Clinical trial NCT06465758: Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
Official title: Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Stroke
Functional Recovery
Prognostic Factors
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects suffering from acute stroke

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.

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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Secondary outcomes:
measure: Functional Ambulation Classification (FAC)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Modified Rankin Scale (MRS)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Fugl-Meyer Assessment for upper and lower limb (FMA- UL and LL)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Barthel Index (BI)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Motricity Index (MI)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Ashworth Scale (AS)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Medical Research Council Scale (MRC)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: ABILHAND
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Trunk Control Test (TCT)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Mini Balance Evaluation Test (Mini-BESTest)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: Timed Up and Go Test (TUG)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: 10 Meters Walking Test (10MWT)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
measure: 6 Minutes Walking Test (6MWT)
timeFrame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
Study officials:
References: