Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors

NCT ID: NCT06465758

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2029-05-31

Brief Summary

This research delves into the acute prognostic factors influencing functional recovery in individuals who have experienced a stroke. The objective is to describe patterns of functional recovery after a stroke and identify new, clinically significant outcomes or metrics that can serve as predictive indicators for post-stroke functional recovery.

Detailed Description

In this prospective observational study with additional procedures, the aim is to describe different patterns of recovery according to clinical characteristics identified during the early phases post stroke. All the additional procedure are functional and clinical tests or questionnaires validated and used for standard stroke clinical practice that pose no risk to the enrolled subject. This study, based at San Raffaele Hospital's stroke unit, will enrol subjects who suffer from stroke assessed in the acute phase (T0), at three-months (T1), six-month (T2) and 1-year post-stroke (T3). No intervention that can interfere with usual clinical practice will be administered between evaluations. Assessments include neurological, neuropsychological and physical therapy questionnaires along with functional tests validated and used in stroke clinical practice.

Conditions

Acute Stroke; Functional Recovery; Prognostic Factors

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute stroke patients

Subjects admitted in the neurology unit at San Raffaele Hospital for acute stroke meeting the inclusion criteria will be enrolled in the observational study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18
• Haemorrhagic or ischaemic stroke confirmed by a clinical diagnosis and by brain imaging
• NIHSS item 5-6 ≥1
• 3 to 10 days post-stroke

Exclusion Criteria

• Transient ischaemic attack
• Premorbid Modified Rankin Scale ≥ 4
• Acute orthopaedic complications
• Inability to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Prof. Massimo Filippi

Professor in Neurology and Director of Stroke Unit, Neurology and neurorehabilitation Units

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raffaella Chieffo, MD, PhD

Role: CONTACT

chieffo.raffaella@hsr.it

0226432755

Elisabetta Sarasso, MSc, PT

Role: CONTACT

sarasso.elisabetta@hsr.it

0226433051

Facility Contacts

Raffaella Chieffo, MD, PhD

Role: primary

chieffo.raffaella@hsr.it

0223432755

Elisabetta Sarasso, MSc, PT

Role: backup

sarasso.elisabetta@hsr.it

0226433051

Other Identifiers

PROGRESS

Identifier Type: -

Identifier Source: org_study_id