FIND Stroke Recovery - A Longitudinal Study (FIND)

March 27, 2025 updated by: Göteborg University

FIND Stroke Recovery: A Longitudinal Frequent Evaluation Long-term Follow-up Study

Stroke survivors frequently suffer disabilities including motor and cognitive problems, impairments in speech and vision, depression, and several other disabilities that worsen their quality of life. Some will recover fully after stroke and others will have permanent impairments. Few studies show trajectories of recovery in different domains after stroke, hence recovery time-lines are not fully known. Also, the whole range of mechanisms leading to recovery are not precisely known (1). To monitor those mechanisms one can utilize biomarkers.

In parallel to the studies of recovery, studies on time series of biomarkers after stroke are limited (2). Hence, a crucial first step to increase knowledge on biomarkers of stroke recovery is to gain a better understanding of the time course of both stroke recovery and biomarker patterns. Biomarkers can later be used for outcome predictions after stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND

Stroke survivors frequently suffer disabilities including motor and cognitive problems, impairments in speech and vision, depression, and several other disabilities that worsen their quality of life. Some will recover fully after stroke and others will have permanent impairements. Few studies show trajectories of recovery in different domains after stroke, hence recovery time-lines are not fully known. Also, the whole range of mechanisms leading to recovery are not precisely known (1). To monitor those mechanisms one can utilize biomarkers.

In parallel to the studies of recovery, studies on time series of biomarkers after stroke are limited (2). Hence, a crucial first step to increase knowledge on biomarkers of stroke recovery is to gain a better understanding of the time course of both stroke recovery and biomarker patterns. Biomarkers can later be used for outcome predictions after stroke.

WORK PLAN

AIM Determine temporal profiles describing the speed, order, and degree of recovery in neurological and cognitive functions in various domains with simultaneous profiling of changes in blood biomarker concentrations, in the acute, subacute phases and long-term of stroke. Determine individual and interindividual variations in recovery in the different domains.

Informed consent Written informed consent will be obtained from all willing participants or their next-of-kin.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE-41345
        • Recruiting
        • Department of Neurology, Department of Neurorehabilitation and Department of Clinical Genetics, Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Investigators enrol patients presenting with first-ever ischemic stroke or intracerebral haemorrhage admitted to the stroke units at the Sahlgrenska University Hospital in Gothenburg, Sweden.

Description

Investigators enrol patients presenting with first-ever ischemic stroke or intracerebral haemorrhage admitted to the stroke units at the Sahlgrenska University Hospital in Gothenburg, Sweden.

The inclusion criteria are:

• first-ever acute ischemic stroke; or intracerebral hemorrhage.

The exclusion criteria are:

  • pre-stroke mRS score of ≥3;
  • severe neurodegenerative disease, cerebral neoplasm or terminal illness; and
  • patients considered unlikely to be able to participate in or to understand and/or comply with study procedures during follow-up visits at the hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational - all
All included stroke patients.
Other: Observational - all
All stroke patients are included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical data Clinical data
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Stroke subtype, medical history, life style questions between baseline and follow-ups
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Stroke severity
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Change of National Institutes of Health Stroke Scale (NIHSS) between baseline and follow-ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Functional independence
Time Frame: Pre-stroke estimation, baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Change of modified Ranking Scale (mRS) functional independence
Pre-stroke estimation, baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Walking ability
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Change in functional Ambulation Category between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Postural control
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Change in postural control, evaluated by Berg Balance Scale (BBS), between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years.
Blood samples
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Analyses of plasma protein levels and circulating RNA profiles in comparison to baseline
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
FMA-arm test
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in performance on Fugl-Meyer Assessment of Motor Recovery after Stroke test between baseline and follow-up.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
SAFE
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in performance on Shoulder Abduction and Finger Extension (SAFE) score between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
MoCA
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the Montreal Cognitive Assessment between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Neuroimaging
Time Frame: Baseline, and change from baseline at 3, and 12 months; 2 years
Changes in MRI scans between baseline and follow-ups.
Baseline, and change from baseline at 3, and 12 months; 2 years
D-FIS
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the Daily Fatigue Impact Scale (D-FIS) between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
HAD
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the Hospital Anxiety and Depression (HAD) scale between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
SIS
Time Frame: Baseline, and change from baseline and 3, 6 and 12 months; 2 and 5 years
Change in domains of Stroke Impact Scale (SIS) between baseline and follow ups.
Baseline, and change from baseline and 3, 6 and 12 months; 2 and 5 years
FAS
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the Verbal Fluency Test between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
CWT
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the Color-Word Interference test between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
TMT
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the Trail Making Test between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
RBANS
Time Frame: Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years
Change in the 10-word test from Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) between baseline and follow ups.
Baseline, and change from baseline at 3, 6 and 12 months; 2 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Christina Jern, MD, PhD, Inst. of Biomedicine, the Sahlgrenska Academy, Univ. of Gothenburg
  • Principal Investigator: Turgut Tatlisumak, MD, PhD, Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg
  • Principal Investigator: Katarina Jood, MD, PhD, Dept. of Neurology, Sahlgrenska Univ. Hosp., Gothenburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized data may be shared by qualified academic research collaborators as long as data transfer is in agreement with EU legislation on the general data protection regulation and decisions by the Ethical Review Board of Sweden and the University of Gothenburg, which should be regulated in a data transfer agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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