Topic: Stroke Research Network
Conditions
Interventions
We will perform a trial testing both GCSF, and a course of therapy given to 60 patients who have disability at least 3 months after their stroke. The patients will be living in the community, and will
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (18 years and over) 2. Male and female participants 3. Motor impairment (arm or leg) with residual disability (modified Rankin Score >1) due to stroke >90 days post onset.
Exclusion criteria
Exclusion criteria: 1. Lack of residual motor deficit 2. Significant cognitive impairment that will impede ability to complete assessments 3. Diagnosis likely to interfere with outcome or rehabilitation (e.g. terminal illness) 4. Still receiving post stroke rehabilitation 5. Pregnancy 6. Other exclusions of GCSF (as per British National Formulary)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility 2. Proportion of participants receiving all 5 GCSF/ placebo injections 3. Proportion of participants receiving all 18 therapy sessions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability 2. Proportion of participants screened who are eligible for enrollment who give consent 3. Tolerability 4. Adverse events (headache, backache) reported after G-CSF administration 5. Secondary Haematological (FBC, WCC, CD34, PLT) 6. Post therapy intervention (day 45 and, end of follow-up day 90): 6.1. Motor function (RMA) 6.2. Change in dependency (modified Rankin Scale shift) 6.3. Change in disability (change in BI) 6.4. Quality of life (EuroQoL) 6.5. Care giver burden | — |
Countries
United Kingdom
Outcome results
None listed