Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Stroke, Functional Recovery, Prognostic Factors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Action Research Arm Test (ARAT) [Time frame: Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
Secondary outcome measures (12)
- Functional Ambulation Classification (FAC) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Modified Rankin Scale (MRS) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Fugl-Meyer Assessment for upper and lower limb (FMA- UL and LL) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Montreal Cognitive Assessment (MOCA) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Barthel Index (BI) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Motricity Index (MI) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Ashworth Scale (AS) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Medical Research Council Scale (MRC) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- ABILHAND [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Trunk Control Test (TCT) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Mini Balance Evaluation Test (Mini-BESTest) [Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- IRCCS San Raffaele — Milan
Identifiers
NCT: NCT06465758 · PROGRESS