Comprehensive Observational & Longitudinal Study on the Outbreak of Stroke Related Spasticity Focusing on the Early Onset Management With BoNT: The COLOSSEO-BoNT Study
Overview
- Phase
- Not Applicable
- Intervention
- Botulinum toxin type A
- Conditions
- Spasticity as Sequela of Stroke
- Sponsor
- Campus Bio-Medico University
- Enrollment
- 960
- Locations
- 4
- Primary Endpoint
- Upper limb post stroke-spasticity development
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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
Investigators
Massimo Marano
Principal Investigator
Campus Bio-Medico University
Eligibility Criteria
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.
Arms & Interventions
Late BoNT treatment
Patients with PSS treated with BoNT within the third Quartile of injection timing distribution
Intervention: Botulinum toxin type A
Early BoNT treatment
Patients with PSS treated with BoNT within the first Quartile of injection timing distribution
Intervention: Botulinum toxin type A
Outcomes
Primary Outcomes
Upper limb post stroke-spasticity development
Time Frame: 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 Outcomes
- Post-Stroke Spasticity in early vs late treatment(3-24 months)