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Study of brain and leg muscle characteristics identified using magnetic resonance imaging (MRI) to predict the likelihood of leg function recovery following stroke

Study In NOvel Neuro-muscular Imaging biomarkers for Motor outcome in Stroke (SINONIMS)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14822732
Enrollment
30
Registered
2020-04-22
Start date
2019-07-15
Completion date
Unknown
Last updated
2023-11-20

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

Conditions

Acute ischaemic stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

30 acute ischaemic stroke patients with varying degrees of lower limb weakness will undergo advanced magnetic resonance imaging of the brain and thigh muscles, followed by assessments of baseline lowe
however, it will inform future multicentre studies by exploring feasibility and providing means by which to perform a sample size calculation. In future, this could improve the efficiency of rehabilit

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 or over with first-ever unilateral supra-tentorial ischaemic stroke 2. Unilateral lower limb motor deficit +/- upper limb motor deficit 3. Less than 4 weeks after stroke onset

Exclusion criteria

Exclusion criteria: 1. Absolute contra-indication to MRI (e.g. pacemaker) 2. Posterior circulation or haemorrhagic stroke (haemorrhagic transformation of ischaemic stroke is not considered as an exclusion criterion) 3. Previous history of anterior circulation stroke (clinically or radiologically) or posterior circulation stroke with residual clinical deficit 4. Lack of capacity to provide informed consent 5. Unable to transfer independently or with assistance of one person if scanned in Newcastle University or with assistance of two people if scanned in Royal Victoria Infirmary 6. Unable to answer MRI safety questionnaire 7. Moderate to high level of dependency prior to stroke (modified Rankin score of >2) 8. Any other pre-existing co-morbidity causing a significant lower limb deficit

Design outcomes

Primary

MeasureTime frame
Lower limb functional impairment measured using the Fugl Meyer Lower Limb Assessment at baseline and 3 months post stroke

Secondary

MeasureTime frame
Measured at baseline and 3 months post stroke: 1. Leg muscle strength measured using lower limb dynamometry 2. Severity of functional impairment measured using the Lower Limb component of the National Institute of Health Stroke Scale 3. Walking ability measured using the Functional Ambulation Category scale

Countries

England, United Kingdom

Contacts

Public ContactHannah Lumley
hannah.lumley@newcastle.ac.uk+44 (0)191 208 5847

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026