up tp 50% cases within 6 months after a stroke, especially in the upper limb. Despite it is an acknowledged condition it is insufficiently recognized and treated in clinical practice. Focal and regional spasticity could improve with rehabilitation and in selected cases with botulinum neurotoxin (BoNT) type A injections. The latter causes muscle relaxation and fosters neuroplasticity, which is able in turn of ameliorating several patient functional aspects. Recent literature demonstrated that PSS patients treated with early BoNT (within 3 month since PSS outbreak) could improve in their clinical status better than patients with a later treatment. An earlier recognition of PSS predictors could improve patient management. Hence, the investigators are going to perform a multicentric prospective observational real life study with BoNT, based on the best clinical practice and aimed at the early recognition and management of PSS through the identification of 1) early clinical predictors of spasticity (collected within 10 days since stroke), 2) BoNT clinical outcome relative to the timing of the treatment
Interventions
DRUGBotulinum toxin type A
Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A
Sponsors
Campus Bio-Medico University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Ischemic stroke with onset not far than 10 days before the enrollment * BoNT naive * Ability to sign the informed consent
Exclusion criteria
* Hypersensitivity to BoNT or BoNT related substances * Participant of Post-stroke spasticity RCT * Persistent and severe altered mental status or concurrent severe medical condition able to hasten the rehabilitation path.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper limb post stroke-spasticity development | 0-24 months | Detection of a Modified Ashworth Scale (MAS) \>/= 1 at the upper limb (MAS is a 0 to 5 score, with score 5 as the worst rigidity possible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Stroke Spasticity in early vs late treatment | 3-24 months | Comparison of the Modified Ashworth Scale (MAS) at the elbow and wrist (MAS is a 0 to 5 score, with score 5 as the worst rigidity possible) in early versus late treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain measurement | 3-24 months | Comparison of pain (Visual Analogue scale or VAS in units on a 0-10 grading system, where 10 is the worst pain possible) of patients with early versus late treatments |
| Spasticity in Botulinum Toxin (BoNT) treated versus untreated patients | 3-24 months | Comparison of modified ashworth scale (MAS) in BoNT treated versus untreated subjects (MAS is a 0 to 5 score, where 5 is the worst rigidity possible). Herein an aggregated wrist and elbow score (on a 0 - 10 scale with 10 being the worst spasticity) will be used. |
| Upper limb functionality | 3-24 months | Comparison of functional items of upper limb functionality (arm activity measure scale, i.e. ARM-A a 0-84 scale - a higher score means a worse upper limb function) of early versus late treatments |
| Quality of life in Botulinum Toxin treated versus untreated patients | 3-24 months | Comparison of Quality of life (EuroQoL-5D or EQ-5D scale is a 5 to 25 scale where 25 is the lower quality of life possible) in BoNT treated versus untreated patients |
| Pain in Botulinum Toxin treated versus untreated patients | 3-24 months | Comparison of pain (visual analogue scale, VAS, 0-10 scale where 10 is the worst pain possible) in BoNT treated versus untreated patients |
| Functionality in Botulinum Toxin treated versus untreated patients | 3-24 months | Comparison of functionality (arm activity measure, i.e. ARM-A total score, a 0 to 84 scoring system - higher score means a worse upper limb function) in BoNT treated versus untreated subjects |
| Quality of Life measurement | 3-24 months | Comparison of Quality of Life (EuroQoL-5D or EQ-5D scale , 5 to 25 scale where 25 is the worst quality of life possible) of patients with early versus late treatments |
Countries
Italy
Contacts
Primary ContactMassimo Marano, MD
Outcome results
None listed