Using surface neuromuscular electrical stimulation for lower limb weakness early afterstroke: A randomised controlled feasibility study

Research Question Is surface neuromuscular electrical stimulation (SNMES) feasible and acceptable to use for people immediately following stroke to prevent muscle loss? Background Stroke is a leading cause of disability.

Despite improvements in mortality, 46% of people are not able to walk five days after stroke, resulting from continued weakness in the lower extremity, many remain unable to walk in the long-term. SNMES is an intervention to target lower extremity strength and may help recovery of walking.

Aims Explore the feasibility and acceptability of SNMES to inform the design of a future definitive RCT testing whether SNMES started within two-weeks after stroke prevents muscle wastage and improves recovery of strength, walking and quality of life in people with severe lower extremity weakness. Primary Objective Determine the feasibility and acceptability of the SNMES intervention started two weeks after stroke.

Secondary Objectives Estimate screening, recruitment and attrition rates, and reasons for declining participation or leaving the study early Estimate adherence to the SNMES protocol Determine the acceptability of the outcome measures, data collection methods and data completeness Collect data to inform sample size for a definitive trial Determine whether the protocol can be incorporated within routine clinical practice Methods A randomised controlled feasibility study with a nested qualitative component.

Participants will be randomised to receive SNMES or usual care.

Intervention Group In addition to their usual rehabilitation, participants in this group will get additional treatment with SNMES to their stroke-affected leg muscles (quadriceps, hamstring, anterior tibialis, and gastrocsoleus) three times a week for 12-weeks. Each session will involve 45 muscle contractions, lasting around 30 minutes in total.

Control Group The control group will continue to receive their usual rehabilitation.

Outcome Measures and Follow Up All participants will complete outcome measures assessing strength, function, and quality of life at baseline, 6-weeks, 12-weeks and 6-months post randomisation.

Participants from the intervention and control groups and caregivers/significant others will be invited to take part in semi-structured interviews exploring their experiences and the acceptability of using SNMES. Clinicians working with the stroke survivors will be invited to take part in focus groups.

Analysis Quantitative data will be analysed using descriptive statistics, effect sizes will be calculated where appropriate. Qualitative data will be analysed using thematic analysis (framework methods). Progression criteria will be explored using Red-Amber-Green (RAG) traffic light criteria. Timeline for Delivery The study duration is 24 months.

Study set up and training 3-months, 12-months recruitment and data collection, 6-month follow up after the last participant is recruited, and 3-months for analysis and study write-up.

Anticipated Impact and Dissemination The research will inform the development of a definitive trial exploring if SNMES applied in subacute stroke can help prevent muscle wastage and facilitate earlier return to walking.

If successful, SNMES provides an intervention for a group of people for whom there are few evidence-based interventions available for strengthening and prevention of muscle wastage.

Findings will be disseminated through academic journals, national and international conferences, public events, and social media in collaboration with our public member co-applicant.