Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors (PROGRESS)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Stroke; Functional Recovery; Prognostic Factors

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.

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Raffaella Chieffo, MD, PhD; Phone Number: 0226432755; Email: chieffo.raffaella@hsr.it
• Study Contact Backup: Name: Elisabetta Sarasso, MSc, PT; Phone Number: 0226433051; Email: sarasso.elisabetta@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Elisabetta Sarasso, MSc, PT; Phone Number: 0226433051; Email: sarasso.elisabetta@hsr.it
    • Contact: Raffaella Chieffo, MD, PhD; Phone Number: 0223432755; Email: chieffo.raffaella@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects suffering from acute stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute stroke patients; Subjects admitted in the neurology unit at San Raffaele Hospital for acute stroke meeting the inclusion criteria will be enrolled in the observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PROGRESS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No