A surface neuromuscular electrical stimulation (SNMES) protocol for people with leg weakness within 2 weeks after a stroke Circulatory System
Conditions
Interventions
This study will be a randomised controlled (RCT) feasibility study with a nested qualitative and economic component. A feasibility study is being used to explore recruitment, data collection methods,
Sponsors
University Hospitals Dorset NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for the participants with stroke are: 1. Adults >= 18 years of age within two weeks of diagnosis of acute stroke 2. Sufficiently medically stable to participate in rehabilitation/trial interventions 3. National Institutes of Health Stroke Scale (NIHSS) score of >= 3 for the lower limb (limb weakness) 4. Unable to walk or transfer independently (with/without a walking aid) Inclusion criteria for caregivers of people with stroke: 1. Caregiver or family member to participant with stroke defined as: 1.1. An informal caregiver (hereafter referred to as caregivers) who is a family member or a close friend in a good relationship with the person with a stroke. 1.2. The caregiver will be older than 18 years of age 1.3. Able to communicate and assist the stroke survivor 2. The participant with stroke that they support was in the intervention group (SNMES) 3. Caregiver or family member has the communication skills to be able to participate in an interview Inclusion criteria for clinicians: 1. Health care worker (e.g. but not limited to physiotherapist, occupational therapist, therapy technician/aid, nurse, healthcare assistant) 2. Supported the participants with stroke to use the SNMES during the study period
Exclusion criteria
Exclusion criteria: The exclusion criteria for the participants with stroke are: 1. Inability to gain informed consent from the patient or a consultee 2. Inability to walk independently prior to the stroke (with or without a walking aid) 3. Peripheral nerve injury to lower limb muscles 4. Pregnancy 5. Lower limb joint contractures 6. Contraindications to SNMES (DVT, uncontrolled epilepsy, malignancy at site of electrode placement, unstable fracture). 7. Poor skin condition and integrity at electrode sites (e.g. skin infection) 8. Previous stroke with residual lower limb weakness from first stroke 9. Impaired circulation in lower extremities 10. Additional underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s Disease 11. Cardiac pacemaker (the number of participants that have a cardiac pacemaker will be collected during screening, this will help to inform the development of the definitive trial and the inclusion and exclusion criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following feasibility and acceptability variables will be measured using study data at the end of the study: 1. Overall recruitment rate 2. Rate of incomplete 6-month follow-up data 3. Intervention adherence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility and acceptability of the SNMES intervention started within 2 weeks in people after stroke will be explored via interviews with people with stroke and their caregivers following their participation in the study. 2. Screening, recruitment and attrition rates, and reasons for declining participation or leaving the study early will be collated at the end of the study 3. Adherence/engagement to the SNMES protocol, including the number of sessions completed/total sessions in treatment protocol, will be monitored via the participant diary and usage records obtained from the SNMES device at the end of the study. 4. Acceptability of the outcome measures, data collection methods, and data completeness will be explored via interviews with people with stroke and their caregivers following their participation in the study. 5. The intended primary outcome for a definitive trial would be the 10-Metre Walk Test (assessed at 12 weeks and 6 months). Data will be collected to estimate the mean and standard deviation of this outcome to inform power calculation for a definitive trial. 6. Whether the protocol can be incorporated within routine clinical practice will be explored via interviews with people with stroke and their caregivers following their participation in the study. 7. Feasibility of delivering SNMES in a range of settings, e.g. hospital, rehabilitation, and home, will be explored via interviews with people with stroke and their caregivers following their participation in the study. 8. Whether the participant sample is representative of the local areas of recruitment and national stroke survivors will be explored by analysing demographics and outcome data at the end of the study to develop and implement an inclusive recruitment strategy for a definitive trial 9. Resource use will be assessed via bespoke resource use questionnaires at 6 weeks, 12 weeks and 6 months. 10. Effectiveness and ease of use of the resource use questionnaires will be assessed at the en | — |
Countries
England, United Kingdom
Contacts
Public ContactKatey Collins
Outcome results
None listed