Stroke Circulatory System
Conditions
Interventions
Potential research participants will be screened when they attend the stroke wards at the two NHS locations participating in the study. If they are deemed initially eligible, they will be approached a
Sponsors
University of Lancashire
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. At least 18 years old 2. Diagnosed with an ischaemic or haemorrhagic stroke within the previous 4 weeks (2 weeks where possible) 3. Demonstrate upper-limb deficits (defined as a National Institute of Health Stroke Scale, NIHSS, Motor Arm score of 1-4 on admission) 4. Baseline Action Research Arm Test of less than 50, indicating significant arm and hand dysfunction 5. Are eligible to receive onward physical rehabilitation either in the community or another rehabilitation setting 6. Can comprehend simple verbal instructions assessed by Oxford Cognitive Screen and 4 items from a subset of the COMPASS Assessment to assess ability to complete multiple-step instructions 7. Can provide feedback on experiences (with support from a carer if required) 8. Are likely to be able to undertake mental practice, evidenced by a score indicating more than 50% correctness on hand laterality judgement test (5/10)
Exclusion criteria
Exclusion criteria: 1. Patients who do not have capacity to consent despite materials being available in accessible formats and other languages 2. Have significant hearing loss despite corrective aids 3. Are not fluent (listening) in English, Polish, Indian Punjabi or Urdu 4. Receiving end-of-life care 5. Have significant other impairment of the upper limb such as frozen shoulder, complex regional pain syndrome, orthopaedic injury that would prevent completion of movements required for the outcome measurements 6. Have health conditions that limit or prevent engagement with rehabilitation 7. Currently participating in another stroke rehabilitation trial 8. Are likely to be discharged to a location outside a practical working distance from the recruitment location during the intervention or follow-up period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locations recruited, participants screening, proportion of screen patients recruited to study, and recruitment rate, measured using screening log and recruitment data at enrolment;Proportion of recruited participants remaining in the study measured using recruitment, follow-up and withdrawal data at 6 weeks (end of intervention) and 3 months (follow up);Engagement data collected by MyArm (digital platform): actual use as a proportion of recommended total number of sessions (5 sessions a week) measured using app usage tracking at 6 weeks;Engagement data collected by MyArm (digital platform): dose as a proportion of recommended use (100 minutes per week) measured using app usage tracking at 6 weeks;Process evaluation measured using semi-structured interviews of purposively selected participants to reflect those who did not complete the intervention (<50% sessions completed n = up to 10), those who completed either intervention or control (n = up to 20) intervention and clinical staff delivering usual care (up to n = 12) at throughout the study duration;Upper extremity activities limitations measured using Action Research Arm Test at baseline, end of intervention and follow-up;Upper extremity impairment measured using the Fugl-Meyer Upper Extremity Assessment at baseline, end of intervention and follow-up;Fatigue severity measured using the Fatigue Severity Scale at baseline, end of intervention and follow-up;Quality of life measured using EQ-5D-5L at baseline, end of intervention and follow-up;Outcome tool completion rates measured using eligibility, baseline and follow-up data at 6 weeks and 3 months;Qualitative insights from process evaluation measured using semi-structured process evaluation interviews at throughout the study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcomes | — |
Countries
England, United Kingdom
Contacts
Public ContactAlison Gibbon
Outcome results
None listed