Title: Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm - a feasibility study
Funder: Department of Health and Social Care

Abstract: Stroke is the largest cause of adult disability in the UK3. Reduced arm movement and loss of hand function is a common consequence of stroke affecting 70% of acute stroke patients4. Loss of function reduces independence in activities of daily living5. This dependency is persistent and disabling for around 40% of stroke survivors4. Arm weakness can result in stroke-related complications such as pain and muscle contractures leading to joint deformity. Stroke patients are unlikely to receive 45 minutes of therapy, as recommended6. Due to valid practical consideration, the trunk and lower limb are prioritised at the expense of the upper limb as the focus is to improve mobility. There is evidence to support early interventions after stroke, and strong evidence that intensity of treatment is an important factor in the effectiveness of rehabilitation7,8. ES can be used to activate the muscles and therefore prevent the complications that arise due to disuse, whilst facilitating neuroplasticity by providing sensory stimulation to the brain. There is evidence that ES of the wrist extensors improves recovery9. Therefore ES offers a potential treatment for use very early after stroke to prevent avoidable secondary complications, but further research is required to prove efficacy. Aims This research is to evaluate the feasibility of running a randomised controlled trial that will test the efficacy of delivering early, intensive ES to both the forearm flexors and extensors with an aim to prevent post stroke complications in the paretic upper limb after stroke. The specific aims are to determine whether: It is feasible to recruit within 72 hours after stroke, and ascertain recruitment. Initiating ES therapy within 72 hours after stroke is appropriate. The ES regime proposed is feasible, as measured by compliance and attrition. We will also study the interaction between compliance and response to treatment in order to identify the optimum compliance needed for the main study, refine the inclusion/exclusion criteria, and determine the outcome measures, blinding method and any barriers to compliance from both the therapist and patient perspectives. Plan of investigation This feasibility study will consist of a randomised controlled trial design to test the issues in running a definitive trial, and will include an integrated qualitative study (patient/carer interviews and therapist discussion groups) to ensure that the intervention remains acceptable to patients and to ascertain any barriers to compliance with the protocol. Patients will be recruited within 72 hours after first stroke event. Patients with reduced arm function in the paretic arm (defined by the motor arm subsection of the National Institute for Health Stroke Scale (NIHSS)) will be eligible for the study. Baseline assessments (pain, contractures, arm function, quality of life, and pre-stroke level of function) will be completed prior to randomisation. Participants assigned to the intervention group will receive routine therapy and ES twice a day, 5 days a week, for 3 months. The therapist will set the device and teach participants and/or carers how to use the device. This will enable the patient to continue the treatment independently as part of a self-management programme. Participants randomised to the control group will receive usual care, i.e. routine therapy but no ES. Outcome measures will be completed at 3, 6 and 12 months post randomisation. Potential benefits to patients and the NHS Almost half of all stroke survivors have loss of hand function, muscle weakness, pain, and joint deformities that are persistent and disabling. ES could provide a cost-effective solution to preventing or reducing post-stroke complications. If proven effective, ES would facilitate recovery of function and reduce the cost of treating secondary complications and therefore lessen the burden to the state.

Lay abstract: Stroke is the largest cause of adult disability in the United Kingdom. Loss of hand function, muscle weakness, pain, and joint deformities are persistent and disabling problems for nearly half of all stroke survivors. This can, in part, result from patients not getting adequate therapy targeting the hand and arm in the very early stages of rehabilitation. Previous research has highlighted the importance of early rehabilitation interventions after stroke. Although in stroke patients the damage is to the brain rather than the limbs, muscle wastage (atrophy) can occur soon after stroke through non-use. Muscle atrophy can even occur in those who have retained some degree of active arm movement. Electrical stimulation (ES) is a painless treatment in which small pulses of electrical current from a battery operated portable device are used to activate a paralysed muscle and produce a strong muscle contraction. ES has been shown to increase brain activity and can hence influence the formation of new nerve pathways (known as neuroplasticity) to replace those damaged by stroke. Previous studies have concluded that six weeks of ES to the muscle on the back of the forearm improved the chance of a person recovering arm function. However, as the intensity of treatment was not sufficient to prevent the complications identified in this proposal, the impact of any functional benefit was significantly limited. We plan to build on previous research by training clinical therapists to operate ES devices; starting ES much earlier after stroke; applying a higher intensity treatment to more of the forearm muscles (i.e. both the front and back of the forearm) and providing treatment for a longer period of time than previously carried out. We will evaluate the feasibility of incorporating ES into a patient self-management programme to enable independent use outside of routine therapist led rehabilitation sessions.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;6.7 PHYSICAL
Health categories: STROKE