Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
NCT Number: NCT06465758
Acronym: PROGRESS
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Stroke|Functional Recovery|Prognostic Factors
Sponsor: IRCCS San Raffaele
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-21
Completion Date: 2029-05
Locations: IRCCS San Raffaele, Milano, 20132, Italy

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.

Primary Outcome Measures: 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)., Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Secondary Outcome Measures: Functional Ambulation Classification (FAC), To evaluate walking ability (independence). Score ranges from 0 (non-functional ambulation) to 5 (independent ambulation)., 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)., 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., 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., 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), To evaluate levels of anxiety and depression. Scores range from 0 (normal) to 21 (abnormal)., 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)., 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., 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., 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., 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., 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., 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., 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., 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., 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., Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up