Acute StrokePROGRESSNCT06465758
Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
An observational study of Acute Stroke and Functional Recovery, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Functional Recovery, Prognostic Factors
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2024to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects suffering from acute stroke
Who may be able to join
- 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
Who cannot join
- Transient ischaemic attack
- Premorbid Modified Rankin Scale ≥ 4
- Acute orthopaedic complications
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, 20132
Raffaella Chieffo, MD, PhD, 0223432755, chieffo.raffaella@hsr.it
Elisabetta Sarasso, MSc, PT, 0226433051, sarasso.elisabetta@hsr.it
About this study
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.
Read the 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.
- Conditions
- Acute Stroke, Functional Recovery, Prognostic Factors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
To evaluate walking ability (independence). Score ranges from 0 (non-functional ambulation) to 5 (independent ambulation).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start21 May 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Massimo Filippi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465758
- Sponsor's protocol ID
- PROGRESS
- Acronym
- PROGRESS
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
- ClinicalTrials.gov ID
- NCT06465758
- Acronym / sponsor ID
- PROGRESS / PROGRESS
- Conditions
- Acute Stroke, Functional Recovery, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from acute stroke
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Transient ischaemic attack
- Premorbid Modified Rankin Scale ≥ 4
- Acute orthopaedic complications
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Action Research Arm Test (ARAT)
Time frame: 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).
15 secondary outcomes
Functional Ambulation Classification (FAC)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Barthel Index (BI)
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Motricity Index (MI)
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Ashworth Scale (AS)
Time frame: 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)
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
ABILHAND
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke and Functional Recovery, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raffaella Chieffo, MD, PhD (0226432755, chieffo.raffaella@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.