Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Transient ischaemic attack
Premorbid Modified Rankin Scale ≥ 4
Acute orthopaedic complications
Inability to give informed consent
Trial population
Subjects suffering from acute stroke
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
360 Participants
are grouped into 1 trial groupGroup A: Acute stroke patients
Trial outcomes
Primary outcomes
1
Action 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-upSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov