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.
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.
Study Type
OBSERVATIONAL
Enrollment
360
IRCCS San Raffaele
Milan, Italy
RECRUITINGAction Research Arm Test (ARAT)
To evaluate upper limb functional recovery. The score ranges from 0 (indicating low functional recovery) to 57 (high functional recovery).
Time frame: Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Functional Ambulation Classification (FAC)
To evaluate walking ability (independence). Score ranges from 0 (non-functional ambulation) to 5 (independent ambulation).
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)
To evaluate global disability. The score ranges from 0 (indicating no symptoms) to 6 (indicating deceased).
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)
To evaluate motor function in the upper and lower limbs. The motor score ranges from 0 (indicating hemiplegia) to 100 points (representing normal motor performance) with 66 points allocated for the upper extremity and 34 points for the lower extremity.
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)
To evaluate cognitive functions. Scores range from 0 to 30. Higher scores indicate better cognitive functions.
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)
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To evaluate levels of anxiety and depression. Scores range from 0 (normal) to 21 (abnormal).
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)
To evaluate activities of daily living. The score ranges from 0 (complete dependency) to 100 (complete independency).
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)
To assess motor impairment. The score ranges from 0 to 100, with higher scores indicating lower motor impairment.
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)
To evaluate spasticity. The scoring system ranges from 0 to 4, with higher scores indicating increased spasticity.
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)
To evaluate muscle strength. The score ranges from 0 (indicating no muscle contraction) to 5 (normal muscle power). Higher scores indicate greater strength.
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
ABILHAND
To assess manual ability. Scoring: Patients are prompted to assess their perceived difficulty in task performance. Scores range from 0 (impossible to perform) to 46 (easy to perform). Higher scores indicate better manual ability.
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)
To assess trunk and postural control. Scoring: points are earned based on performance in mobility tasks. Score ranges from 0 to 100. Higher scores reflect better trunk and postural control.
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)
To assess transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Scoring: points are awarded for performing balance tasks. Higher scores indicate better performance.
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Timed Up and Go Test (TUG)
To assess mobility and dynamic balance. Scoring: time (seconds) taken to perform a mobility task. More time corresponds to worse performance.
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
10 Meters Walking Test (10MWT)
To assess gait speed. Scoring: time (seconds) to walk 10 meters. More time corresponds to worse performance.
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
6 Minutes Walking Test (6MWT)
To assess walking endurance. Scoring: distance (meters) walked in 6 minutes. More meters indicate better performance.
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up