None listed
Conditions
Brief summary
RETHINK is a cohort study to REconsider THe Factors that INfluence stroKe recovery. The hypothesis is that there are domain specific biological biomarkers and psychosocial determinants that predict clinically relevant recovery after stroke. The primary aim of this study is to investigate and characterise biomarker and psychosocial determinants for upper limb motor deficits that associate with favourable and unfavourable recovery at multiple time-points following ischaemic stroke. These common deficits affect upwards 70% of those with a stroke making it a particularly pertinent focus of study. In addition to upper motor deficits, RETHINK will investigate stroke recovery across specific domains (lower limb, cognitive-aphasia, neglect, sensory) using a global approach. Participants will be asked to provide blood and microbiome samples at study enrolment and at primary and secondary time-points. Participants will also be asked to complete one Patient Reported Outcome Measure (PROMS) online survey about quality of life and for a small subgroup, will be invited to participate in one face to face interview about their experiences in the study and with the outcome metrics.
Interventions
This observational study will observe psychological determinants and blood/microbiome biomarkers that influence ischaemic stroke neurological domain specific outcomes, (for Motor Function Upper /Lower limb; Cognitive- Aphasia; Cognitive- Neglect; Cognitive-any deficit; Sensory;Depression ). Patients will be asked to provide a blood sample and faecal sample on enrolment. Depending on their domain of deficit, they will be asked to provide additional blood and faecal samples at 3, 6 ,12 and 24 mont
This observational study will observe psychological determinants and blood/microbiome biomarkers that influence ischaemic stroke neurological domain specific outcomes, (for Motor Function Upper /Lower limb; Cognitive- Aphasia; Cognitive- Neglect; Cognitive-any deficit; Sensory;Depression ). Patients will be asked to provide a blood sample and faecal sample on enrolment. Depending on their domain of deficit, they will be asked to provide additional blood and faecal samples at 3, 6 ,12 and 24 months follow up time-points. All participants will be asked for permission for study nurses to access their clinical in hospital data, and all will be asked to complete an online survey about quality of life at 12 and 24 months. Follow up clinical assessments will be conducted int he participants homes or a community clinic setting. For the qualitative arm of the study- All participants from each domain group will be invited on enrolment to take part in 2 face to face or audio recorded telephone interviews, at 12 and 24 months post enrolment. Recruitment will continue until 10 stroke survivors from each domain have been recruited with the aim to recruit 70 stroke cases (10 from each domain). Duration of each interview will be approximately 30 minutes.
Sponsors
University of Technology Sydney
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ischaemic stroke cases defined in consultation with specialist neurologist and based on routine care imaging (CT and/or MRI); greater than 18 years old and have persistent symptoms of any deficit for greater than 5-7 days. Stroke is defined by standard definitions and then stratified into groups according to domains of deficit. Each recovery domain will be defined by clinical symptom items as per National Institute of Health Stroke Scale (NIHSS). Parameters include deficit symptoms persisting for greater than 5-7 days.
Exclusion criteria
Severe illnesses i.e. palliative medical management in place, another neurological condition, seizure activity that prevent NIHSS assessment, patients unable to provide consent due to communication deficits or have no access to appropriate substitute decision maker, carer or in the case of non-English speaking case, a translator. For study subjects who agree to participate in the faecal microbiome arm, exclusion will include a history of inflammatory bowel disease or antibiotic use within 30 days of admission.
Outcome results
None listed