StrokeSMiLESNCT05746260
Sleep and Motor Learning in Stroke
An observational study of Stroke, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with stroke affecting the upper limb
Who may be able to join
- 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
Who cannot join
- Other neurological condition affecting movement (such as Parkinson's disease, Multiple Sclerosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbara Robinson contact
United Kingdom1 site, 1 recruiting
- Recruiting
Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, OX3 9DU
Barbara Robinson, sleep-win@ndcn.ox.ac.uk
Melanie K Fleming, Dr, melanie.fleming@ndcn.ox.ac.uk
About this study
Official title: Investigating Consolidation of Motor Learning in the Context of Recovery After Stroke
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.
Read the 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).
- Conditions
- Stroke
- Keywords
- Rehabilitation, Motor Consolidation
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep fragmentation at 1-month
Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).
Measured: 1 month post-stroke
Symptoms of insomnia at 1-month
Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)
Measured: 1 month post-stroke
Upper limb ability
Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)
Measured: 6 month post-stroke
Behavioural motor consolidation
Assessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest
Measured: 1 month post-stroke
Secondary outcomes (6)
Whole body motor impairment
Assessed using the Fugl-Meyer Assessment, range 0-100 (higher score indicates better functional mobility)
Measured: 6 months post-stroke
Hand dexterity
Assessed using the Nine Hole Peg Test, scored as the number of pegs placed in 30 seconds (greater number of pegs indicates better hand dexterity)
Measured: 6 months post-stroke
Mobility
Assessed using the Rivermead Mobility Index, range 0-15 (higher score indicates better functional mobility)
Measured: 6 months post-stroke
Estimated Total Sleep Time
Assessed using actigraphy (wearable activity monitor) over 7-nights
Measured: 1 and 6 months post-stroke
Wake After Sleep Onset
Assessed using actigraphy (wearable activity monitor) over 7-nights (higher amount of wake after sleep onset indicates worse sleep)
Measured: 1 and 6 months post-stroke
Symptoms of insomnia at 6-months
Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)
Measured: 6 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi Johansen-Berg, Professor, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746260
- Sponsor's protocol ID
- PID 16062
- Acronym
- SMiLES
- Status last verified
- Nov 2024
- First submitted
- 17 Feb 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data are available upon reasonable request
Publications
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.
PubMed 38355178
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Consolidation of Motor Learning in the Context of Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05746260
- Acronym / sponsor ID
- SMiLES / PID 16062
- Conditions
- Stroke
- Keywords
- Rehabilitation, Motor Consolidation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with stroke affecting the upper limb
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Other neurological condition affecting movement (such as Parkinson's disease, Multiple Sclerosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep fragmentation at 1-month
Time frame: 1 month post-stroke
Assessed using actigraphy (wearable activity monitor) over 7-nights (more fragmentation indicates worse sleep).
Symptoms of insomnia at 1-month
Time frame: 1 month post-stroke
Assessed using the Sleep Condition Indicator, a questionnaire assessing self-reported insomnia symptoms (range 0-32, higher scores indicate fewer symptoms of insomnia)
Upper limb ability
Time frame: 6 month post-stroke
Assessed using the Action Research Arm Test (range 0-57, higher score indicates better upper limb ability)
Behavioural motor consolidation
Time frame: 1 month post-stroke
Assessed as change in motor performance on a sequential button pressing task (movement time, in seconds) from training to retest
6 secondary outcomes
Whole body motor impairment
Time frame: 6 months post-stroke
Hand dexterity
Time frame: 6 months post-stroke
Mobility
Time frame: 6 months post-stroke
Estimated Total Sleep Time
Time frame: 1 and 6 months post-stroke
Wake After Sleep Onset
Time frame: 1 and 6 months post-stroke
Symptoms of insomnia at 6-months
Time frame: 6 months post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 38355178Weightman 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.
- Individual participant dataSharing planned: Yes. De-identified data are available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Robinson contact
Heidi Johansen-Berg, Professor principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie K Fleming, Dr (01865 611 461, melanie.fleming@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep fragmentation at 1-month (time frame: 1 month post-stroke). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.