FIND Stroke Recovery: A Longitudinal Frequent Evaluation Long-term Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Göteborg University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Medical data Clinical data
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Neuroimaging
Time Frame: Baseline, and change from baseline at 3, and 12 months; 2 years
Changes in MRI scans between baseline and follow-ups.
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.
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.
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.
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.