Electrical Stimulation to prevent Complications in the Arm Post-Stroke (ESCAPS) – A feasibility study
Overview
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.
The ESCAPS study will evaluate the feasibility of running a definitive trial to ascertain the efficacy of using early, intensive ES therapy to prevent post stroke complications in the affected arm. The qualitative aspect of the feasibility study will explore possible barriers and facilitators to protocol adherence.
Project Lead: Dr Joanna Fletcher-Smith
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.
The aim of the ESCAPS study is to evaluate the feasibility of running a randomised controlled trial that will test the efficacy of delivering early, intensive electrical stimulation (ES) into both the forearm flexor muscles and the forearm extensor muscles with an aim to prevent post-stroke complications in the paretic upper limb after stroke.
This feasibility study will identify the issues in running a definitive trial, and will include an integrated qualitative study (patient/carer interviews and therapist focus discussion groups) to ensure that the intervention remains acceptable to patients and to ascertain any barriers to compliance with the protocol. 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 gours after stroke is appropriate.
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The ES regime proposed is feasible, as measured by compliance and attrition.
FAQs
1. How many trial participants do you need?
We will aim to recruit 40 participants for the main feasibility randomised controlled trial. We will also aim to recruit 15 carers of the ESCAPS study participants to take part in interviews.
2. Where is recruitment taking place?
Recruitment is taking place at the Stroke Unit of the Nottingham University Hospitals NHS Trust.
3. I am a stroke survivor, am I eligible to take part?
For this single-centre feasibility study we will only be recruiting acute stroke patients from the Nottingham Stroke Unit. We aim to recruit patients within 72 hours of having their stroke. If you or your relative have recently had a stroke and are being treated on the Nottingham Stroke Unit then you may be approached on the ward to take part in this research.
4. How long will the study run for?
The ESCAPS study will run for a total of 3 years. Participants enrolled in the trial will be involved for a total period of 12 months. Thos randomly assigned to the intervention group will receive the ES therapy for 3 months. All participants will be followed up at 3 months, 6 months and 12 months.
5. What treatment are you testing?
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.
We will be testing the application of ES to the forearm flexor and extensor muscles early after stroke. We wish to test the feasibility of teaching patients and their carers to continue the treatment post discharge as part of a self-management programme. Participants will receive ES therapy twice a day for 30 minutes, five days a week for a total treatment duration of three months.
6. How does electrical stimulation (ES) therapy work?
ES machines deliver a small (harmless) current that depolarizes a nerve leading to two actions: a contraction of a muscle via a motor nerve; and a sensory signal to the brain and spinal cord by stimulation of the associated sensory nerves. The stimulation of a muscle causes a force producing contraction that is broadly similar to a naturally produced contraction which can be used to prevent muscle wastage. The sensory stimulation of the brain and spinal cord can contribute to neuroplasticity, and reduction of pain. The stimulation of the flexors reciprocally with the extensors simulates the natural stretching movements and can be more effective in the prevention of contractures than just stimulation of the extensors. Flexor stimulation has been shown to reduce spasticity as opposed to being a contraindication. ES could provide more intense and prolonged arm re-education alongside regular routine therapy with no extra therapist input.
7. How is the study funded?
The study is being funded by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) grant.
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