Skip to content

Sleep and Motor Learning in Stroke

Investigating Consolidation of Motor Learning in the Context of Recovery After Stroke

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05746260
Acronym
SMiLES
Enrollment
150
Registered
2023-02-27
Start date
2023-03-01
Completion date
2027-03-31
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Rehabilitation, Motor Consolidation

Brief summary

This study will explore whether sleep disruption in the sub-acute phase of stroke explains variation in clinical motor outcomes, and whether this relationship is mediated by variation in behavioural measures of overnight consolidation.

Detailed description

Rehabilitation of movement after stroke depends on motor learning. Motor learning involves not only improvement during practice but also improvement between sessions, known as consolidation of learning. Consolidation of learning depends on good sleep quality. However, there is growing evidence that sleep is disrupted after stroke, and it was recently shown that patients with poorer sleep show slower recovery of function and worse motor outcomes. This might occur because sleep disruption impairs consolidation directly or might reflect other factors that influence both sleep and clinical outcomes. This study aims to test whether the relationship between sleep disruption and clinical outcomes after stroke depends on consolidation of motor learning. 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).

Interventions

None listed

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participant is willing and able to give informed consent for participation in the study OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice * Aged 18 years or above * Within 1 month of onset of stroke affecting the upper limb as confirmed by clinical diagnosis

Exclusion criteria

* Other neurological condition affecting movement (such as Parkinson's disease, Multiple Sclerosis)

Design outcomes

Primary

MeasureTime frameDescription
Sleep fragmentation at 1-month1 month post-strokeAssessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).
Behavioural motor consolidation1 month post-strokeAssessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest
Upper limb ability6 month post-strokeAssessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)
Symptoms of insomnia at 1-month1 month post-strokeAssessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)

Secondary

MeasureTime frameDescription
Mobility6 months post-strokeAssessed using the Rivermead Mobility Index, range 0-15 (higher score indicates better functional mobility)
Whole body motor impairment6 months post-strokeAssessed using the Fugl-Meyer Assessment, range 0-100 (higher score indicates better functional mobility)
Hand dexterity6 months post-strokeAssessed using the Nine Hole Peg Test, scored as the number of pegs placed in 30 seconds (greater number of pegs indicates better hand dexterity)
Estimated Total Sleep Time1 and 6 months post-strokeAssessed using actigraphy (wearable activity monitor) over 7-nights
Wake After Sleep Onset1 and 6 months post-strokeAssessed using actigraphy (wearable activity monitor) over 7-nights (higher amount of wake after sleep onset indicates worse sleep)
Symptoms of insomnia at 6-months6 months post-strokeAssessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)

Other

MeasureTime frameDescription
Risk of Obstructive Sleep Apnoea1 month post-strokeAssessed using the STOP BANG questionnaire, range 0-8 (higher values indicate higher risk)
Physical activity1 and 6 months post-strokeAssessed using actigraphy (wearable activity monitor) over 5 days
Mood (Depression)1 and 6 months post-strokeAssessed using the Patient Health Questionnaire (8-item), range 0-24 (higher values indicate more depressive symptoms)
Stroke severity1 and 6 months post-strokeAssessed using the modified Rankin Scale, range 0-6 (higher values indicate more severe stroke)
Electroencephalography (EEG) Sleep Measures1 month post-strokeAt home electroencephalography (EEG) headband for assessing sleep measures (e.g. sleep spindle amplitude, spindle density, sleep staging, cross-frequency coupling)
Presence of Sleep Disorders1 month post-strokeAssessed using the Sleep Disorders Screening questionnaire. Positive responses within sub-groups of questions indicate potential presence of specific sleep disorders.

Countries

United Kingdom

Contacts

Primary ContactMelanie K Fleming, Dr
melanie.fleming@ndcn.ox.ac.uk01865 611 461
Backup ContactBarbara Robinson
sleep-win@ndcn.ox.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026