Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
PROGRESS
1 other identifier
observational
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedStudy Start
First participant enrolled
May 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
June 20, 2024
June 1, 2024
3.9 years
May 13, 2024
June 13, 2024
Conditions
Outcome Measures
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).
Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Secondary Outcomes (15)
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
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
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
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
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
- +10 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
Subjects suffering from acute stroke
You may qualify if:
- Age ≥ 18
- Haemorrhagic or ischaemic stroke confirmed by a clinical diagnosis and by brain imaging
- NIHSS item 5-6 ≥1
- to 10 days post-stroke
You may not qualify if:
- Transient ischaemic attack
- Premorbid Modified Rankin Scale ≥ 4
- Acute orthopaedic complications
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Raffaele
Milan, 20132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Neurology and Director of Stroke Unit, Neurology and neurorehabilitation Units
Study Record Dates
First Submitted
May 13, 2024
First Posted
June 20, 2024
Study Start
May 21, 2024
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
June 20, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share