Assessing recovery in patients at 12 months or more after stroke
Research type
Research Study
Full title
A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke
IRAS ID
226727
Contact name
Paul Stroemer
Contact email
Sponsor organisation
ReNeuron Ltd
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Following a stroke, most people experience at least some degree of recovery in the first 6 months, most rapidly in the first few weeks. However, up to 30% have persistent disability of some degree. The underlying processes involved in recovery are not well understood, and also vary substantially among patients. Better understanding of the factors that determine individual potential for recovery may guide rehabilitation treatments, and would also enable more efficient clinical trials of rehabilitation treatments by ensuring that those most likely to benefit from a potential treatment can be targeted.
This observational study assesses the course of recovery in patients at 12 months or more following stroke using four established stroke rating scales. The study does not involve any medical treatment and is purely observational in nature. The patients will be asked to complete 1 study visit only at which the 4 assessments will be carried out. The participants that will be approached in this study have previously consented and taken part in a preceding study that collected the same assessment data but for a period of up to 6 months post stroke.
Participants will undergo 4 assessments at the visit. These are
1) the Action Research Arm Test (ARAT), a measure of arm and hand function; 2) the National Institutes of Health Stroke Scale (NIHSS), a short physical examination to measure neurological function; 3) the Modified Rankin Scale (mRS), a measure of the degree of dependence in daily activities; and 4) the Barthel Index (BI), a scale that measures the degree of independence in daily activities such as dressing, walking and eating.In addition, the study will record details of relevant medications and relevant clinical interventions and medical history since involvement in the previous study. Anonymous copies of brain imaging performed at the time of stroke will also be requested.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0187
Date of REC Opinion
12 May 2017
REC opinion
Favourable Opinion