Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Participants will be randomized to either NeuroVirt or the control group via a computer-generated system and will be administered by someone who is not directly connected to the research team.
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A stroke (ischaemic or haemorrhagic) at least 3 months previously 2. Have at least a little motion of the upper limb impairment but not have full dexterity i.e. be able to lift their arm from their lap and place it on a table in front of them but not be able to stack 5 five pence coins 3. Can navigate the NeuroVirt device independently on the first trial day OR has a family member/carer on a daily basis that can help with wearing the device at the patient’s home independently 4. Has at least a weak Wifi connection at their home 5. Live within around 1 hour's travelling distance of Norwich Community Hospital if being recruited from Norfolk or Suffolk 6. 18 years of age or older
Exclusion criteria
Exclusion criteria: 1. Other neurological diagnoses 2. Communication, cognitive and language deficits such that they are unable to follow a one-stage command and give informed consent 3. Frozen shoulder or other impairments affecting the movement of their arm such as arthritis 4. Any episode of photosensitive epilepsy within the last 12 months 5. Refuse to consent to GP being contacted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper limb motor performance is measured using Fugl Meyer - Upper Extremity at baseline and at the end of the 6-week intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rates measured by multiplying the number of sites and randomized patients per site by the number of months of recruitment time, and attrition measured by the attrition rate at 6 weeks. 2. Adherence will be measured via NeuroVirt or the diaries completed by participants in the control group 3. Upper limb range of movement measurements from NeuroVirt at baseline and at the end of the 6-week intervention period 4. Grip strength measured with a dynamometer at baseline and at the end of the 6-week intervention period 5. Upper limb function measured with Action Research Arm Test at baseline and at the end of the 6-week intervention period 6. Activity in the hemiparetic arm measured with arm activity measure (Arm A) at baseline and at the end of the 6-week intervention period 7. Health-related quality of life measured using EQ5D-5L at baseline and at the end of the 6-week intervention period 8. Fatigue will be measured using the Fatigue Assessment Scale at baseline and at the end of the 6-week intervention period 9. Pain will be measured using Pain Visual Analogue Scale at baseline and at the end of the 6-week intervention period 10. Useability and acceptability assessed via interviews at 6 weeks 11. Adverse events will be measured using the adverse event reporting form Version 1 at 6 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed