NCT07504692

Brief Summary

The study aims to investigate the impact that the set of factors to which a post-stroke person is exposed during daily life can have on their health. The study will examine the totality of conditions, known as the "exposome," which include biological, environmental, social, and lifestyle factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

March 26, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 5, 2026

Last Update Submit

March 25, 2026

Conditions

Stroke

Keywords

CaregiverHuman FunctioningEnvironmentBiomarkersExposome

Outcome Measures

Primary Outcomes (6)

  • Motor measures

    10 metres walking test

    Baseline

  • Motor measure

    6 minutes walking test

    Baseline

  • Motor Measure

    Timed Up and Go test

    Baseline

  • Motor measure

    Berg balance scale

    Baseline

  • motor outcome measure

    Functional Ambulation Category

    Baseline

  • Cognitive measure

    MoCa Test

    Baseline

Secondary Outcomes (9)

  • Biomarkers from blood samples

    Baseline

  • Biomarkers from blood samples

    Baseline

  • Biomarkers from blood samples

    Baseline

  • Biomakers from blood samples

    baseline

  • Biomarkers from blood samples

    Baseline

  • +4 more secondary outcomes

Study Arms (1)

Post stroke patients in chronic condition

The study will include patients with post-stroke outcomes and their caregivers. Patients with ischemic or hemorrhagic stroke outcomes will be included, divided into age groups: a) 30 pediatric stroke patients (age \< 18 years at the time of the acute event) ; b) 120 stroke patients (60 patients aged ≤ 65 years at the time of the acute event, 60 patients aged \> 65 years at the time of the acute event). Of these, 40 patients will be 10 years post acute event, 40 patients will be 5 years post acute event, and 40 will be recruited from patients hospitalized for a recent stroke event. The selected population will be representative of the general population of patients with post-stroke disabilities, reflecting their biodiversity in terms of sex, age, ethnicity, educational level, socioeconomic conditions, and level of motor and cognitive impairment.

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

post-stroke patients

You may qualify if:

  • Subjects with Cerebral Stroke, both ischemic and hemorrhagic, in either pediatric or adult age;
  • Age \> 5 years
  • Absence of ongoing clinical acute conditions
  • Able to provide written informed consent to participate in the study if of legal age, or consent from a legal representative if a minor
  • Absence of major psychiatric disorders associated with the disability condition

You may not qualify if:

  • Inability to provide informed consent
  • Presence of other neurological conditions (e.g. Multiple Sclerosis, Parkinson's Disease…)
  • Presence of ongoing clinical acute conditions
  • Presence of major psychiatric disorders associated with the disability condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS Scientific Institute E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi

Milan, Milano, 20148, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Franco Molteni, MD

    Villa Beretta Rehabilitation Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 5, 2026

First Posted

April 1, 2026

Study Start

March 26, 2025

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)