A preliminary study investigating if muscle stimulation as an exercise
A randomised controlled feasibility study investigating surface neuromuscular STIMulation as an exercise therapy versus usual care in people with multiple sclerosis to help improve lower limb strength, walking and fatigue (STIM-MS)
What it found
No result yet.
What was tested
Treatment tested
- Commercially available
- constant current two channel electrical stimulation device.
What it measured
Main measures
As this is an acceptability and feasibility study there is no primary outcome measure. An objective of this study is to collect data on candidate outcome measures to determine the primary outcome for the future trial and enable sample size calculations based on this.
Feasibility
Other measures (1)
1. Levels of functional disability measured using Expanded disability status scale (EDSS) at screening, 3 and 6 months. 2. Disease and demographic characteristics at baseline (age, sex, ethnicity, height, weight, disease subtype, years since diagnosis, annual relapse rate). 3. Number of relapses (total). 4. Level of impairment measured using type and number of walking aids used 5. Muscle function/
Disability progressionRelapsesThinking and memoryFatigueWalking and mobilityPhysical functionSpasticityPainQuality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 100
Show the full criteria
Inclusion criteria
Inclusion: People with multiple sclerosis (MS): 1 Adults with primary progressive, secondary progressive or relapsing-remitting multiple sclerosis. 2. Expanded disability status scale score ≥4.0 and ≤6.5. 4= Significant disability, self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m. 6.5= Requires two walking aids to walk about 20m without resting). Carers or people who help look after people with MS who were involved in the study: - This includes provision of informal or formal care, assistance with activities related to the study including attendance of hospital visits, use of the surface neuromuscular electrical stimulation device, recording of information related to healthcare visits, physical activity or exercise. Healthcare practitioners and staff involved in the study: - Healthcare practitioners and staff (clinical and non-clinical) who were involved in the set-up or delivery of the study. Exclusion: People with Multiple Sclerosis: 1. Clinically isolated syndrome. 2. People with multiple sclerosis in an active relapse or <8-weeks since a relapse. 3. Lower-limb peripheral nerve injury. 4. Fixed lower-limb contractures. 5. Contraindications to surface neuromuscular electrical stimulation i.e. 5.1. Pregnancy 5.2. Uncontrolled Epilepsy 5.3. Any of the following in the lower limbs: i) Peripheral nerve injury ii) Unstable fractures or orthopaedic condition affecting the lower limb iii) Cancer (malignancy) in the areas of the electrode placement iv) Skin infection / devitalised skin at the electrode placement site 6. Unable to apply and control surface neuromuscular electrical stimulation device or braces independently or with carer assistance. 7. Other co-morbidities that could affect mobility/additional underlying condition e.g. stroke. Cardiac pacemaker/history of cardiac problems will not be a reason for exclusion but recruitment will be subject to cardiologist approval. Carers of people with MS who were involved in the randomised controlled trial: 1. Carers of people who help look after people with MS but were not involved in the study will not be eligible. Healthcare practitioners and staff involved in the study: 1. Healthcare practitioners or staff not involved in setting up or delivering the study
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Multiple sclerosis (MS) is a condition where the body mistakenly attacks the brain and nerves, causing damage. MS is a lifelong condition that can worsen over time, leading to muscle tiredness, weakness, and balance problems, which can make walking difficult. Exercise can help, but many people with MS find it challenging due to tiredness, balance issues, needing help, and lack of confidence. Muscle stimulation might help people with MS exercise more easily. It can be done at home using sticky pads on the skin that send painless electrical signals to make muscles contract, similar to exercising with weights. This could help prevent worsening muscle weakness, improve walking ability, increase physical activity, and reduce tiredness, helping people stay independent for longer. The aim of this study is to gather information to plan a larger study to see if muscle stimulation can strengthen muscles, improve walking, reduce tiredness, and decrease muscle spasms in people with MS. Who can participate? People with MS can participate in this study if they: - Have any form of MS - Have problems with walking but can walk at least 20 meters without resting (with or without walking aids) What does the study involve? The study will involve 50 people with MS from two hospital clinics in Liverpool and Wolverhampton. Half of the participants, chosen randomly by a computer, will receive muscle stimulation along with their usual care. They will use the muscle stimulation equipment at home on their legs for 12 weeks. The other half will continue with their usual care. Participants will have their muscle strength, walking ability, muscle spasms, and levels of tiredness measured at the start, after 3 months, and after 6 months. Both groups, along with their carers and clinicians, will be asked about their experiences with the study and reasons for not participating. What are the possible benefits and risks of participating? Benefits: There are no guaranteed direct benefits, but participants will help gather information to plan a future study. The future study aims to see if muscle stimulation can help people with MS improve walking, get stronger, and feel less tired. Risks or disadvantages: Participants may not be placed in the group they prefer, which can be disappointing. The skin may become red or irritated from the sticky pads, but this usually goes away quickly once stopped. Some people might find the sensation uncomfortable at first but usually get used to it. Participation requires time for visits and completing questionnaires. Where is the study run from? The study is being conducted at two hospital clinics in Liverpool and Wolverhampton. When is the study starting and how long is it expected to run for? November 2024 to October 2027 Who is funding the study? The study is funded by the National Institute for Health and Care Research (NIHR207134) (UK) Who is the main contact? Dr Fraser Philp, f.philp@liverpool.ac.uk
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History
Started
Oct 2025
Finished
Oct 2027