Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors

Acute Stroke Clinical Trial

— PROGRESS  

Official title:

Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06465758
• Other study ID #: PROGRESS
• Status: Recruiting
• Start date: May 21, 2024
• Est. completion date: May 2029

Study information

• Verified date: June 2024
• Source: IRCCS San Raffaele
• Contact: Raffaella Chieffo, MD, PhD
• Phone: 0226432755
• Email: chieffo.raffaella[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 post-stroke functional recovery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: May 2029
• Est. primary completion date: May 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Functional Recovery
• Prognostic Factors
• Stroke

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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