Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2023-03-01
2027-03-31
Brief Summary
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Detailed Description
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In people with stroke affecting the upper limb, the investigators will (1) test whether sleep measures in the sub-acute phase explains variation in clinical motor outcomes, taking into account recovery potential (as per the PREP2 algorithm(Predict REcovery Potential; www.presto.auckland.ac.nz)), demographic factors (age and sex) and other covariates as required (e.g. stroke severity, presence of sleep disorders, mood, physical activity), and (2) test whether this relationship is mediated by variation in behavioural measures of overnight motor consolidation.
The design is a longitudinal observational study. Participants will be recruited within 1 month of stroke onset from stroke wards. At baseline (≤ 1 month post-stroke), the investigators will use the PREP2 algorithm (www.presto.auckland.ac.nz) to ascertain expected upper limb recovery potential. This involves an assessment of arm movement and, for some participants, Transcranial Magnetic Stimulation to assess corticospinal tract integrity. The investigators will also record participant demographics, stroke severity (National Institute for Health Stroke Scale; NIHSS), and medications.
At approximately 1 month post-stroke the investigators will obtain sleep measures (actigraphy, electroencephalography, and questionnaires), assess mood (questionnaire) and test for motor consolidation (using an upper limb motor learning task). The investigators will also record medications, stroke severity (modified Rankin Scale questionnaire), and assess the possible presence of sleep disorders (sleep screening questionnaires), physical activity (actigraphy). The investigators will collect information about how much, if any, motor rehabilitation and sleep therapy the participants have received (questionnaire).
At 6 months post-stroke the investigators will obtain sleep measures (actigraphy, and questionnaire) and assess motor outcomes (upper limb ability, whole body motor impairment, hand dexterity, and mobility). The investigators will also record medications and assess mood (questionnaire), stroke severity (modified Rankin Scale questionnaire), physical activity (actigraphy), and information about how much, if any, motor rehabilitation and sleep therapy the participants have had (questionnaire).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or above
* Within 1 month of onset of stroke affecting the upper limb as confirmed by clinical diagnosis
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Heidi Johansen-Berg, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Weightman M, Robinson B, Mitchell MP, Garratt E, Teal R, Rudgewick-Brown A, Demeyere N, Fleming MK, Johansen-Berg H. Sleep and motor learning in stroke (SMiLES): a longitudinal study investigating sleep-dependent consolidation of motor sequence learning in the context of recovery after stroke. BMJ Open. 2024 Feb 13;14(2):e077442. doi: 10.1136/bmjopen-2023-077442.
Other Identifiers
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PID 16062
Identifier Type: -
Identifier Source: org_study_id
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