Stem cell trial of recovery enhancement after stroke 3
Not Applicable
Completed
- Conditions
- Topic: Stroke Research NetworkSubtopic: RehabilitationDisease: Community studyCirculatory SystemSequelae of stroke
- Registration Number
- ISRCTN16714730
- Lead Sponsor
- niversity of Nottingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Feasibility<br>2. Proportion of participants receiving all 5 GCSF/ placebo injections<br>3. Proportion of participants receiving all 18 therapy sessions
- Secondary Outcome Measures
Name Time Method 1. Acceptability<br>2. Proportion of participants screened who are eligible for enrollment who give consent<br>3. Tolerability<br>4. Adverse events (headache, backache) reported after G-CSF administration<br>5. Secondary Haematological (FBC, WCC, CD34, PLT)<br>6. Post therapy intervention (day 45 and, end of follow-up day 90): <br>6.1. Motor function (RMA)<br>6.2. Change in dependency (modified Rankin Scale shift)<br>6.3. Change in disability (change in BI)<br>6.4. Quality of life (EuroQoL)<br>6.5. Care giver burden