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ClinicalTrials.gov ID

NCT05379413

Lead Sponsor

Campus Bio-Medico UniversityOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

960Estimated

Last Update Posted

May 23, 2022Actual

Start Date

Jun 1, 2022Estimated

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jun 1, 2025Estimated

Official Title

Comprehensive Observational & Longitudinal Study on the Outbreak of Stroke Related Spasticity Focusing on the Early Onset Management With BoNT: The COLOSSEO-BoNT Study

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

• Spasticity as Sequela of Stroke

• Botulinum toxin type A

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Campus Bio-Medico UniversityOTHER

antonio.suppa@uniroma1.it