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NCT Number: NCT05389878

Implementation of a Registry for Patients With Stroke

Pathology registers are scientific research tools for the development of epidemiological and clinical studies and health planning, which allows access to useful elements for planning adequate health services. The Registry collects demographic, clinical and functional data of stroke patients and arises from the need to order and update this information for epidemiological and research purposes, for a better knowledge of this pathology from a rehabilitation point of view and to accelerate the development of new treatments.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy

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About this study

The Italian Society of Physical and Rehabilitation Medicine has published a minimal assessment protocol for stroke patients1 (PMIC2020) to share the evaluation of stroke rehabilitation needs and outcomes at any time of the rehabilitation pathway, as grounds for a National Stroke Rehabilitation Registry (SRR).

The STRATEGY multicentric study aims to verify the feasibility of implementing a PMIC2020-based SRR in a routine clinical setting, and develop data-driven prognosis prediction models.

Demographic, functional and clinical variables will be collected at the admission and the discharge of the patient; in addition, two telephone follow-ups (three months and six months from the event) will be carried out

The study will involve several rehabilitation centers of the Don Gnocchi Foundation, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (over 18 years of age) with ischemic or haemorrhagic stroke, first event or with relapse, time to onset of stroke less than 6 months, signature of informed consent by the patient or family member.

Exclusion criteria

  • Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life

Treatment and study plan

rehabilitation

Other

All patients addressing intemsive inpatient post stroke rehabilitation undergo a shared evidence based Integrated Care pathway that is routinely adopted in all the participating Centres

Primary outcomes

  1. Change in modified Barthel Index

    Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)

    measure of ability in activity of daily living range 0 worst- 100 best

Secondary outcomes

  1. Change in modified Rankin Score

    Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)

    measure of global disability range 0 best-5 worst

  2. Change in Functional Ambulation Category

    Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)

    measure of functional ambulation range 0 worst- 6 best

  3. Change in Trunk Control Test

    Time frame: Admission, discharge (average 30 days from admission)

    measure of trunk control range 0 worst- 100 best

  4. Change in Short Physical Performance Battery

    Time frame: Admission, discharge (average 30 days from admission)

    measure of lower limbs physical performance range 0 worst-12 best

  5. Change in Motricity Index

    Time frame: Admission, discharge (average 30 days from admission)

    Measure of motricity in upper and lower limb range 0 worst-100 best

  6. Change in Modified Ashworth Scale

    Time frame: Admission, discharge (average 30 days from admission)

    Measure of upper and lower limb spasticity range range 0 best 100

  7. Change of Mini Mental State Examination

    Time frame: Admission, discharge (average 30 days from admission)

    Cogntive level, range from 0 worst - 30 best

Study contacts

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

Francesca Cecchi, MD

CONTACT

[email protected]

+393388627184

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

STroke RehabilitATion rEgistrY for Predicting Functional Outcomes

Acronym: STRATEGY

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 25, 2022
Registry last updated
Mar 11, 2025

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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