Topic: Stroke
Conditions
Interventions
1. Feasibility RCT:
Participants will be randomly allocated to one of two groups: intervention or control.
Those assigned to the intervention group will receive electr
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria – patient participants for the feasibility RCT 1. Patients with a confirmed clinical diagnosis of stroke AND it is their first stroke event to affect their upper limb 2. Patients aged 18 years or over 3. Impaired arm movement and strength resulting in reduced function, caused specifically by the stroke. (as determined by the arm subsection score of the National Institute for Health Stroke Scale (NIHSS) Carer participants for the feasibility RCT Inclusion criteria 1. Nominated carer for a patient participating in the feasibility RCT Eligibility criteria – Patient and carer interviews 1. Participating in the main feasibility RCT 2. Mental capacity to consent and take part in the interview 3. Able to understand English 4. Nominated carer supporting a participant in the main feasibility RCT 5. Mental capacity to consent and take part in the interview 6. Able to understand English Therapist Focus Discussion Groups 1. HCPC registered occupational therapist or physiotherapist 2. Currently employed by NUH NHS Trust and working on the Nottingham Stroke Unit 3. Experience of supporting at least one participant to use the ES intervention
Exclusion criteria
Exclusion criteria: Patient participants for the feasibility RCT 1. Patients with a previous history of stroke affecting their upper limb will be excluded as a chronic limb condition from a previous stroke could affect the results 2. Patients will also be excluded with peripheral nerve injury of the upper limb; an existing orthopaedic condition affecting the upper limb; fixed contractures at the elbow, wrist or fingers; malignancy in the area of the ES electrode placement; or epilepsy 3. Patients with a cardiac pacemaker or similar implanted device. 4. Pregnancy 5. Undiagnosed pain or skin conditions (i.e. not related to the stroke) Carer participants for the feasibility RCT 1. Non English speaking Patient and carer interviews Patient 1. Individual is unable to communicate verbally or in written form 2. NonEnglish speaking 3. Aged younger than 18 years Carer 1. Individual is unable to communicate verbally or in written form 2. NonEnglish speaking 3. Aged younger than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the research is to evaluate the feasibility of running a randomised controlled trial that will test the efficacy of delivering early, intensive ES to prevent post stroke complications (such as pain and contractures) to the paretic (weak) upper limb after stroke. The primary outcome measures: 1. Feasibility of the trial design (12 months) - Recruitment rates: number / % of participants recruited within 72 hours post-stroke; time post-stroke that participants received their first treatment; recruitment strategy: number / % of patients screened, number / % eligible and approached, number / % who consented, number / % excluded after screening; Completion rates: number / % of participants who completed the intervention; Number / % of participants who received ES twice a day, 5 days a week whilst in hospital, and number / % who continued with the treatment regime after discharge. Mean, min and max number of ES treatments that participants received during the 3 month intervention period; Recruitment of patients lacking mental capacity to consent for themselves: consultee consent rates (number / % of patients unable to give informed consent, and number consented by a consultee, number of consultees who declined consent). 2. Tolerability (12 months) – Proportion of participants who withdraw or decline intervention; records of interventions declined and why. 3. Integrity of the study protocol (12 months) – Measured by examining how many participants are able to complete the study, % of missing data, and % of people who completed each of the outcome measures at 3, 6 and 12 month follow-up, calculation of the cost of running the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NIHSS score (0, 3, 6, 12 months) – neurological outcome and degree of recovery 2. Barthel ADL Index score and modified Rankin score (0, 3, 6, 12 months) – Independence (functional ability) in basic daily activities 3. Scale of Pain Intensity (SPIN) (0, 3, 6, 12 months) – Pain in the affected arm 4. Muscle contractures (reduction in range of movement and spasticity) (0, 3, 6, 12 months) – muscle contractures will be monistored by measuring muscle activity during assessments using Biometrics equipment 5. Action Research Arm Test (ARAT) (0, 3, 6, 12 months) – arm function 6. Stroke Specific Quality of Life scale (SS-QOL) (0, 3, 6, 12 months) – stroke related quality of life 7. EuroQoL-5D (EQ-5D) (0, 3, 6, 12 months) – health status 8. Patient resource use (cost) questionnaire (0, 3, 6, 12 months) – a measure of resource use and health related costs 9. Caregiver strain Index (CSI) (0, 3, 6, 12 months) – Carer strain 10. Nottingham Extended ADL (NEADL) (0 months) – pre-morbid functional state 11. The Montreal Cognitive Assessment (MoCA) (0 months) – Cognitive status at baseline | — |
Countries
United Kingdom
Outcome results
None listed