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

Not yet recruiting

• Conditions: Spasticity as Sequela of Stroke
• Interventions: Drug: Botulinum toxin type A

• Registration Number: NCT05379413
• Lead Sponsor: Campus Bio-Medico University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-13
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-18
• Last Update Posted: 2022-05-23
• Study Start: 2022-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

• Ischemic stroke with onset not far than 10 days before the enrollment
• BoNT naive
• Ability to sign the informed consent

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early BoNT treatment	Botulinum toxin type A	Patients with PSS treated with BoNT within the first Quartile of injection timing distribution
Late BoNT treatment	Botulinum toxin type A	Patients with PSS treated with BoNT within the third Quartile of injection timing distribution

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

ASL RM 1 San Filippo Neri Hospital; 🇮🇹 Roma, Lazio, Italy

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Roma, Lazio, Italy

Sapienza University of Rome - Stroke Unit; 🇮🇹 Roma, Lazio, Italy

Sapienza University of Rome; 🇮🇹 Roma, Lazio, Italy