FIND Stroke Recovery - A Longitudinal Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Observational - all: All stroke patients are included.

Study 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.

Eligibility

Primary outcome measure(s)

• Medical data Clinical data — 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 — 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 — 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
• Walking ability — 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 — 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.
• Blood samples — 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
• FMA-arm test — 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.
• SAFE — 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.
• MoCA — 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 — Baseline, and change from baseline at 3, and 12 months; 2 years
  Changes in MRI scans between baseline and follow-ups.
• D-FIS — 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.
• HAD — 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 — 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.
• FAS — 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.
• CWT — 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.
• TMT — 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.
• RBANS — 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.

Trial sites (1)

More Göteborg University trials in Sweden

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