MedTrace Logo

Observational Longitudinal Study on the Outbreak and Management of Stroke Related Spasticity

NCT05379413 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 960

Last updated 2022-05-23

No results posted yet for this study

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

Conditions

  • Spasticity as Sequela of Stroke

Interventions

DRUG

Botulinum toxin type A

Botulinum neurotoxin (BoNT) Type A injection with either OnaBoNT-A, AboBoNT-A, IncoBoNT-A

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-06-01
Completion
2025-06-01
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379413 on ClinicalTrials.gov