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NCT Number: NCT06465758

Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Functional Recovery Nervous System Diseases Prognostic Factors Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    To evaluate walking ability (independence). Score ranges from 0 (non-functional ambulation) to 5 (independent ambulation).

  2. 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

    To evaluate global disability. The score ranges from 0 (indicating no symptoms) to 6 (indicating deceased).

  3. 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

    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.

  4. 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

    To evaluate cognitive functions. Scores range from 0 to 30. Higher scores indicate better cognitive functions.

  5. 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

    To evaluate levels of anxiety and depression. Scores range from 0 (normal) to 21 (abnormal).

  6. 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

    To evaluate activities of daily living. The score ranges from 0 (complete dependency) to 100 (complete independency).

  7. 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

    To assess motor impairment. The score ranges from 0 to 100, with higher scores indicating lower motor impairment.

  8. 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

    To evaluate spasticity. The scoring system ranges from 0 to 4, with higher scores indicating increased spasticity.

  9. 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

    To evaluate muscle strength. The score ranges from 0 (indicating no muscle contraction) to 5 (normal muscle power). Higher scores indicate greater strength.

  10. ABILHAND

    Time frame: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    To assess mobility and dynamic balance. Scoring: time (seconds) taken to perform a mobility task. More time corresponds to worse performance.

  14. 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

    To assess gait speed. Scoring: time (seconds) to walk 10 meters. More time corresponds to worse performance.

  15. 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

    To assess walking endurance. Scoring: distance (meters) walked in 6 minutes. More meters indicate better performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabetta Sarasso, MSc, PT

CONTACT

[email protected]

0226433051

Raffaella Chieffo, MD, PhD

CONTACT

[email protected]

0226432755

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: PROGRESS

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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