Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
- Conditions
- Acute StrokeFunctional RecoveryPrognostic Factors
- Registration Number
- NCT06465758
- Lead Sponsor
- IRCCS San Raffaele
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
- 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
- Transient ischaemic attack
- Premorbid Modified Rankin Scale ≥ 4
- Acute orthopaedic complications
- Inability to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Action Research Arm Test (ARAT) Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate upper limb functional recovery. The score ranges from 0 (indicating low functional recovery) to 57 (high functional recovery).
- Secondary Outcome Measures
Name Time Method Timed Up and Go Test (TUG) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To assess mobility and dynamic balance. Scoring: time (seconds) taken to perform a mobility task. More time corresponds to worse performance.
Medical Research Council Scale (MRC) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate muscle strength. The score ranges from 0 (indicating no muscle contraction) to 5 (normal muscle power). Higher scores indicate greater strength.
Mini Balance Evaluation Test (Mini-BESTest) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up 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.
Fugl-Meyer Assessment for upper and lower limb (FMA- UL and LL) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up 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.
Barthel Index (BI) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate activities of daily living. The score ranges from 0 (complete dependency) to 100 (complete independency).
Functional Ambulation Classification (FAC) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate walking ability (independence). Score ranges from 0 (non-functional ambulation) to 5 (independent ambulation).
Ashworth Scale (AS) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate spasticity. The scoring system ranges from 0 to 4, with higher scores indicating increased spasticity.
Trunk Control Test (TCT) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up 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.
10 Meters Walking Test (10MWT) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To assess gait speed. Scoring: time (seconds) to walk 10 meters. More time corresponds to worse performance.
Modified Rankin Scale (MRS) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate global disability. The score ranges from 0 (indicating no symptoms) to 6 (indicating deceased).
Montreal Cognitive Assessment (MOCA) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate cognitive functions. Scores range from 0 to 30. Higher scores indicate better cognitive functions.
Motricity Index (MI) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To assess motor impairment. The score ranges from 0 to 100, with higher scores indicating lower motor impairment.
Hospital Anxiety and Depression Scale (HADS) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To evaluate levels of anxiety and depression. Scores range from 0 (normal) to 21 (abnormal).
ABILHAND Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up 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.
6 Minutes Walking Test (6MWT) Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up To assess walking endurance. Scoring: distance (meters) walked in 6 minutes. More meters indicate better performance.
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Milano, Italy