Stroke Circulatory System
Conditions
Interventions
Participants will be randomised using a secure web-based system and a minimisation algorithm. The minimisation procedure will minimise group imbalance among the two intervention groups. Groups will b
Sponsors
Royal Cornwall Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New (first/recurrent) clinical diagnosis of stroke, cerebral haemorrhage or infarct confirmed by consultant or CT scan leading to admission to the SRU 2. Aged 18 years and over 3. Graded as mRS 4 or 5 and/or NIHSS=16 (severe or very severe stroke and unable to stand without support/mechanical aid and assistance of two people) 4. Able to give informed consent or assent from a consultee 5. Conscious and responsive to verbal commands
Exclusion criteria
Exclusion criteria: 1. Systolic blood pressure =100mmHg or =220mmHg at rest lying or sitting 2. Oxygen saturation =87% with or without supplementary oxygen (e.g. severe acute/chronic cardiorespiratory disease) 3. Resting heart rate of =40 or =110 beats per minute (e.g. cardiovascular instability) 4. Temperature =38.5 degrees centigrade or =35 degrees centigrade 5. Orthopaedic impairments which prevent full weight bearing in standing 6. Malnutrition Universal Screening Tool score of =2, or not meeting nutritional demands for therapeutic interventions 7. Documented clinical decision for receiving end of life care 8. Unstable coronary or other medical condition that is judged by the PI/CI or clinical team to impose a medical risk to the patient by involvement in the study 9. Severe communication and/or cognitive deficit which affects their ability to follow instructions (e.g. assessed functionally by specialist clinicians as being a risk to themselves or others due to their inability to follow non-verbal prompts or are behaving erratically) 10. Immobile and not weight bearing pre-stroke 11. Additional neurological deficits unrelated to the current or past stroke (e.g. peripheral neuropathy or Multiple Sclerosis), because these impairments are not related to the condition of interest 12. Weight of 115kg or more, this is the weight limit on the standing frames 13. Being discharged out of county, e.g. admitted during holiday/visit to Cornwall or Devon because they would be unable to participate in follow-up assessments 14. Already registered in an intervention trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Function/ability to undertake activities of daily living is measured using the Barthel Index of Activities of Daily Living and Edmans Activities of Daily Living Index for Stroke Patients at baseline, 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure is measured using sphygmomanometer at baseline, 3, 6 and 12 months 2. Knee muscle strength is measured using hand held dynamometer at baseline, 3, 6 and 12 months 3. Length of muscles at hip, knee and ankle is measured using Goniometry at baseline, 3, 6 and 12 months 4. Muscle tone is measured using the Modified Ashworth Scale at baseline, 3, 6 and 12 months 5. Balance/trunk control is measured using the Trunk Control Test at baseline, 3, 6 and 12 months 6. Mood is measured using the PHQ-9/SAD-Q10 at baseline, 3, 6 and 12 months 7. Quality of life is measured using the Stroke & Aphasia Quality of Life Scale-39 at baseline, 3, 6 and 12 months 8. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6 and 12 months 9. Fatigue is measured using the Fatigue Visual Analogue Scale at baseline, 3, 6 and 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed