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

Not Applicable

Completed

• Conditions: Acute ischaemic stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN14822732
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37941576/ (added 10/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-22
• Study Completion: 2023-07-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ower limb functional impairment measured using the Fugl Meyer Lower Limb Assessment at baseline and 3 months post stroke

Secondary Outcome Measures

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